An interventional study of Exercise in Peripheral Artery Disease, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The present study aims to increase Veteran access to supervised exercise therapy and expand its role in improving functional status, quality of life, and cardiovascular risk profile of Veterans with PAD.
The investigators will use the VA Telehealth service to deploy a remotely accessible supervised exercise training program and evaluate whether a telehealth-based intervention can improve walking performance, quality of life, and ultimately cardiac risk in Veterans with PAD. The impetus for the current proposal stems from the following: 1) over 50% of VA-enrolled Veterans live in rural communities; 2) Veterans with PAD are older (mean age, 70 years), further increasing their risk for functional decline; and 3) there is a significant lack of access to facility-based supervised exercise training for Veterans with PAD. The objectives include the following:
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 73 is close to the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of PAD, defined as a history of an ankle-brachial index (ABI) of 0.90, prior revascularization of a lower limb for symptomatic disease more than 30 days prior to presentation, or ABI >0.90 with evidence of PAD based on noninvasive vascular laboratory testing or angiography
Exclusion Criteria:
categorically vulnerable
Prospective pre-post pilot study design. (N=54)
Other: Exercise
Prospective cohort study design. (N=100)
Telehealth-facilitated supervised exercise program. Veterans with PAD will be enrolled in a 12-week, 3 day a week, aerobic training program in a self-selected location.
6-minute walk test
Participants will be asked to walk in an unobstructed 100-ft hall for 6 continuous minutes with the goal of walking the greatest distance possible. Participants are allowed to stop and rest (standing or sitting), but the stopwatch will continue to run. The key outcome is distance walked. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
Walking impairment Questionnaire (WIQ)
Will evaluate the following: 1) symptoms while walking (typical and atypical); 2) perceived difficulty walking defined distances (ranging from walking indoors to 1,500 feet or 5 blocks); 3) and perceived difficulty walking defined speeds; and 4) ability to climb stairs. Assessments are made on a graded scale from 0 to 4. A difficulty score a 0 represents very difficult and 4 represents no difficulty. The graded scores are multiplied by prespecified weights for each distance, speed, or number of flights of stairs. The products are then summed and divided by the maximum possible score ranging from 0 (inability to perform the task) to 100 (no difficulty performing the task). This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
Vascular quality of life questionnaire (VascuQol)
The Vascular Quality of Life Questionnaire (VascuQol) is a PAD specific and commonly used health related quality of life questionnaire with positive responsiveness correlated to both clinical improvement and deterioration on short and long term follow-up subsequent to treatment interventions. The VascuQol consists of items that span five domains (pain, symptoms, activities, emotional, and social). Each item is scored on a seven-point rating scale, where 1 represents the worst and 7 the best possible score. A sum score is calculated by dividing the sum all items by 25. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
Flourish measure
The Flourish Measure is a composite evaluation of human well-being with excellent viability, and applicability in both community and workplace. The Flourish Measure consists of 12 questions that span 6 domains (happiness and life satisfaction, mental and physical health, meaning and purpose, character and virtue, close social relationships, financial and material stability). Each item is scored on an eleven-point rating scale of 0-10 with higher scores indicating favorable responses. Scores are calculated by summing the scores of all six domains. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
Claudication onset time
The walking time at which the subjects first experienced lower extremity pain. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
Peak walking time
Walking time at which ambulation cannot continue due to maximal lower extremity pain. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
10 meter walk
Time it takes subject to walk 10 meters. Measured in seconds. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
Balance test
Subject balance evaluated by having them stand with feet side-by-side, semi-tandem, and then tandem. For each stance outcome is measures as yes or no. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
30-sec arm curls
Measured in number of repetitions (8 pound weight for men and 5 pound weight for women). This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
30-sec-chair stands
Measured in number of repetitions. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months
8 feet get up and go walk
Time it takes to go from sitting to standing and walking 8 feet. Measured in seconds. This outcome will be evaluated at the 3-month mark.
Time frame: At 3-months.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development