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
|Condition or disease||Intervention/treatment||Phase|
|Osteoporotic Fractures Spinal Fractures||Behavioral: Exercise and behaviour change strategies||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Exercise and behaviour change strategies
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.
Behavioral: Exercise and behaviour change strategies
No Intervention: General health or social discussion
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.
- Feasibility of Recruitment and Retention [ Time Frame: Monthly records up to 12 months. ]Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
- Adherence [ Time Frame: Monthly records over 12 months ]Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.
- Number of Fractures. [ Time Frame: Baseline, one year and at report of fracture (monitored monthly for reports). ]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.
- Number of Fallers [ Time Frame: Monthly up to one year. ]Diary for participants to self-report falls.
- Occiput to Wall Distance [ Time Frame: Baseline and one year. ]
- Scores on the Short Physical Performance Battery (SPPB) [ Time Frame: Baseline and one year. ]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.
- Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). [ Time Frame: Baseline and one year. ]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.
- 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). [ Time Frame: Baseline, 6 months and one year. ]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.
- Scores on Exercise Self-efficacy Scales. [ Time Frame: Baseline, 6 months and one year. ]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.
- Score on Short-form Falls Efficacy Scale International (FES-I). [ Time Frame: Baseline, 6 months and one year. ]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.
- Productivity [ Time Frame: Monthly up to one year. ]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.
- Physical Activity [ Time Frame: Baseline, 6 months, 12 months ]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.
- Number of Serious Adverse Events. [ Time Frame: Monthly up to one year. ]Defined as death or event that is life-threatening, requires hospitalization or results in disability.
- Number of Individuals Screened and Eligible Per Collection Site. [ Time Frame: over the course of the study (2.29 years) ]Number of participants randomized out of all participants screened
- Number of Potentially Eligible Males [ Time Frame: over recruitment period ]
- Number of Participants With Multiple Falls [ Time Frame: Monthly up to 12 months. ]
- Total Number of Falls [ Time Frame: Monthly up to 12 months. ]
- Value of Direct Medical Resources Per Participant. [ Time Frame: Accrued costs over 12 months ]
- Value of Non-direct Medical Resources Per Participant. [ Time Frame: Accrued costs over 12 months ]
- Participant Height [ Time Frame: Baseline and one year ]
- Activities of Daily Living [ Time Frame: Monthly up to one year ]0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.
- Timed Loaded Standing Test [ Time Frame: Baseline and one year ]A physical performance measure of combined trunk and arm endurance.
- Location of Vertebral Fractures [ Time Frame: Baseline and Month 12 ]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.
- Participant Weight [ Time Frame: Baseline and Month 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761084
|University of Waterloo|
|Waterloo, Ontario, Canada, N2L 3G1|
|Principal Investigator:||Lora Giangregorio, PhD||University of Waterloo|