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

NCT ID: NCT02007525

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Yoga intervention

Group Type: EXPERIMENTAL

Yoga intervention

Intervention Type: BEHAVIORAL

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.

Wait list control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Yoga intervention

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth A. Jackson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A. Jackson, MD MPH FACC

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

321872

Identifier Type: -

Identifier Source: org_study_id