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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm for Feasibility study | Experimental | Feasibility Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Assessed over the 12-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Change in health care utilization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Ziebart, PT, PhD | Contact | 519-661-2111 | 88850 | cziebart@uwo.ca |
| Abigail Mitchell, BSc | Contact | 709-727-2762 | amitc57@uwo.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Centre for Activity and Aging | London | Ontario | N6G 1H1 | Canada |
Sharing of individual participant data will be upon request and only deidentified data will be shared
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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. | Assessed throughout the 12-week intervention period |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |