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Build Better Bones With Exercise (B3E)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761084
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
University Health Network, Toronto
McMaster University
University of Melbourne
University of British Columbia
Information provided by (Responsible Party):
University of Waterloo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Osteoporotic Fractures
Spinal Fractures
Intervention Behavioral: Exercise and behaviour change strategies
Enrollment 141
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Period Title: Overall Study
Started 71 70
Completed 66 64
Not Completed 5 6
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion Total
Hide Arm/Group Description

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. Total of all reporting groups
Overall Number of Baseline Participants 71 70 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 70 participants 141 participants
76  (6.4) 77  (7.28) 76  (6.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 141 participants
Female
71
 100.0%
70
 100.0%
141
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Feasibility of Recruitment and Retention
Hide Description Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Time Frame Monthly records up to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Measure Type: Count of Participants
Unit of Measure: Participants
66
  93.0%
64
  91.4%
2.Primary Outcome
Title Adherence
Hide Description Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.
Time Frame Monthly records over 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only the Exercise Group received the exercise program.
Arm/Group Title Exercise and Behaviour Change Strategies
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Overall Number of Participants Analyzed 71
Mean (Full Range)
Unit of Measure: % of weeks meeting adherence threshold
66
(17 to 86)
3.Secondary Outcome
Title Number of Fractures.
Hide Description Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method.
Time Frame Baseline, one year and at report of fracture (monitored monthly for reports).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: Fractures
Baseline 168 163
12 Month Follow-up 183 178
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
.58 to 1.94
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Fallers
Hide Description Diary for participants to self-report falls.
Time Frame Monthly up to one year.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Measure Type: Count of Participants
Unit of Measure: Participants
48
  67.6%
36
  51.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
.99 to 1.74
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Occiput to Wall Distance
Hide Description [Not Specified]
Time Frame Baseline and one year.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: centimetres
Baseline 5.3  (4.0) 6.2  (4.7)
Month 12 5.3  (4.4) 6.1  (3.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.811
Comments [Not Specified]
Method t-test, 2 sided
Comments Intention-to-treat analysis
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.84 to 1.07
Estimation Comments Intention-to-treat analysis
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Month 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.80 to 1.09
Estimation Comments Per-protocol analysis
6.Secondary Outcome
Title Scores on the Short Physical Performance Battery (SPPB)
Hide Description The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance.
Time Frame Baseline and one year.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 9.6  (2.2) 8.8  (2.3)
12 months 9.7  (2.5) 9.0  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.796
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.80 to 0.61
Estimation Comments Intention-to-treat analysis
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Month 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.888
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.75 to 0.65
Estimation Comments Per-protocol analysis
7.Secondary Outcome
Title Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
Hide Description Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance.
Time Frame Baseline and one year.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 13.5  (2.2) 13.2  (2.0)
Month 12 13.6  (2.6) 13.2  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.719
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.54 to 0.78
Estimation Comments Intention-to-treat analysis
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Month 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.56 to 0.79
Estimation Comments Per-protocol analysis
8.Secondary Outcome
Title Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS).
Hide Description OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain.
Time Frame Baseline, 6 months and one year.
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawals at 6 months – intervention group (n=4) and control group (n=5). Withdrawals at 12 months – intervention group (n=5) and control group (n=6).
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
EQ5D-VAS - Baseline Number Analyzed 71 participants 70 participants
74.1  (19.1) 75.7  (20.0)
EQ5D-VAS - Month 6 Number Analyzed 67 participants 65 participants
75.5  (17.6) 75.7  (18.8)
EQ5D-VAS - Month 12 Number Analyzed 66 participants 64 participants
74.6  (19.1) 75.7  (15.4)
OQLQ - Average - Baseline Number Analyzed 71 participants 70 participants
5.1  (1.3) 5.2  (1.2)
OQLQ - Average - Month 6 Number Analyzed 67 participants 65 participants
5.4  (1.2) 5.6  (1.2)
OQLQ - Average - Month 12 Number Analyzed 66 participants 64 participants
5.4  (1.4) 5.4  (1.3)
Pain VAS at Rest - Baseline Number Analyzed 71 participants 70 participants
2.7  (2.7) 2.4  (2.1)
Pain VAS at Rest - Month 6 Number Analyzed 67 participants 65 participants
2.3  (2.4) 2.1  (2.1)
Pain VAS at Rest - Month 12 Number Analyzed 66 participants 64 participants
1.9  (2.2) 2.1  (2.2)
Pain VAS Movement - Baseline Number Analyzed 71 participants 70 participants
3.8  (2.9) 4.2  (2.6)
Pain VAS Movement - Month 6 Number Analyzed 67 participants 65 participants
3.0  (2.4) 3.5  (2.5)
Pain VAS Movement - Month 12 Number Analyzed 66 participants 64 participants
3.6  (2.7) 3.9  (2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in EQ5D - VAS
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
-5.66 to 6.83
Estimation Comments Intention-to-treat analysis
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in EQ5D-VAS
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
-4.66 to 8.22
Estimation Comments Per-protocol analysis
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in OQLQ Average Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.335
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.16 to 0.47
Estimation Comments Intention-to-treat analysis
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in OQLQ Average Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.15 to 0.50
Estimation Comments Per-protocol analysis
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in pain VAS at rest
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.225
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-1.36 to 0.32
Estimation Comments Intention-to-treat analysis
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in pain VAS at rest
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.488
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-1.16 to 0.56
Estimation Comments Per-protocol analysis
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in pain VAS during movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.68 to 0.88
Estimation Comments Intention-to-treat analysis
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in pain VAS during movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.566
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.57 to 1.04
Estimation Comments Per-protocol analysis
9.Secondary Outcome
Title Scores on Exercise Self-efficacy Scales.
Hide Description To assess self-efficacy related to engaging in exercise, participants will be asked "Over the next 3 months, how confident are you that you can perform exercise on most days of the week?" and "Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?." To assess implementation intentions, participants are asked "Do you already have concrete plans regarding exercise?". Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy.
Time Frame Baseline, 6 months and one year.
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawals at 6 months – intervention group (n=4) and control group (n=5). Withdrawals at 12 months – intervention group (n=5) and control group (n=6)
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 71 participants 70 participants
4.4  (0.7) 4.4  (0.6)
Month 6 Number Analyzed 67 participants 65 participants
4.2  (0.7) 4.0  (0.8)
Month 12 Number Analyzed 66 participants 64 participants
4.0  (0.8) 4.0  (0.7)
10.Secondary Outcome
Title Score on Short-form Falls Efficacy Scale International (FES-I).
Hide Description Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling.
Time Frame Baseline, 6 months and one year.
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawals at 6 months – intervention group (n=4) and control group (n=5). Withdrawals at 12 months – intervention group (n=5) and control group (n=6).
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 71 participants 70 participants
12.1  (4.8) 12.9  (5.6)
Month 6 Number Analyzed 67 participants 65 participants
11.4  (4.0) 11.5  (4.7)
Month 12 Number Analyzed 66 participants 64 participants
11.5  (4.7) 12.3  (5.0)
11.Secondary Outcome
Title Productivity
Hide Description Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work.
Time Frame Monthly up to one year.
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who reported working and/or volunteering were asked this question.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 19 participants 20 participants
1.89  (2.536) 1.85  (1.927)
Month 1 Number Analyzed 20 participants 17 participants
1.60  (2.257) 1.76  (1.985)
Month 2 Number Analyzed 19 participants 17 participants
1.32  (2.212) 2.12  (1.965)
Month 3 Number Analyzed 19 participants 17 participants
1.21  (2.149) 2.94  (2.947)
Month 4 Number Analyzed 18 participants 18 participants
1.00  (1.910) 2.50  (2.307)
Month 5 Number Analyzed 18 participants 14 participants
0.11  (.471) 1.57  (1.910)
Month 6 Number Analyzed 16 participants 17 participants
0.69  (1.778) 1.88  (2.261)
Month 7 Number Analyzed 15 participants 14 participants
.80  (1.781) 2.07  (2.556)
Month 8 Number Analyzed 14 participants 16 participants
0.93  (2.056) 2.00  (2.191)
Month 9 Number Analyzed 14 participants 17 participants
1.07  (2.556) 1.76  (2.333)
Month 10 Number Analyzed 20 participants 17 participants
0.95  (2.089) 1.24  (1.855)
Month 11 Number Analyzed 16 participants 18 participants
0.88  (2.029) 1.83  (2.503)
Month 12 Number Analyzed 21 participants 19 participants
0.76  (2.022) 2.16  (2.115)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .951
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.045
Confidence Interval (2-Sided) 95%
-1.412 to 1.501
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Month 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.396
Confidence Interval (2-Sided) 95%
-2.721 to -0.071
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Physical Activity
Hide Description A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawals at 6 months – intervention group (n=4) and control group (n=5) Withdrawals at 12 months – intervention group (n=5) and control group (n=6)
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: Minutes per week
Baseline Strength/Balance physical activity Number Analyzed 71 participants 70 participants
6.7  (17.0) 6.4  (16.8)
Baseline Moderate-Vigorous physical activity Number Analyzed 71 participants 70 participants
43.2  (138.5) 48.8  (156.1)
Baseline Walking Number Analyzed 71 participants 70 participants
168.8  (366.0) 194.9  (278.3)
Month 6 Strength/Balance physical activity Number Analyzed 67 participants 65 participants
80.8  (85.8) 15.7  (36.4)
Month 6 Moderate-Vigorous physical activity Number Analyzed 67 participants 65 participants
76.1  (143.9) 147.3  (346.0)
Month 6 Walking Number Analyzed 67 participants 65 participants
165.4  (120.6) 154.0  (161.6)
Month 12 Strength/Balance physical activity Number Analyzed 66 participants 64 participants
68.4  (68.3) 21.1  (44.9)
Month 12 Moderate-Vigorous physical activity Number Analyzed 66 participants 64 participants
93.9  (225.9) 128.9  (352.3)
Month 12 Walking Number Analyzed 66 participants 64 participants
161.2  (140.7) 268.0  (342.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Only Month 6 and Month 12 strength and balance physical activity differences were significant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Month 6 strength and balance physical activity
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -65.9
Confidence Interval (2-Sided) 95%
-91.8 to -40.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Only Month 6 and Month 12 strength and balance physical activity differences were significant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Month 12 strength and balance physical activity
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -49.3
Confidence Interval (2-Sided) 95%
-69.8 to -28.8
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Serious Adverse Events.
Hide Description Defined as death or event that is life-threatening, requires hospitalization or results in disability.
Time Frame Monthly up to one year.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: events
18 12
14.Secondary Outcome
Title Number of Individuals Screened and Eligible Per Collection Site.
Hide Description Number of participants randomized out of all participants screened
Time Frame over the course of the study (2.29 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Screened
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2822
Measure Type: Count of Participants
Unit of Measure: Participants
141
   5.0%
15.Secondary Outcome
Title Number of Potentially Eligible Males
Hide Description [Not Specified]
Time Frame over recruitment period
Hide Outcome Measure Data
Hide Analysis Population Description
Total people screened for inclusion
Arm/Group Title Participants Screened
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2254
Measure Type: Count of Participants
Unit of Measure: Participants
308
  13.7%
16.Secondary Outcome
Title Number of Participants With Multiple Falls
Hide Description [Not Specified]
Time Frame Monthly up to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Measure Type: Count of Participants
Unit of Measure: Participants
31
  43.7%
22
  31.4%
17.Secondary Outcome
Title Total Number of Falls
Hide Description [Not Specified]
Time Frame Monthly up to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: Falls
130 127
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Negative Binomial Regression.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio
Estimated Value .97
Confidence Interval (2-Sided) 95%
.58 to 1.63
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Value of Direct Medical Resources Per Participant.
Hide Description [Not Specified]
Time Frame Accrued costs over 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
For each resource cost, only participants utilizing the resource are included.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: Dollars (Canadian)
Medications Number Analyzed 71 participants 67 participants
2127  (3579) 1823  (3063)
Medical costs related to adverse events Number Analyzed 35 participants 23 participants
1680  (3600) 3130  (3180)
Physician visits and tests/ procedures Number Analyzed 65 participants 62 participants
829  (1033) 848  (863)
Allied health professional visits Number Analyzed 5 participants 4 participants
301  (331) 95  (51)
19.Secondary Outcome
Title Value of Non-direct Medical Resources Per Participant.
Hide Description [Not Specified]
Time Frame Accrued costs over 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
For each resource cost, only participants utilizing the resource are included.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: Dollars (Canadian)
Unpaid caregiver time Number Analyzed 50 participants 52 participants
5005  (9220) 4631  (8091)
Lost productivity Number Analyzed 26 participants 17 participants
998  (1642) 917  (1322)
Out of pocket costs Number Analyzed 57 participants 52 participants
1007  (1453) 872  (1250)
20.Secondary Outcome
Title Participant Height
Hide Description [Not Specified]
Time Frame Baseline and one year
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawals at 12 months – intervention group (n=5) and control group (n=6). The remainder (5 intervention, 2 control) did not attend the follow-up visit.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: centimetres
Baseline Number Analyzed 71 participants 70 participants
156.5  (6.4) 156.1  (7.2)
Month 12 Number Analyzed 61 participants 62 participants
156.4  (6.6) 155.9  (7.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in height
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.536
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.28 to 0.53
Estimation Comments Intention-to-treat analysis
21.Secondary Outcome
Title Activities of Daily Living
Hide Description 0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.
Time Frame Monthly up to one year
Hide Outcome Measure Data
Hide Analysis Population Description
Subsequent number of participants drops after baseline due to withdrawals or monthly follow-up not being completed.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 71 participants 70 participants
3.17  (3.005) 3.46  (2.406)
Month 1 Number Analyzed 68 participants 64 participants
2.79  (2.696) 2.75  (2.397)
Month 2 Number Analyzed 69 participants 65 participants
2.99  (2.841) 3.05  (2.446)
Month 3 Number Analyzed 67 participants 65 participants
2.96  (2.946) 3.12  (2.362)
Month 4 Number Analyzed 66 participants 61 participants
3.14  (2.762) 3.34  (2.639)
Month 5 Number Analyzed 64 participants 64 participants
3.45  (2.922) 3.39  (2.741)
Month 6 Number Analyzed 61 participants 61 participants
2.74  (2.613) 2.95  (2.673)
Month 7 Number Analyzed 62 participants 58 participants
2.95  (2.772) 3.33  (2.691)
Month 8 Number Analyzed 61 participants 57 participants
2.98  (2.723) 3.07  (2.389)
Month 9 Number Analyzed 59 participants 58 participants
2.98  (2.831) 3.28  (2.821)
Month 10 Number Analyzed 60 participants 58 participants
2.97  (2.414) 3.14  (2.599)
Month 11 Number Analyzed 59 participants 59 participants
2.90  (2.537) 3.32  (2.381)
Month 12 Number Analyzed 65 participants 64 participants
2.52  (2.599) 2.58  (2.342)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Month 12 scores.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .900
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.055
Confidence Interval (2-Sided) 95%
-0.917 to 0.807
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Timed Loaded Standing Test
Hide Description A physical performance measure of combined trunk and arm endurance.
Time Frame Baseline and one year
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the University of Waterloo and the University of Toronto sites assessed.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 17 13
Median (Standard Deviation)
Unit of Measure: Seconds
Baseline 101.9  (39.8) 107.5  (34.6)
Month 12 120  (39.9) 106  (37.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .712
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.2
Confidence Interval (2-Sided) 95%
-33.6 to 23.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 13.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Month 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .60
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-23.3 to 39.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.3
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Location of Vertebral Fractures
Hide Description Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawals at 12 months – intervention group (n=5) and control group (n=6). The remainder (9 intervention, 8 control) did not have a second x-ray.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: Fractures
Baseline T1-T3 Number Analyzed 71 participants 70 participants
3 1
Baseline T4-T8 Number Analyzed 71 participants 70 participants
54 42
Baseline T9-L1 Number Analyzed 71 participants 70 participants
74 88
Baseline L2-L5 Number Analyzed 71 participants 70 participants
38 36
Month 12 T1-T3 Number Analyzed 57 participants 56 participants
3 2
Month 12 T4-T8 Number Analyzed 57 participants 56 participants
43 39
Month 12 T9-L1 Number Analyzed 57 participants 56 participants
66 76
Month 12 L2-L5 Number Analyzed 57 participants 56 participants
34 28
24.Secondary Outcome
Title Participant Weight
Hide Description [Not Specified]
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Withdrawals at 12 months – intervention group (n=5) and control group (n=6). The remainder (7 intervention, 2 control) either did not attend the follow-up visit or did not have access to a scale at the visit.
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description:

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
Overall Number of Participants Analyzed 71 70
Mean (Standard Deviation)
Unit of Measure: kilograms
Baseline Number Analyzed 71 participants 70 participants
65.1  (12.8) 66.5  (15.4)
Month 12 Number Analyzed 59 participants 62 participants
66.1  (13.3) 66.6  (15.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise and Behaviour Change Strategies, General Health or Social Discussion
Comments Comparison of change from baseline in weight
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.461
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.25 to 0.55
Estimation Comments Per-protocol analysis
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exercise and Behaviour Change Strategies General Health or Social Discussion
Hide Arm/Group Description

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
All-Cause Mortality
Exercise and Behaviour Change Strategies General Health or Social Discussion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)      0/70 (0.00%)    
Hide Serious Adverse Events
Exercise and Behaviour Change Strategies General Health or Social Discussion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/71 (23.94%)      12/70 (17.14%)    
Blood and lymphatic system disorders     
Anemia  1/71 (1.41%)  1 0/70 (0.00%)  0
Cardiac disorders     
Heart failure  1/71 (1.41%)  2 0/70 (0.00%)  0
Atrial fibrillation  1/71 (1.41%)  1 0/70 (0.00%)  0
Dizziness [1]  1/71 (1.41%)  1 0/70 (0.00%)  0
Chest pain  1/71 (1.41%)  1 0/70 (0.00%)  0
Elevated blood pressure [2]  0/71 (0.00%)  0 1/70 (1.43%)  1
General disorders     
Idiopathic severe left foot pain  1/71 (1.41%)  1 0/70 (0.00%)  0
Severe vertigo  0/71 (0.00%)  0 1/70 (1.43%)  1
Infections and infestations     
Pneumonia  1/71 (1.41%)  1 2/70 (2.86%)  2
Influenza  1/71 (1.41%)  1 0/70 (0.00%)  0
Stomach infection  1/71 (1.41%)  1 0/70 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  4/71 (5.63%)  4 1/70 (1.43%)  1
Wound infection  1/71 (1.41%)  1 0/70 (0.00%)  0
Vertebral pain  1/71 (1.41%)  1 0/70 (0.00%)  0
Extreme knee pain  0/71 (0.00%)  0 1/70 (1.43%)  1
Musculoskeletal and connective tissue disorders     
Shoulder dislocation  1/71 (1.41%)  1 0/70 (0.00%)  0
Product Issues     
Adverse reaction to Forteo  0/71 (0.00%)  0 1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1/71 (1.41%)  1 1/70 (1.43%)  1
Vascular disorders     
Stroke  0/71 (0.00%)  0 2/70 (2.86%)  2
Aneurysm  0/71 (0.00%)  0 1/70 (1.43%)  1
Hematoma  0/71 (0.00%)  0 1/70 (1.43%)  1
[1]
pulse was really slow and blood pressured dropped. Participant had a history of heart attack.
[2]
palpitations and had very high blood pressure (220/110).
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exercise and Behaviour Change Strategies General Health or Social Discussion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/71 (60.56%)      34/70 (48.57%)    
Cardiac disorders     
Irregular heart beat  0/71 (0.00%)  0 2/70 (2.86%)  2
Ear and labyrinth disorders     
Hearing loss  0/71 (0.00%)  0 2/70 (2.86%)  2
Eye disorders     
Cataracts  1/71 (1.41%)  2 0/70 (0.00%)  0
Macular degeneration  0/71 (0.00%)  0 1/70 (1.43%)  1
General disorders     
Increased pain  15/71 (21.13%)  20 5/70 (7.14%)  9
Dizziness/loss of balance  3/71 (4.23%)  3 0/70 (0.00%)  0
Numbness/tingling in mouth  2/71 (2.82%)  2 0/70 (0.00%)  0
foot edema  1/71 (1.41%)  1 0/70 (0.00%)  0
Hepatobiliary disorders     
Enlarged bile duct  0/71 (0.00%)  0 1/70 (1.43%)  1
Immune system disorders     
Rash  1/71 (1.41%)  1 0/70 (0.00%)  0
Infections and infestations     
Bronchitis  0/71 (0.00%)  0 1/70 (1.43%)  1
corn infected on foot  0/71 (0.00%)  0 1/70 (1.43%)  1
Influenza  2/71 (2.82%)  2 1/70 (1.43%)  1
Fungal infection  1/71 (1.41%)  1 0/70 (0.00%)  0
Gastroenteritis  2/71 (2.82%)  2 1/70 (1.43%)  1
Infected finger  0/71 (0.00%)  0 1/70 (1.43%)  1
Lyme Disease  1/71 (1.41%)  1 0/70 (0.00%)  0
Meniere's Disease  1/71 (1.41%)  1 0/70 (0.00%)  0
Pancreatitis  1/71 (1.41%)  2 0/70 (0.00%)  0
Respiratory infection  4/71 (5.63%)  5 0/70 (0.00%)  0
Shingles  3/71 (4.23%)  3 0/70 (0.00%)  0
Sinus infection  1/71 (1.41%)  1 0/70 (0.00%)  0
Urinary tract infection  0/71 (0.00%)  0 2/70 (2.86%)  4
Injury, poisoning and procedural complications     
Fracture  3/71 (4.23%)  3 3/70 (4.29%)  3
Fall/trip  26/71 (36.62%)  29 12/70 (17.14%)  19
Soft tissue injury  4/71 (5.63%)  5 9/70 (12.86%)  11
Domestic violence incident  0/71 (0.00%)  0 1/70 (1.43%)  1
Musculoskeletal and connective tissue disorders     
arthritis-related pains  4/71 (5.63%)  5 0/70 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cyst  1/71 (1.41%)  1 0/70 (0.00%)  0
Reproductive system and breast disorders     
Vaginal tenderness  0/71 (0.00%)  0 1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders     
Obstructive sleep apnea  1/71 (1.41%)  1 0/70 (0.00%)  0
Idiopathic breathing difficulties  1/71 (1.41%)  1 0/70 (0.00%)  0
Asthma  0/71 (0.00%)  0 1/70 (1.43%)  1
Skin and subcutaneous tissue disorders     
Itchy scalp  1/71 (1.41%)  1 0/70 (0.00%)  0
Surgical and medical procedures     
Skin basal cell carcinoma removed  1/71 (1.41%)  1 0/70 (0.00%)  0
Gallbladder Surgery  1/71 (1.41%)  1 0/70 (0.00%)  0
Bladder cyst surgery  1/71 (1.41%)  1 0/70 (0.00%)  0
Glass splinter removed from finger  1/71 (1.41%)  2 0/70 (0.00%)  0
Endoscopy  0/71 (0.00%)  0 2/70 (2.86%)  2
Facial growth removal  0/71 (0.00%)  0 1/70 (1.43%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lora Giangregorio
Organization: University of Waterloo
Phone: 5198884567 ext 36357
EMail: lmgiangr@uwaterloo.ca
Layout table for additonal information
Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01761084    
Other Study ID Numbers: 18539
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: May 9, 2018
Results First Posted: November 14, 2019
Last Update Posted: November 14, 2019