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RecruitingNCT07595991ClinicalTrials.gov record

Post-osteoporotic Fracture Exercise Program

Osteoporosis · Osteoporotic Fracture

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • 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.
  • Residing within the study's geographic area (e.g., London, Ontario).

Exclusion Criteria:

  • 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.
  • Participation in conflicting clinical trials or rehabilitation programs.
  • Residents outside the designated study area.
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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
Experimental Arm for Feasibility study

Feasibility Intervention

Other: Exercise Program

Exercise Program OTHER

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Recruitment Feasibility

Time frame: Assessed over 12 months

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.

Retention Feasibility

Time frame: Assessed at 12 weeks

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.

Exercise Class Adherence

Time frame: Assessed over the 12-week intervention period

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.

Secondary measures

Program Acceptability

Time frame: Assessed at 12 weeks

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.

Intervention Safety

Time frame: Assessed throughout the 12-week intervention period

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.

Other measures

Change in Bone Quality

Time frame: Baseline and 12 weeks

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.

Change in health care utilization

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

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.

Change in Physical Function

Time frame: Baseline, 6 weeks, and 12 weeks

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.

Change in Functional Exercise Capacity

Time frame: Baseline, 6 weeks, and 12 weeks

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.

Change in Mobility

Time frame: Baseline, 6 weeks, and 12 weeks

Mobility will be assessed using the Timed Up and Go Test. Time will be measured in seconds, with lower times indicating better mobility and lower fall risk.

Change in Single Leg Balance

Time frame: Baseline, 6 weeks, and 12 weeks

Static balance will be assessed using the Single Leg Balance Test. Time will be measured in seconds, with longer durations indicating better balance performance.

Change in Osteoporosis-Specific Quality of Life

Time frame: Baseline, 6 weeks, 12 weeks, and 6 months

Quality of life will be assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Scores range from 0 to 100, with lower scores indicating better quality of life.

Change in Overall Health-Related Quality of Life

Time frame: Baseline, 6 weeks, 12 weeks, and 6 months

Health-related quality of life will be assessed using the EuroQol 5 Dimension (EQ-5D). Scores range from less than 0 to 1, with higher scores indicating better health-related quality of life.

Change in Physical Activity

Time frame: Baseline, 6 weeks, 12 weeks, and 6 months

Physical activity participation will be assessed using the Physical Activity Scale for the Elderly. Scores range from 0 to over 400, with higher scores indicating greater physical activity participation.

Change in Grip Strength

Time frame: Baseline, 6 weeks, and 12 weeks

Grip strength will be assessed using hand dynamometry. Grip strength will be measured in kilograms, with higher values indicating greater grip strength and upper extremity muscle function.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (1)

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1 locations

Canadian Centre for Activity and AgingLondon, Ontario, CanadaRecruiting
Christina Ziebart, PT, PhDCONTACTcziebart@uwo.ca519-661-2111 88850
Steve Di Ciacca, MSc, BSc(PT), BHKinCONTACTsdiciacc@uwo.ca519 661-1603 81609
Christina Ziebart, PT, PhDPRINCIPAL_INVESTIGATOR
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Study team and timeline

Lead sponsor
Western University, Canada
Study start
2026-12 Estimated
Primary completion
2027-08 Estimated
Study completion
2028-02 Estimated
First posted
May 19, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Christina Ziebart, PT, PhDCONTACTcziebart@uwo.ca519-661-2111 88850
Abigail Mitchell, BScCONTACTamitc57@uwo.ca709-727-2762
Official study title

Community Osteoporosis Exercise Class for People Post Fracture

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026