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

NCT ID: NCT05048979

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

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. To develop a telehealth-facilitated exercise intervention for Veterans with PAD that serves as a Veteran centric new model of care.

2. To integrate Veteran preferences into the development of a telehealth-facilitated supervised exercise program.

3. To assess the long-term patterns of functional impairment and quality of life among Veterans with PAD not undergoing supervised exercise training.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

No exercise

Prospective cohort study design. (N=100)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Antonio Gutierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

Other Identifiers

CDX 21-006

Identifier Type: -

Identifier Source: org_study_id