ROMEPAD: Remote Monitoring of Home Exercise in Peripheral Arterial Disease

• Sponsor: Dallas VA Medical Center (U.S. Fed)
• Overall Status: Recruiting
• CT.gov ID: NCT05209724
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.3
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Behavioral: Provider supervision/ feedback	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote Monitoring of Home Exercise in Peripheral Arterial Disease
• Actual Study Start Date: Nov 21, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in 6 minute walk test distance between groups [12 weeks]

   Change in 6 minute walk test distance between groups

Secondary Outcome Measures

1. Change in Walking Impairment Questionnaire score [12 weeks]

   Change in Walking Impairment Questionnaire score between groups

2. Change in VascuQOL-6 (VQ6) quality of life survey [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dallas North Texas Veterans Affairs Hospital	Dallas	Texas	United States	75216

Sponsors and Collaborators

• Dallas VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Subhash Banerjee, Principal Investigator, Dallas VA Medical Center
• ClinicalTrials.gov Identifier: NCT05209724
• Other Study ID Numbers: 1602740
• First Posted: Jan 27, 2022
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Subhash Banerjee, Principal Investigator, Dallas VA Medical Center: PAD; Home walking; Remote monitoring; Claudication
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Results

No Results Posted as of Jan 27, 2022