Build Better Bones With Exercise

NCT01761084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2019-11-14

Study results available
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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%.

Conditions

  • Osteoporotic Fractures
  • Spinal Fractures

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • University of Western Ontario, Canada

    collaborator OTHER
  • University Health Network, Toronto

    collaborator OTHER
  • McMaster University

    collaborator OTHER
  • University of Melbourne

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • University of Waterloo

    lead OTHER

Principal Investigators

  • Lora Giangregorio, PhD · University of Waterloo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01761084 on ClinicalTrials.gov