Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05209724

Acronym

ROMEPAD

Enrollment

Registered

2022-01-27

Start date

2021-11-21

Completion date

2023-06-30

Last updated

2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

PAD, Home walking, Remote monitoring, Claudication

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.

Interventions

BEHAVIORALProvider supervision/ feedback

Provider supervision/ feedback provided before and after walking sessions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in 6 minute walk test distance between groups	12 weeks	Change in 6 minute walk test distance between groups

Secondary

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

Countries

United States

Contacts

Primary ContactMcCall Walker, MD

mccall.walker@phhs.org985-381-6661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026