NCT05209724
Unknown
Not Applicable
Remote Monitoring of Home Exercise in Peripheral Arterial Disease
ConditionsPeripheral Arterial Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Dallas VA Medical Center
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change in 6 minute walk test distance between groups
- Last Updated
- 4 years ago
Overview
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.
Investigators
Subhash Banerjee
Principal Investigator
Dallas VA Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in 6 minute walk test distance between groups
Time Frame: 12 weeks
Change in 6 minute walk test distance between groups
Secondary Outcomes
- Change in VascuQOL-6 (VQ6) quality of life survey(12 weeks)
- Change in Walking Impairment Questionnaire score(12 weeks)
Study Sites (1)
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