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NCT02007525 · ClinicalTrials.gov registry record · NA
Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease
A NA study, sponsored by University of Michigan.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT02007525 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 7 participants.
The verdict
NCT02007525, a NA study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study 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 ran
Interventions
- BEHAVIORAL Yoga intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02007525
The ClinicalTrials.gov registry entry for NCT02007525 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Yoga intervention is the first listed.
NCT02007525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02007525 about?
NCT02007525 is a clinical study titled "Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease". 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 ...
What is the current status of trial NCT02007525?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2013-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02007525?
The interventions under investigation include: Yoga intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02007525?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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