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NCT05209724 Clinical Trial

Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— ROMEPAD  

Official title:
Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05209724
Other study ID # 1602740
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 21, 2021
Est. completion date June 2023

Study information
Verified date January 2022
Source Dallas VA Medical Center
Contact McCall Walker, MD
Phone 985-381-6661
Email mccall.walker@phhs.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 56
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Provider supervision/ feedback
Provider supervision/ feedback provided before and after walking sessions

Locations
Country Name City State
United States Dallas North Texas Veterans Affairs Hospital Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in 6 minute walk test distance between groups Change in 6 minute walk test distance between groups 12 weeks
Secondary Change in Walking Impairment Questionnaire score Change in Walking Impairment Questionnaire score between groups 12 weeks
Secondary Change in VascuQOL-6 (VQ6) quality of life survey Change in VascuQOL-6 (VQ6) quality of life survey between groups 12 weeks
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