Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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The investigators propose to pilot test a six-week yoga program among adults with peripheral arterial disease (PAD). Participants (n=50) will be randomized to a six-week yoga intervention (n=25) or wait-list control (n=25). The yoga intervention will include a weekly yoga class currently used among cardiac rehab patients at the University of Michigan Health System, together with home-based practice sessions. Participants will perform treadmill testing at baseline and 6 weeks to assess walking capacity. The primary outcomes of interest include 1) acceptability of the program by participants, 2) feasibility of recruitment, 3) change in maximal walking distance, 4) change in claudication symptoms, and 5) change in health-related quality of life (HRQOL). The investigators expect this will inform us on the acceptability and feasibility of a larger proposal examining yoga in PAD patients. These data will also inform on the effect size in maximal walking, and HRQOL, which will be used to estimate the sample size needed for a larger R01 level proposal. Study hypotheses: Hypothesis 1: Participants will find the yoga program acceptable with low drop-out rates (<15%), excellent attendance (>80% classes attended), and good completion of the home-based practice sessions (self-report >80% completed). Hypothesis 2: The yoga intervention will be feasible for a larger study based on numbers of potential participants approached, and those who consent to participate vs. those who do not. Hypothesis 3: Increases in maximal walking distance and pain-free walking distance (from baseline to 6 weeks) will be greater in the participants randomized to the yoga intervention compared to the control group. Hypothesis 4: Self-reported claudication symptoms will be reduced to a greater degree (at 6 weeks) among participants randomized to the yoga intervention compared to the control group. Hypothesis 5: Increases in HRQOL (from baseline to 6 weeks) will be greater in the participants randomized to the yoga intervention compared to the control group.

Official Title
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Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease: A Pilot Study

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Behavioral: Yoga intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 40 Diagnosis of lower extremity PAD (defined as a documented ankle-brachial index of < 0.9) Do less than 150 minutes of exercise per week Competent to give informed consent Exclusion Criteria: Life expectancy under 1 year Pregnancy Co-morbidities which limit physical activity to a severe degree (unable to walk at least a block) Signs of critical limb ischemia and/or planned revascularization in the next 12-months Recent CVD event (< 3 months) including stroke/transient ischemic attack (TIA), myocardial infarction (MI), unstable angina (UA), percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG), or severe valve disease, congenital heart disease, complex arrhythmias (untreated), NYHA class III-IV heart failure Recent or current enrollment in formal exercise or yoga program Psychiatric disorder, which limits subjects ability to follow the study protocol Current substance abuse Non-English speaking

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga intervention<br> | Behavioral: Yoga intervention<br>* Participants will attend one weekly 60 minute hatha yoga class taught by a certified yoga instructor for 6 weeks. Each participant is to practice yoga at home 3-5 days per week. Paper logs will be provided to record date, time and duration of yoga practice each week.<br>|
| No Intervention: Wait list control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the acceptability of a yoga program for patients with PAD. We will evaluate drop-out rates (<15%), attendance (>80% classes attended), and completion of the home-based practices sessions (self-report >80% completed). |  | After 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the feasibility of a yoga program for patients with PAD. | Feasibility will be determined by numbers of potential participants approached, and those who consent to participate vs. those who do not. | At end of study | 
| To test the effectiveness of a yoga program to improve maximal walking distance among participants with PAD. |  | Baseline and 6 weeks | 
| To test the effectiveness of a yoga program to reduce claudication symptoms among participants with PAD. |  | Baseline and 6 weeks | 
| To test the effectiveness of a yoga program to improve health-related quality of life among participants with PAD. |  | Baseline and 6 weeks |