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

January 13, 2022 updated by: Subhash Banerjee, Dallas VA Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Recruiting
        • Dallas North Texas Veterans Affairs Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Provider Supervised
Digital monitoring system with provider supervision
Behavioral: Provider supervision/ feedback
Provider supervision/ feedback provided before and after walking sessions
NO_INTERVENTION: Self Supervised
Digital monitoring system without provider supervision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6 minute walk test distance between groups
Time Frame: 12 weeks
Change in 6 minute walk test distance between groups
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Walking Impairment Questionnaire score
Time Frame: 12 weeks
Change in Walking Impairment Questionnaire score between groups
12 weeks
Change in VascuQOL-6 (VQ6) quality of life survey
Time Frame: 12 weeks
Change in VascuQOL-6 (VQ6) quality of life survey between groups
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dallas VA Medical Center

Investigators

  • Principal Investigator: Subhash Banerjee, MD, MBA, Dallas VA Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2021

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (ACTUAL)

January 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1602740

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD are to be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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