Post-osteoporotic Fracture Exercise Program

ConditionsOsteoporosis Osteoporotic Fracture

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorWestern University, Canada

About this trial

Those with osteoporosis often have weaker bones and this leads to higher chances of fractures. Therefore, the investigators want to evaluate the feasibility and safety of group exercise classes specifically designed for individuals with osteoporosis who had an osteoporotic fracture. By focusing on this high-risk population, the investigators want to see whether such exercise interventions can be an option for improving bone health, reducing the risk of future fractures, and enhancing physical function without compromising safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with osteoporosis.

History of low trauma fracture within the past year

Cleared for physical activity using the get active questionnaire, 100 bpm resting heart rate or less, 160 mm Hg diastolic blood pressure or less

Able to understand and provide informed consent.

Disqualifiers

Individuals who do not understand the English language

Medical conditions contraindicating participation in exercise (e.g., uncontrolled cardiovascular disease, severe respiratory illness).

Cognitive impairments that prevent informed consent or participation.

Recent major surgeries or medical events limiting physical activity.

Trial design

Design model

Single group

Treatments tested in this trial

Exercise Program
Other intervention
Participants complete a 12-week, twice weekly, whole body group exercise program. Participants will also complete qualitative interviews and DXA bone scans.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Experimental Arm for Feasibility studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Recruitment Feasibility

Recruitment feasibility will be assessed by the number of participants enrolled in the study over a 12-month recruitment period. The target recruitment goal is 100 participants.

Time frame

Assessed over 12 months

Retention Feasibility

Retention feasibility will be assessed as the percentage of enrolled participants who complete the 12-week reassessment. The predefined retention target is 60%. Percentages range from 0% to 100%, with higher percentages indicating better retention feasibility.

Time frame

Assessed at 12 weeks

Exercise Class Adherence

Exercise adherence will be assessed using class attendance records. Adherence will be calculated as the percentage of scheduled exercise sessions attended by each participant. The predefined adherence target is 80%. Percentages range from 0% to 100%, with higher percentages indicating better adherence.

Time frame

Assessed over the 12-week intervention period

Secondary outcomes

Program Acceptability

Program acceptability will be assessed using participant exit interviews conducted at the completion of the intervention. Acceptability will be calculated as the percentage of participants who report a positive response regarding satisfaction with the program. The predefined acceptability target is 80%. Percentages range from 0% to 100%, with higher percentages indicating greater program acceptability.

Time frame

Assessed at 12 weeks

Intervention Safety

Intervention safety will be assessed by recording the number and type of adverse events attributable to the intervention, including falls, musculoskeletal pain, prolonged muscle soreness, dizziness, fainting, shortness of breath, and other participant-reported medical concerns. Lower numbers indicate better intervention safety.

Time frame

Assessed throughout the 12-week intervention period

Other outcomes

Change in Bone Quality

Bone quality will be assessed using dual-energy X-ray absorptiometry (DXA), including Trabecular Bone Score assessment of bone microarchitecture. Higher bone mineral density and Trabecular Bone Score values indicate better bone health and bone microarchitecture.

Time frame

Baseline and 12 weeks

Change in health care utilization

Health care utilization will be assessed using Institute for Clinical Evaluative Sciences (ICES) health administrative records. Measures of health care utilization may include health care visits, hospitalizations, and fracture-related health service use following participation in the exercise program. Lower health care utilization and fewer fracture-related events may indicate improved health outcomes.

Time frame

Assessed over the 6-month period following completion of the exercise program

Change in Physical Function

Physical function will be assessed using the Short Physical Performance Battery. Scores range from 0 to 12, with higher scores indicating better lower extremity physical function.

Time frame

Baseline, 6 weeks, and 12 weeks

Change in Functional Exercise Capacity

Functional exercise capacity will be assessed using the 6-Minute Walk Test. Distance will be measured in meters, with greater distances indicating better functional exercise capacity.

Time frame

Baseline, 6 weeks, and 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western University, Canada

Lead sponsor

Source ClinicalTrials.gov

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