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Behavioural Intervention

Telehealth-Based Walking Program for Peripheral Arterial Disease (TREK-PAD Trial)

N/A

Waitlist Available

Led By Elizabeth A Jackson, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of lower extremity PAD due to atherosclerosis

Claudication with walking defined as stage 1-3 on the Rutherford Scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 36 weeks

Awards & highlights

TREK-PAD Trial Summary

This trial will test two methods of delivering a home-based walking program to adults with peripheral arterial disease to improve their ability to walk for longer periods and quality of life.

Who is the study for?

This trial is for men and women with lower extremity peripheral arterial disease (PAD) who experience claudication, can walk at least one block, have internet access, and do less than 150 minutes of physical activity per week. Excluded are those in nursing homes, with unstable heart conditions or recent cardiovascular events, planned surgeries, substance abuse issues, severe psychiatric disorders or comorbidities that severely limit walking.Check my eligibility

What is being tested?

The study tests two home-based walking program delivery methods for PAD patients: web-based and telehealth. Participants will be randomly assigned to one method or usual care for 12 weeks; some may then try a combination of both methods for another 12 weeks. The total study duration is 36 weeks including follow-ups with treadmill walks and quality of life questionnaires.See study design

What are the potential side effects?

Since the intervention involves a walking program delivered either via the internet or telehealth without medications involved, side effects are minimal but could include typical exercise-related issues such as muscle soreness or fatigue.

TREK-PAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PAD in my legs due to clogged arteries.

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I experience leg pain when walking but can walk without assistance.

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I can walk at least one city block without help.

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I understand and can agree to the study's procedures and risks.

TREK-PAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in PAD-specific health-related quality of life

Change in claudication free walking distance

Change in general health-quality of life

+1 more

TREK-PAD Trial Design

2Treatment groups

Experimental Treatment

Group I: Telehealth Counseling Walking ProgramExperimental Treatment1 Intervention

Telehealth sessions allow participants review step-count goals, progress over time and access to walking tips with the study coordinator

Group II: Internet-based Walking ProgramExperimental Treatment1 Intervention

Internet pages allow participants to see step-count goals, progress over time and access to walking tips

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,378 Total Patients Enrolled

12 Trials studying Peripheral Arterial Disease

787 Patients Enrolled for Peripheral Arterial Disease

Elizabeth A Jackson, MDPrincipal InvestigatorBirmingham VA Medical Center, Birmingham, AL

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process for this clinical trial still ongoing?

"As documented on clinicaltrials.gov, this trial is not currently recruiting subjects. Though initially posted in January of 2024 and last modified in September of 2023, no further entries are being accepted at the present time. However, there are 207 different medical studies that remain open for enrollment right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease

2024. "Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033924.

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