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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL115534 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
The investigators will test the hypothesis that PAD patients randomized to the exercise program in the community setting incorporating TMC+ will improve walking ability compared with patients who receive the standard of care (exercise advice). Secondary hypotheses include a significant improvement in patient-reported outcomes, an improvement in functional ability or a significant increase in volume of physical activity for patients who complete community-based walking exercise when compared with patients receiving the standard of care. Exploratory hypotheses include a significant improvement in PWT for 1) patients receiving a combination of lower extremity endovascular therapy (ET) and community-based walking exercise or 2) open peripheral intervention and community-based walking exercise compared to patients who do not receive endovascular therapy or open intervention and receive only the standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise therapy | Experimental | Claudication, no peripheral revasc |
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| Exercise advice | Placebo Comparator | Claudication, no peripheral revasc |
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| lower extremity ET, exercise therapy | Experimental |
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| lower extremity ET, exercise advice | Placebo Comparator |
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| Peripheral open intervention, exercise therapy | Experimental |
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| Peripheral open intervention, exercise advice | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise therapy | Behavioral | The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak walking time (PWT) | Baseline, post-revascularization (ET or open intervention) (4 weeks, if applicable), post-12 weeks (exercise and control groups), 6 months following intervention time period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in claudication onset time (COT) | Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period | |
| Change in patient-reported outcomes | Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan J. Mays, PhD, MPH, MS | International Heart Institute of Montana Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Heart Institute of Montana Foundation | Missoula | Montana | 59802 | United States |
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| Label | URL |
|---|---|
| Click here for more information about the sponsor. | View source |
| Click here for more information about the sponsor. | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2019 | Apr 20, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| lower extremity ET | Procedure | catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital) |
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| peripheral open intervention | Procedure | revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital) |
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| Change in peak oxygen uptake | Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period |
| Change in functional ability | Functional ability will be assessed with the 6-min walk test and Short Physical Performance Battery which consists of 1) walking short distances, 2) completing balance tests and 3) sit and standing from a chair 5 times. | Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period |
| Evaluation of total volume of activity | post-12 weeks (exercise and control groups) |
| Evaluation of exercise adherence | For patients randomized to the exercise therapy group | post-12 weeks (exercise and control groups) |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |