Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 41 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | December 2015 |
Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease: A Pilot Study
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.
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.
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
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