Clinical trial NCT02007525: Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease
Official title: Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 7
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: After 6 weeks
Secondary outcomes:
measure: To test the feasibility of a yoga program for patients with PAD.
timeFrame: At end of study
measure: To test the effectiveness of a yoga program to improve maximal walking distance among participants with PAD.
timeFrame: Baseline and 6 weeks
measure: To test the effectiveness of a yoga program to reduce claudication symptoms among participants with PAD.
timeFrame: Baseline and 6 weeks
measure: To test the effectiveness of a yoga program to improve health-related quality of life among participants with PAD.
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elizabeth A. Jackson, MD MPH FACC
role: PRINCIPAL_INVESTIGATOR
References: