Remote Monitoring of Home Exercise in Peripheral Arterial... | NCT05209724

Studies
Remote Monitoring of Home Exercise in Peripheral Arterial Disease

NCT05209724

Sponsor

Dallas VA Medical Center

Status

Unknown status

Last Update Posted

Jan 27, 2022Actual

Enrollment

56Estimated

Phase

Not Applicable

Conditions

Peripheral Arterial Disease

Interventions

Provider supervision/ feedback

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2021Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Jan 13, 2022

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2022

Last Update Posted Date

Jan 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Provider Supervised	Experimental	Digital monitoring system with provider supervision	Behavioral: Provider supervision/ feedback
Self Supervised	No Intervention	Digital monitoring system without provider supervision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Provider supervision/ feedback	Behavioral	Provider supervision/ feedback provided before and after walking sessions	Provider Supervised

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
McCall Walker, MD	Contact	985-381-6661		mccall.walker@phhs.org

Overall Officials

Name	Affiliation	Role
Subhash Banerjee, MD, MBA	Dallas VA Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dallas North Texas Veterans Affairs Hospital	Recruiting	Dallas	Texas	75216	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No IPD are to be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease
D007383	Intermittent Claudication

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided