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The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Rehabilitation Group | Experimental | Participants randomized to this group will undergo cardiac rehabilitation program. |
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| Control Group | Active Comparator | Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Rehabilitation Program | Other | Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months. Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 minute walk test | Results will be measured in meters. | Change from Baseline to Up to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Health Survey 36 (SF-36) | Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability. | Change from Baseline to Up to 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Gupta, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Conventional Therapy | Other | Participants will be asked to complete tests and questionnaires that would normally be done for their condition. |
|
| Short Form Health Survey 36 (SF-36) |
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability. |
| Change from Baseline to Week 18 |
| Vascular Quality of Life Questionnaire-6 (VascuQol6) | The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status. | Change from Baseline to Up to 6 Months |
| Vascular Quality of Life Questionnaire-6 (VascuQol6) | The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status. | Change from Baseline to Week 18 |
| Absolute Claudication Distance (ACD) | ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters | Change from Baseline to Up to 6 Months |
| Functional Claudication Distance (FCD) | FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters. | Change from Baseline to Up to 6 Months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |