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| Name | Class |
|---|---|
| Carnegie Mellon University | OTHER |
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This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.
Participants will be randomly assigned to 1 of 2 treatment groups. Both groups do the same exercise program 3 times a week for 12 weeks on nonconsecutive days. The only difference is that one group will perform the exercises with small resting periods between exercises as normally done in clinical practice. The other group will have two long rests of 45 minutes during the exercise training session. Before and after the exercise programs, participants will undergo a series of assessments including gait analysis, MRI imaging of knees, tests of muscle strength and physical performance. Questionnaires will be completed. Blood and synovial fluid will be collected as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise With Rest | Experimental | Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours. |
|
| Exercise Without Rest | Active Comparator | Exercise without Rest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise with Rest | Behavioral | Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment | The number of eligible individuals who are randomized out of all eligible individuals. | The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of interventions | The number of adverse events related to study participation in each arm | 3 months (window of 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Intervention | The number of intervention sessions attended out of the total number of intervention sessions prescribed in the study. | 3 months (window of 1 month) |
| Study retention | The number of participants in each intervention arm who attend the follow-up assessment visit out of the number of participants randomized to each intervention arm. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaupp | Contact | 412-383-0742 | awg26@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sara Piva | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
The data supporting the conclusions of this study will be available upon request to the principal investigators. The data will include participants demographic and biomedical information, along with primary and secondary outcome measures. The data dictionary will be provided.
The data will be available at the time of the publication of the pilot feasibility results in peer-reviewed medical journal.
IPD will be available upon request to the principal investigators. The data will include participants demographic and biomedical information, along with primary and secondary outcome measures. The data dictionary will be provided. Non-identifiable data will be shared in CSV files.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C092779 | RE1-silencing transcription factor |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise without Rest | Behavioral | Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include minimal resting periods between exercises and take about one hour. |
|
| 3 months (window of 1 month) |
| D001519 |
| Behavior |