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

Dallas VA Medical Center

Status: Unknown

Conditions: Peripheral Arterial Disease

Treatments: Behavioral: Provider supervision/ feedback

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05209724

1602740

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Provider Supervised

Experimental group

Description:

Digital monitoring system with provider supervision

Treatment:

Behavioral: Provider supervision/ feedback

Self Supervised

No Intervention group

Description:

Digital monitoring system without provider supervision