Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD

NCT05048979 | Active Not Recruiting

• 1 other identifier: CDX 21-006
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At 3-months

• 30-sec-chair stands

  Measured in number of repetitions. This outcome will be evaluated at the 3-month mark.

  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.

  At 3-months.

Study Arms (2)

Exercise

EXPERIMENTAL

Prospective pre-post pilot study design. (N=54)

Other: Exercise

No exercise

NO INTERVENTION

Prospective cohort study design. (N=100)

Interventions

Exercise OTHER

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.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \[and presence of claudication, defined as fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently induced by exercise and consistently relieved by rest within 10 minutes.\]
• In addition, participants will require access to cellular signal at place of residence and/or exercise location

You may not qualify if:

• major lower extremity amputation
• critical limb ischemia
• inability to ambulate without a walker or wheelchair
• significant visual or hearing impairment
• individuals whose function is limited by severe conditions such as severe ischemic heart disease or \> Class II NYHA heart failure
• individuals capable of ambulating at a level comparable to the amount of exercise to be prescribed at baseline
• individuals currently enrolled in another exercise trial or cardiac rehab program
• individuals with uncontrolled psychiatric illness or dementia
• categorically vulnerable
• pregnant women, prisoners, children, or persons who lack decision-making capacity

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jorge Antonio Gutierrez, MD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Enrollment in a 12-week, 3 day a week, aerobic training program in a self-selected location. The exercise training will be via telehealth. Arm 1 will receive aforementioned intervention. Arm 2 will received no intervention.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 17, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)