Recruiting

Observational Study

Sponsor:

Dallas VA Medical Center

Code:

NCT05209724

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Provider supervision/ feedback

Study Details

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.

Conditions

Peripheral Arterial Disease

Study ID

NCT05209724

Start date

Nov 21, 2021

Status verified date

Jan, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Provider Supervised

Digital monitoring system with provider supervision

no intervention: Self Supervised

Digital monitoring system without provider supervision

Interventions

Provider supervision/ feedback

Provider supervision/ feedback provided before and after walking sessions

Primary outcome measure

  • Change in 6 minute walk test distance between groups [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

McCall Walker, MD

985-381-6661mccall.walker@phhs.org

Locations

Dallas North Texas Veterans Affairs Hospital

Recruiting

Dallas, Texas, United States, 75216

Contacts

Cristina Sanchez

214-857-3048cristina.sanchez@va.gov

More Information

Sponsor

Dallas VA Medical Center

Last update posted

Jan 27, 2022

Last verified

Jan, 2022

Keywords

  • PAD
  • Home walking
  • Remote monitoring
  • Claudication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dallas VA Medical Center on 2022-01-27.