Remote Monitoring of Home Exercise in Peripheral Arterial Disease

NCT ID: NCT05209724

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-21

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Provider Supervised

Digital monitoring system with provider supervision

Group Type EXPERIMENTAL

Provider supervision/ feedback

Intervention Type BEHAVIORAL

Provider supervision/ feedback provided before and after walking sessions

Self Supervised

Digital monitoring system without provider supervision

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Provider supervision/ feedback

Provider supervision/ feedback provided before and after walking sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dallas VA Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Subhash Banerjee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Subhash Banerjee, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Dallas VA Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dallas North Texas Veterans Affairs Hospital

Dallas, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

McCall Walker, MD

Role: CONTACT

985-381-6661

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cristina Sanchez

Role: primary

214-857-3048

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1602740

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-Managed Walking Improves Function
NCT00611988 COMPLETED PHASE2