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Remote Monitoring of Home Exercise in Peripheral Arterial Disease (ROMEPAD)

Primary Purpose

Peripheral Arterial Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Provider supervision/ feedback

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring PAD, Home walking, Remote monitoring, Claudication

Eligibility Criteria

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

Inclusion Criteria:

Age >18
Diagnosis of PAD (based on ABI <0.9 in either leg or prior intervention) with mild/moderate claudication

Exclusion Criteria:

Prior above ankle amputation
Wheelchair bound
Inability to walk >200m during 6 min walk test
Use of walking aid other than cane
Walking impairment for reason other than PAD
Critical limb ischemia
Planned vascular surgery within next 3 months, recent surgery within past 3 months

Sites / Locations

Dallas North Texas Veterans Affairs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Provider Supervised

Self Supervised

Arm Description

Digital monitoring system with provider supervision

Digital monitoring system without provider supervision

Outcomes

Primary Outcome Measures

Change in 6 minute walk test distance between groups

Secondary Outcome Measures

Change in Walking Impairment Questionnaire score

Change in Walking Impairment Questionnaire score between groups

Change in VascuQOL-6 (VQ6) quality of life survey

Change in VascuQOL-6 (VQ6) quality of life survey between groups

Full Information

NCT ID

NCT05209724

First Posted

January 13, 2022

Last Updated

January 13, 2022

Sponsor

Dallas VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05209724

Brief Title

Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Acronym

ROMEPAD

Official Title

Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 21, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dallas VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Many patients with blockages in the arteries in their legs (peripheral arterial disease, "PAD") suffer from pain in their legs when walking. Exercise therapy is known to decrease pain levels as well as increase the distance that patients with PAD can walk. The purpose of this study is to understand whether home exercise using a digital exercise monitoring system (LIVMOR) with provider supervision/ feedback will improve walking distance compared to those undergoing home exercise using the same monitoring system but without provider supervision/ feedback.

6. Conditions and Keywords

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

Peripheral Arterial Disease

Keywords

PAD, Home walking, Remote monitoring, Claudication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Provider Supervised

Arm Type

Experimental

Arm Description

Digital monitoring system with provider supervision

Arm Title

Self Supervised

Arm Type

No Intervention

Arm Description

Digital monitoring system without provider supervision

Intervention Type

Behavioral

Intervention Name(s)

Provider supervision/ feedback

Intervention Description

Provider supervision/ feedback provided before and after walking sessions

Primary Outcome Measure Information:

Title

Change in 6 minute walk test distance between groups

Description

Change in 6 minute walk test distance between groups

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Walking Impairment Questionnaire score

Description

Change in Walking Impairment Questionnaire score between groups

Time Frame

12 weeks

Title

Change in VascuQOL-6 (VQ6) quality of life survey

Description

Change in VascuQOL-6 (VQ6) quality of life survey between groups

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >18 Diagnosis of PAD (based on ABI <0.9 in either leg or prior intervention) with mild/moderate claudication Exclusion Criteria: Prior above ankle amputation Wheelchair bound Inability to walk >200m during 6 min walk test Use of walking aid other than cane Walking impairment for reason other than PAD Critical limb ischemia Planned vascular surgery within next 3 months, recent surgery within past 3 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

McCall Walker, MD

Phone

985-381-6661

mccall.walker@phhs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Subhash Banerjee, MD, MBA

Organizational Affiliation

Dallas VA Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dallas North Texas Veterans Affairs Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristina Sanchez

Phone

214-857-3048

cristina.sanchez@va.gov

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No IPD are to be shared.

Learn more about this trial

Remote Monitoring of Home Exercise in Peripheral Arterial Disease

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