Overview

This trial is active, not recruiting.

Conditions osteoporotic fractures, spinal fractures
Treatment exercise and behaviour change strategies
Sponsor University of Waterloo
Collaborator Canadian Institutes of Health Research (CIHR)
Start date January 2013
End date December 2016
Trial size 139 participants
Trial identifier NCT01761084, 18539

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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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
cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) perform muscle strengthening and balance training exercises ≥ 3 days a week 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.
(No Intervention)
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.

Primary Outcomes

Measure
Feasibility of recruitment and retention
time frame: Monthly records up to 12 months.
Adherence
time frame: Monthly records over 12 months

Secondary Outcomes

Measure
Number and location of fractures.
time frame: Baseline, one year and at report of fracture (monitored monthly for reports).
Number of falls.
time frame: Monthly up to one year.
Occiput to wall distance
time frame: Baseline and one year.
Scores on the Short Physical Performance Battery (SPPB)
time frame: Baseline and one year.
Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
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.
Score on Short-form Falls Efficacy Scale International (FES-I).
time frame: Baseline, 6 months and one year.
Productivity
time frame: Monthly up to one year.
Physical activity
time frame: Baseline, 6 months, 12 months
Number of adverse events per participant.
time frame: Monthly up to one year.
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 and weight
time frame: Baseline and one year
Activities of Daily Living
time frame: Monthly up to one year
Timed Loaded Standing Test
time frame: Baseline and one year

Eligibility Criteria

Female participants at least 65 years old.

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

Additional Information

Official title Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture
Principal investigator Lora Giangregorio, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Waterloo.