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Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD (MOVE-IT)

Primary Purpose

Peripheral Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
  • above or below the knee 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

Sites / Locations

  • Durham VA Medical Center, Durham, NCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

No exercise

Arm Description

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

Prospective cohort study design. (N=100)

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
10 meter walk
Time it takes subject to walk 10 meters. Measured in seconds. This outcome will be evaluated at the 3-month mark.
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.
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.
30-sec-chair stands
Measured in number of repetitions. This outcome will be evaluated at the 3-month mark.
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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2021
Last Updated
October 4, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05048979
Brief Title
Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD
Acronym
MOVE-IT
Official Title
Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD (CDA 20-073)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: To develop a telehealth-facilitated exercise intervention for Veterans with PAD that serves as a Veteran centric new model of care. To integrate Veteran preferences into the development of a telehealth-facilitated supervised exercise program. To assess the long-term patterns of functional impairment and quality of life among Veterans with PAD not undergoing supervised exercise training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Prospective pre-post pilot study design. (N=54)
Arm Title
No exercise
Arm Type
No Intervention
Arm Description
Prospective cohort study design. (N=100)
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-minute walk test
Description
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
Title
Walking impairment Questionnaire (WIQ)
Description
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
Title
Vascular quality of life questionnaire (VascuQol)
Description
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
Title
Flourish measure
Description
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
Title
Claudication onset time
Description
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
Title
Peak walking time
Description
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
Title
10 meter walk
Description
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
Title
Balance test
Description
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
Title
30-sec arm curls
Description
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
Title
30-sec-chair stands
Description
Measured in number of repetitions. This outcome will be evaluated at the 3-month mark.
Time Frame
At 3-months
Title
8 feet get up and go walk
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge A Gutierrez, MD
Phone
(919) 286-0411
Email
jorgeantonio.gutierrez@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Antonio Gutierrez, MD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurel B Koss, MS OTR
Phone
(919) 286-0411
Ext
775648
Email
laurel.koss@va.gov
First Name & Middle Initial & Last Name & Degree
Jorge Antonio Gutierrez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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