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Build Better Bones With Exercise (B3E)

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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

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Results First Submitted Date  ICMJE May 9, 2018
Results First Posted Date  ICMJE November 14, 2019
Last Update Posted Date November 14, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Feasibility [ Time Frame: Monthly records up to 12 months. ]
Number of exercise sessions completed relative to prescribed. We will use a calendar for participants to self-report adherence. Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • Number and location 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 falls. [ Time Frame: Monthly up to one year. ]
    We will use a falls calendar for participants to self-report falls.
  • Occiput to Wall Distance [ Time Frame: Baseline and one year. ]
  • Average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test). [ Time Frame: Baseline and one year. ]
  • 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. We will also look at changes in these outcomes individually.
  • Gait speed during 4-meter walk test. [ Time Frame: Baseline and one year. ]
  • 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. [ Time Frame: Baseline, 6 months and one year. ]
  • Scores on Exercise Self-efficacy Scales. [ Time Frame: Baseline, 6 months and one year. ]
    To assess self-efficacy related to engaging in exercise, patients will be asked "Over the next 3 months, how confident are you to participate in an exercise program for 30 minutes for at least 3 days per week". To assess implementation intentions, patients are asked "Do you have a plan to start an exercise program at least 3 times a week for the next 3 months". Patients will rate their answers on a scale from 1-5 or 1-10.
  • Score on Short-form Falls Efficacy Scale International (FES-I). [ Time Frame: Baseline, 6 months and one year. ]
  • Workplace Productivity and Activity Index. [ Time Frame: Baseline, 6 months and one year. ]
  • Total physical activity [ Time Frame: Baseline, 6 months, 12 months ]
    Estimated as the average minutes reported on an activity log at baseline and during the two weeks prior to assessments. A subset of participants will wear an accelerometer for 7 days at baseline and follow-up.
  • Number of adverse events per participant. [ 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 1 year ]
  • Number of Potentially Eligible Males [ Time Frame: over 1 year of recruitment ]
  • Number of multiple fallers. [ Time Frame: Monthly up to 12 months. ]
  • Falls rate. [ Time Frame: Monthly up to 12 months. ]
  • Value of Direct Medical Resources Per Participant. [ Time Frame: Baseline, 6 months and one year. ]
  • Value of Non-direct Medical Resources Per Participant. [ Time Frame: Baseline, 6 months and one year. ]
  • Height [ Time Frame: Baseline and one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Build Better Bones With Exercise
Official Title  ICMJE Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture
Brief Summary The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.
Detailed Description There is limited data available from which to develop guidelines for safe and effective exercise prescription among individuals with hip or vertebral fractures. The long-term goal of our research team is to conduct a large multi-centre randomized controlled trial (RCT) to investigate whether participating in a thrice-weekly home exercise program for one year can reduce incident fragility fractures among women aged 65 years or older with a history of vertebral fracture compared to no intervention. The current study is a pilot study with the principal objective of determining the feasibility of recruitment, retention and adherence of an international multicentre RCT evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. The intervention was developed by experts in exercise prescription based on a rigorous literature review and Cochrane meta-analysis we have conducted. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. Secondary outcomes of the pilot study are those hypothesized to be among the causal pathway linking exercise to fracture risk, including lower extremity strength, posture, balance, as well as falls and fractures. Additional secondary outcomes include quality of life, pain, exercise self-efficacy, the cost of the intervention, and the risk of adverse events associated with exercise. The recruitment and retention process will be summarized using a CONSORT flow diagram, and the reporting of results will be in accordance with the CONSORT criteria. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to criteria defined a priori. Differences in secondary outcomes will be evaluated in intention to treat analyses via independent student T-tests, Chi Square or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall level is alpha=0.05. Even if the larger trial proves not to be feasible, the current trial will be one of the largest exercise studies among a representative group of women with vertebral fracture to date, and will evaluate the feasibility and costs of a comprehensive home exercise program, and its effect on important secondary outcomes. Osteoporosis Canada has defined a need to develop patient resources on exercise and recently announced a shift in priority to individuals with existing fractures; the proposed pilot study is timely and will directly inform these knowledge translation initiatives.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Osteoporotic Fractures
  • Spinal Fractures
Intervention  ICMJE Behavioral: Exercise and behaviour change strategies
  1. cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day
  2. postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily)
  3. perform muscle strengthening and balance training exercises ≥ 3 days a week
  4. 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.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
Publications * Giangregorio LM, Thabane L, Adachi JD, Ashe MC, Bleakney RR, Braun EA, Cheung AM, Fraser LA, Gibbs JC, Hill KD, Hodsman AB, Kendler DL, Mittmann N, Prasad S, Scherer SC, Wark JD, Papaioannou A. Build better bones with exercise: protocol for a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in women with a vertebral fracture. Phys Ther. 2014 Sep;94(9):1337-52. doi: 10.2522/ptj.20130625. Epub 2014 May 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2019)
141
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
160
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:

    • documented height loss of ≥2cm
    • historical height loss of ≥6cm
    • visible hyperkyphosis
  • age greater than or equal to 65 years of age
  • able to understand instructions in english
  • able to give informed consent (no cognitive impairment)

Exclusion Criteria:

  • Current or prior cancer
  • On dialysis, known liver, kidney or malabsorption disease
  • Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
  • Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
  • Uncontrolled hypertension or other contraindications to exercise
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761084
Other Study ID Numbers  ICMJE 18539
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Waterloo
Study Sponsor  ICMJE University of Waterloo
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • University of Western Ontario, Canada
  • University Health Network, Toronto
  • McMaster University
  • University of Melbourne
  • University of British Columbia
Investigators  ICMJE
Principal Investigator: Lora Giangregorio, PhD University of Waterloo
PRS Account University of Waterloo
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP