Trial record 16 of 229 for:    Open Studies | "Peripheral Arterial Disease"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Jackson, University of Michigan
ClinicalTrials.gov Identifier:
NCT02007525
First received: November 22, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Behavioral: Yoga intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To test the feasibility of a yoga program for patients with PAD. [ Time Frame: At end of study ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • To test the effectiveness of a yoga program to reduce claudication symptoms among participants with PAD. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007525

Contacts
Contact: Elizabeth A. Jackson, MD MPH FACC (734) 998-7411 lisjacks@med.umich.edu
Contact: Samantha Fink (734) 998-5668 smfink@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Principal Investigator: Elizabeth A. Jackson, MD MPH FACC         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Elizabeth A. Jackson, MD MPH FACC University of Michigan
  More Information

No publications provided

Responsible Party: Elizabeth A. Jackson, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02007525     History of Changes
Other Study ID Numbers: 321872
Study First Received: November 22, 2013
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014