Peripheral Arterial DiseaseNCT02007525
Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease
A study testing Yoga intervention in people with Peripheral Arterial Disease, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Yoga intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Psychiatric disorder, which limits subjects ability to follow the study protocol
- Current substance abuse
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease: A Pilot Study
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:
Read more
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
- Being tested
- Yoga intervention
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga intervention | Experimental | Not described Receives: Behavioral: Yoga intervention |
| Wait list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 6 weeks
Secondary outcomes (4)
To test the feasibility of a yoga program for patients with PAD.
Feasibility will be determined by numbers of potential participants approached, and those who consent to participate vs. those who do not.
Measured: At end of study
To test the effectiveness of a yoga program to improve maximal walking distance among participants with PAD.
Measured: Baseline and 6 weeks
To test the effectiveness of a yoga program to reduce claudication symptoms among participants with PAD.
Measured: Baseline and 6 weeks
To test the effectiveness of a yoga program to improve health-related quality of life among participants with PAD.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Insufficient enrollment; non-interest by target sample
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth A. Jackson, University of Michigan
- Investigators
- Elizabeth A. Jackson, MD MPH FACC, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007525
- Sponsor's protocol ID
- 321872
- Status last verified
- Dec 2015
- First submitted
- 22 Nov 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT02007525
- Acronym / sponsor ID
- 321872
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment; non-interest by target sample
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention | Experimental | Behavioral: Yoga intervention |
| Wait list control | No intervention | – |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga interventionParticipants 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. | Behavioural | Yoga intervention |
Primary outcome
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
4 secondary outcomes
To test the feasibility of a yoga program for patients with PAD.
Time frame: At end of study
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
Results and safety
The study was stopped early (reason given: Insufficient enrollment; non-interest by target sample). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A. Jackson, MD MPH FACC principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga intervention in people with Peripheral Arterial Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment; non-interest by target sample). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: After 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.