Remote Monitoring of Home Exercise in Peripheral Arterial Disease
ROMEPAD
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2021
CompletedFirst Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJanuary 27, 2022
January 1, 2022
1.5 years
January 13, 2022
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in 6 minute walk test distance between groups
Change in 6 minute walk test distance between groups
12 weeks
Secondary Outcomes (2)
Change in Walking Impairment Questionnaire score
12 weeks
Change in VascuQOL-6 (VQ6) quality of life survey
12 weeks
Study Arms (2)
Provider Supervised
EXPERIMENTALDigital monitoring system with provider supervision
Self Supervised
NO INTERVENTIONDigital monitoring system without provider supervision
Interventions
Provider supervision/ feedback provided before and after walking sessions
Eligibility Criteria
You may qualify if:
- Age \>18
- Diagnosis of PAD (based on ABI \<0.9 in either leg or prior intervention) with mild/moderate claudication
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dallas North Texas Veterans Affairs Hospital
Dallas, Texas, 75216, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Subhash Banerjee, MD, MBA
Dallas VA Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 13, 2022
First Posted
January 27, 2022
Study Start
November 21, 2021
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
January 27, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
No IPD are to be shared.