- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07595991
Post-osteoporotic Fracture Exercise Program
May 12, 2026 updated by: Christina Ziebart, Western University, Canada
Community Osteoporosis Exercise Class for People Post Fracture
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Ziebart, PT, PhD
- Phone Number: 88850 519-661-2111
- Email: cziebart@uwo.ca
Study Contact Backup
- Name: Abigail Mitchell, BSc
- Phone Number: 709-727-2762
- Email: amitc57@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6G 1H1
- Canadian Centre for Activity and Aging
-
Contact:
- Christina Ziebart, PT, PhD
- Phone Number: 88850 519-661-2111
- Email: cziebart@uwo.ca
-
Contact:
- Steve Di Ciacca, MSc, BSc(PT), BHKin
- Phone Number: 81609 519 661-1603
- Email: sdiciacc@uwo.ca
-
Principal Investigator:
- Christina Ziebart, PT, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Arm for Feasibility study
Feasibility Intervention
|
Participants complete a 12-week, twice weekly, whole body group exercise program.
Participants will also complete qualitative interviews and DXA bone scans.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Assessed over 12 months
|
|
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.
|
Assessed at 12 weeks
|
|
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.
|
Assessed over the 12-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Assessed at 12 weeks
|
|
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.
|
Assessed throughout the 12-week intervention period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 12 weeks
|
|
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.
|
Assessed over the 6-month period following completion of the exercise program
|
|
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.
|
Baseline, 6 weeks, and 12 weeks
|
|
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.
|
Baseline, 6 weeks, and 12 weeks
|
|
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.
|
Baseline, 6 weeks, and 12 weeks
|
|
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.
|
Baseline, 6 weeks, and 12 weeks
|
|
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.
|
Baseline, 6 weeks, 12 weeks, and 6 months
|
|
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.
|
Baseline, 6 weeks, 12 weeks, and 6 months
|
|
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.
|
Baseline, 6 weeks, 12 weeks, and 6 months
|
|
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.
|
Baseline, 6 weeks, and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
February 1, 2028
Study Registration Dates
First Submitted
April 28, 2026
First Submitted That Met QC Criteria
May 12, 2026
First Posted (Actual)
May 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Wounds and Injuries
- Metabolic Diseases
- Fractures, Bone
- Bone Diseases, Metabolic
- Nutritional and Metabolic Diseases
- Osteoporosis
- Osteoporotic Fractures
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- 127410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Sharing of individual participant data will be upon request and only deidentified data will be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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