Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02007525|
Recruitment Status : Terminated (Insufficient enrollment; non-interest by target sample)
First Posted : December 11, 2013
Last Update Posted : December 14, 2015
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.
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.
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease||Behavioral: Yoga intervention|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease: A Pilot Study|
|Study Start Date :||February 2013|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
|Experimental: Yoga intervention||
Behavioral: 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.
|No Intervention: Wait list control|
- 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). [ Time Frame: After 6 weeks ]
- To test the feasibility of a yoga program for patients with PAD. [ Time Frame: At end of study ]Feasibility will be determined by numbers of potential participants approached, and those who consent to participate vs. those who do not.
- To test the effectiveness of a yoga program to improve maximal walking distance among participants with PAD. [ Time Frame: Baseline and 6 weeks ]
- To test the effectiveness of a yoga program to reduce claudication symptoms among participants with PAD. [ Time Frame: Baseline and 6 weeks ]
- To test the effectiveness of a yoga program to improve health-related quality of life among participants with PAD. [ Time Frame: Baseline and 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007525
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Elizabeth A. Jackson, MD MPH FACC||University of Michigan|