Telehealth-Based Walking Program for Peripheral Arterial Disease

(TREK-PAD Trial)

Recruiting at 2 trial locations

Overseen By Megan A Baker, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe comorbidities, Recent CVD events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to deliver a walking program for individuals with peripheral arterial disease (PAD), a condition that reduces blood flow to the legs and can cause pain while walking. Participants will engage in a home-based walking program using either a web-based or telehealth approach, which includes setting step goals, receiving walking tips, and motivational messages. Individuals with PAD who experience leg pain while walking and have a sedentary lifestyle (less than 150 minutes of activity per week) may be suitable candidates. The trial seeks to identify which method improves walking endurance and overall quality of life. Participants will be monitored for a total of 36 weeks and can earn vouchers and a pedometer upon completion. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance daily living for those with PAD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these delivery methods for the walking program are safe?

Research has shown that home-based walking programs are generally safe for people with peripheral arterial disease (PAD). These programs can significantly improve the distance and frequency of walking for individuals with PAD. For the internet-based walking program, studies have found that online tools assist participants in maintaining their walking goals, which is crucial for managing PAD.

The telehealth counseling walking program is also considered safe. It uses phone or video calls to support participants, and studies have shown it helps people with PAD walk farther and faster.

Both programs aim to increase physical activity, which has been shown to be beneficial and well-tolerated in other studies. No serious safety issues have been reported, indicating that both methods are generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using telehealth-based walking programs for Peripheral Arterial Disease (PAD) because these programs offer a new way to improve patient engagement and convenience. Unlike traditional supervised exercise therapy, which often requires travel to clinics, the internet-based and telehealth counseling walking programs allow patients to participate from home. Participants can monitor their progress and receive personalized guidance and motivation, making it easier to adhere to the regimen. This approach not only promises to increase accessibility but also aims to enhance patient outcomes by providing ongoing support and feedback.

What evidence suggests that this trial's walking programs could be effective for peripheral arterial disease?

This trial will compare two different walking programs for people with peripheral arterial disease (PAD). Research has shown that online and telehealth walking programs can benefit people with PAD. Participants in the Internet-based Walking Program arm will use online resources to track step-count goals and progress, which has helped people walk farther without pain and improve overall walking distance. Meanwhile, those in the Telehealth Counseling Walking Program arm will have telehealth sessions with a study coordinator to review their goals and progress. Both programs aim to improve walking ability and quality of life for people with PAD and have proven practical and helpful, even for those in areas with limited healthcare access. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth A Jackson, MD

Principal Investigator

Birmingham VA Medical Center, Birmingham, AL

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I can walk at least one city block without help.

Exclusion Criteria

I am scheduled for a procedure to improve blood flow or an amputation soon.

I have not had a stroke, heart attack, or heart surgery in the last 3 months.

You are expected to live for less than six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Initial assessments and randomization to one of the study arms

1 week

1 visit (in-person)

Treatment Phase 1

Participants receive either web-based or telehealth delivered walking program or usual care

12 weeks

Weekly virtual check-ins

Treatment Phase 2

Non-responders are re-randomized to a combination of web-based and telehealth programs

12 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for longer-term responses and outcomes

12 weeks

1 visit (in-person) at 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Walking Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Telehealth Counseling Walking Program Experimental Treatment 1 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 Program Experimental Treatment 1 Intervention

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

Walking Program is already approved in United States for the following indications:

Approved in United States as Home-based Walking Exercise for:

• Peripheral Artery Disease
• Improvement of Walking Ability
• Enhancement of Quality of Life

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Structured home-based exercise (SHE) programs significantly improve maximal walking time (MWT) in patients with peripheral arterial disease (PAD), with an average increase of 66.78 seconds based on a meta-analysis of 5 randomized controlled trials involving 547 patients.

SHE programs also enhance pain-free walking time (PFWT) and self-reported walking ability, as indicated by improvements in the Walking Impairment Questionnaire (WIQ) scores, demonstrating their effectiveness in increasing overall walking ability in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of structured home-based exercise on walking ability in patients with peripheral arterial disease: a meta-analysis. Li, Y., Li, Z., Chang, G., et al.[2015]

Only 30.4% of vascular surgeons reported access to supervised exercise programs (SEPs) for managing peripheral arterial disease (PAD), highlighting a significant accessibility issue.

Structured home-based exercise programs (HEPs) were found to be effective alternatives, significantly improving functional capacity and quality of life compared to standard advice, although SEPs were superior in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. Makris, GC., Lattimer, CR., Lavida, A., et al.[2018]

Home-based exercise programs (HBEPs) for individuals with intermittent claudication (IC) are safe, with only four adverse events reported over 147,810 patient-hours, resulting in a complication rate of one event per 36,953 patient-hours.

Most adverse events were cardiac-related and occurred during high levels of claudication pain, suggesting that while HBEPs are generally safe, monitoring and possibly cardiac screening may be beneficial for those engaging in more intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of home-based exercise for people with intermittent claudication: A systematic review. Waddell, A., Seed, S., Broom, DR., et al.[2022]

A study of 99 patients with peripheral arterial disease (PAD) revealed that 87% expressed a need for an exercise program, and 67% showed interest in tele-coaching to support their physical activity, indicating a strong demand for technology-enabled exercise solutions.

The main barrier to physical activity for these patients was intermittent claudication, with 93% reporting pain and 92% needing rest, highlighting the importance of tailored interventions that address these challenges while leveraging technology for home-based exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring physical activity behaviour - needs for and interest in a technology-delivered, home-based exercise programme among patients with intermittent claudication. Cornelis, N., Buys, R., Fourneau, I., et al.[2018]

A randomized trial involving 60 patients with peripheral artery disease (PAD) will compare a structured home-based exercise program to a control group, focusing on improving pain-free walking distance and overall quality of life over 6 months.

The home-based exercise program is designed to be pain-free and may offer a sustainable and cost-effective alternative for improving mobility in PAD patients, potentially benefiting both patients and healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial. Manfredini, F., Lamberti, N., Traina, L., et al.[2021]

This study is designed to evaluate the effectiveness of an internet-based walking program versus telephone counseling, or a combination of both, in promoting regular walking among sedentary adults with peripheral arterial disease (PAD).

The trial will involve a 4-month intervention followed by an 8-month follow-up, assessing outcomes like walking distance and health-related quality of life, which could provide valuable insights into improving adherence to walking guidelines for PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease. Kumar, AM., Lyden, AK., Carlozzi, NE., et al.[2021]

Community walking programs for patients with peripheral artery disease (PAD) are less effective than supervised exercise programs, as shown in a review of 10 randomized controlled trials involving 558 patients, where peak walking performance was the primary outcome.

However, community walking programs that include more structured advice and feedback can achieve similar walking performance outcomes to supervised programs, suggesting they may be a practical alternative for patients who face barriers to facility-based exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community walking programs for treatment of peripheral artery disease. Mays, RJ., Rogers, RK., Hiatt, WR., et al.[2021]

A 6-month randomized controlled trial involving 194 patients with peripheral artery disease (PAD) showed that a home-based walking exercise program significantly improved self-efficacy, satisfaction with physical functioning, pain acceptance, and social functioning compared to a control group.

These improvements occurred independently of changes in walking performance, suggesting that the cognitive behavioral approach of the intervention effectively enhanced patients' psychological and social well-being related to their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A group-mediated, home-based physical activity intervention for patients with peripheral artery disease: effects on social and psychological function. Rejeski, WJ., Spring, B., Domanchuk, K., et al.[2021]

A 4-month study involving 27 elderly patients with peripheral arterial disease found that both a structured home-based exercise program and revascularization significantly improved quality of life and walking distances, with no significant difference between the two treatments.

The revascularization group showed greater improvements in 6-minute walk distance and ankle-brachial index, while the home-based exercise program was more cost-effective, suggesting both treatments are beneficial but may have different advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured Home-Based Exercise Versus Invasive Treatment: A Mission Impossible? A Pilot Randomized Study in Elderly Patients With Intermittent Claudication. Lamberti, N., Malagoni, AM., Ficarra, V., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02022423

Physical Activity Daily - An Internet-Based Walking ... Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment. Our Internet-based intervention, builds on a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11749748/

Effectiveness of home-based walking exercise for patients ... Home-based exercise interventions for patients with PAD and IC were beneficial in improving pain-free walking distance and maximal walking distance.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809783

Home-Based Walking Exercise and Supervised Treadmill ... Home-based walking exercise was associated with greater improvement in 6MW distance but not treadmill walking distance, in people with PAD.

4. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1272897/full

the WalkingPad randomized clinical trial The intervention improved distances and walking skills as well as the physical, mental, and disease-related quality of life among adults with PAD and IC.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714417304986

The Physical Activity Daily (PAD) Trial This paper presents the design specifications for a randomized clinical trial to examine the effectiveness of an internet-based walking program compared to a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06033924

Telehealth Delivered Home-based Walking for Vets With ... The objective of this study is to evaluate two delivery methods of home-based walking among Veterans with PAD. The investigators will use an innovative ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0890509624001316

Home-based Circuit Training and Community Walking for ... The aim of this study was to assess the feasibility of conducting a full scale trial of a 12-week HBEP for people living with symptomatic PAD.

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1707722

Home-Based Walking Exercise Intervention in Peripheral ... A home-based walking exercise program significantly improved walking endurance, physical activity, and patient-perceived walking endurance and speed in PAD ...