Clinical trial NCT05048979: Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD
Official title: Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD (CDA 20-073)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-09-17
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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:

* Justification for exclusion criteria centers on inability to safely participate in the remote intervention. Specific exclusion criteria includes the following:
* 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

Primary outcomes:
measure: 6-minute walk test
timeFrame: At 3-months
measure: Walking impairment Questionnaire (WIQ)
timeFrame: At 3-months
measure: Vascular quality of life questionnaire (VascuQol)
timeFrame: At 3-months
measure: Flourish measure
timeFrame: At 3-months
measure: Claudication onset time
timeFrame: At 3-months
measure: Peak walking time
timeFrame: At 3-months
measure: 10 meter walk
timeFrame: At 3-months
measure: Balance test
timeFrame: At 3-months
measure: 30-sec arm curls
timeFrame: At 3-months
measure: 30-sec-chair stands
timeFrame: At 3-months
measure: 8 feet get up and go walk
timeFrame: At 3-months.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Jorge Antonio Gutierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: