Clinical trial NCT01761084: Build Better Bones With Exercise
Official title: Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporotic Fractures
Spinal Fractures
Keywords: Osteoporosis
Spine fracture
Vertebral fracture
Exercise Interventions
Exercise
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Western Ontario, Canada
name: University Health Network, Toronto
name: McMaster University
name: University of Melbourne
name: University of British Columbia
First posted: 2013-01-04
Enrollment: 141
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Recruitment and Retention
timeFrame: Monthly records up to 12 months.
measure: Adherence
timeFrame: Monthly records over 12 months
Secondary outcomes:
measure: Number of Fractures.
timeFrame: Baseline, one year and at report of fracture (monitored monthly for reports).
measure: Number of Fallers
timeFrame: Monthly up to one year.
measure: Occiput to Wall Distance
timeFrame: Baseline and one year.
measure: Scores on the Short Physical Performance Battery (SPPB)
timeFrame: Baseline and one year.
measure: Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
timeFrame: Baseline and one year.
measure: 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).
timeFrame: Baseline, 6 months and one year.
measure: Scores on Exercise Self-efficacy Scales.
timeFrame: Baseline, 6 months and one year.
measure: Score on Short-form Falls Efficacy Scale International (FES-I).
timeFrame: Baseline, 6 months and one year.
measure: Productivity
timeFrame: Monthly up to one year.
measure: Physical Activity
timeFrame: Baseline, 6 months, 12 months
measure: Number of Serious Adverse Events.
timeFrame: Monthly up to one year.
measure: Number of Individuals Screened and Eligible Per Collection Site.
timeFrame: over the course of the study (2.29 years)
measure: Number of Potentially Eligible Males
timeFrame: over recruitment period
measure: Number of Participants With Multiple Falls
timeFrame: Monthly up to 12 months.
measure: Total Number of Falls
timeFrame: Monthly up to 12 months.
measure: Value of Direct Medical Resources Per Participant.
timeFrame: Accrued costs over 12 months
measure: Value of Non-direct Medical Resources Per Participant.
timeFrame: Accrued costs over 12 months
measure: Participant Height
timeFrame: Baseline and one year
measure: Activities of Daily Living
timeFrame: Monthly up to one year
measure: Timed Loaded Standing Test
timeFrame: Baseline and one year
measure: Location of Vertebral Fractures
timeFrame: Baseline and Month 12
measure: Participant Weight
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lora Giangregorio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibbs JC, McArthur C, Wark JD, Thabane L, Scherer SC, Prasad S, Papaioannou A, Mittmann N, Laprade J, Kim S, Khan A, Kendler DL, Hill KD, Cheung AM, Bleakney R, Ashe MC, Adachi JD, Giangregorio LM. The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial. Phys Ther. 2020 Apr 17;100(4):662-676. doi: 10.1093/ptj/pzz188.
citation: 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.