Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Behavioral: Provider supervision/ feedback

• Registration Number: NCT05209724
• Lead Sponsor: Dallas VA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-21
• Status Verified: 2022-01
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Provider Supervised	Provider supervision/ feedback	Digital monitoring system with provider supervision

Primary Outcome Measures

Name	Time	Method
Change in 6 minute walk test distance between groups	12 weeks	Change in 6 minute walk test distance between groups

Secondary Outcome Measures

Name	Time	Method
Change in VascuQOL-6 (VQ6) quality of life survey	12 weeks	Change in VascuQOL-6 (VQ6) quality of life survey between groups
Change in Walking Impairment Questionnaire score	12 weeks	Change in Walking Impairment Questionnaire score between groups

Trial Locations

Locations (1)

Dallas North Texas Veterans Affairs Hospital; 🇺🇸 Dallas, Texas, United States