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Behavioural Intervention
Telehealth-Based Walking Program for Peripheral Arterial Disease (TREK-PAD Trial)
N/A
Recruiting
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
Must not have
Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)
Recent CVD events (< 3 months) including stroke/TIA, MI, UA, PCI/CABG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 36 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PAD in my legs due to clogged arteries.
Select...
I experience leg pain when walking but can walk without assistance.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to walk and use a wheelchair.
Select...
I have not had a stroke, heart attack, or heart surgery in the last 3 months.
Select...
I do not have severe heart conditions or untreated complex heart issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 36 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in PAD-specific health-related quality of life
Change in claudication free walking distance
Change in general health-quality of life
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,641 Total Patients Enrolled
13 Trials studying Peripheral Arterial Disease
1,204 Patients Enrolled for Peripheral Arterial Disease
Elizabeth A Jackson, MDPrincipal InvestigatorBirmingham VA Medical Center, Birmingham, AL