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

Trial Summary

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 data supports the effectiveness of the treatment Telehealth-Based Walking Program for Peripheral Arterial Disease?

Research shows that structured home-based exercise programs can improve walking ability and quality of life in patients with peripheral arterial disease. These programs, which can be delivered via telehealth, have been found to be a cost-effective alternative to more invasive treatments. ^{1 2 3 4 5}

Is the Telehealth-Based Walking Program safe for humans?

Home-based exercise programs, including those delivered via telehealth, appear to be safe for people with peripheral arterial disease, with a very low rate of adverse events reported in studies. ^{1 3 5 6 7}

How is the Telehealth-Based Walking Program for Peripheral Arterial Disease different from other treatments?

The Telehealth-Based Walking Program is unique because it allows patients to exercise at home using technology like tele-coaching and tele-monitoring, making it more convenient and accessible compared to traditional supervised walking programs that require travel to medical facilities. ^{3 5 6 8 9}

What is the purpose of this trial?

Walking is beneficial for adults with peripheral arterial disease. Benefits include the ability to walk for longer periods and general well being (quality of life). This study will look at two types of delivery methods for a home-based walking program. The walking program includes step count goals, information on healthy walking and motivational messages. The two delivery methods include a web-based delivery and an telehealth delivery. Participants are randomized to either one of the delivery methods or usual care. After 12 weeks participants in the web based or telehealth based groups maybe re-randomized to receive a combination of both web-based and telehealth for a second 12 week period. After 24 weeks, everyone is followed for an additional 12 weeks, so the total time a participant is in the study is 36 weeks. At baseline, 12, 24 and 36 weeks the investigators ask participant to walk (slowly) on a treadmill, perform a six-minute walk test, and several questionnaires on quality of life. Vouchers are provided at each study visit. All participants who complete the study also keep their pedometer.

Research Team

Elizabeth A Jackson, MD

Principal Investigator

Birmingham VA Medical Center, Birmingham, AL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. [2018]

2. United States 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of structured home-based exercise on walking ability in patients with peripheral arterial disease: a meta-analysis. [2015]

4. United States 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. [2018]

5. Switzerland 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. [2021]

6. Switzerland 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Safety of home-based exercise for people with intermittent claudication: A systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Community walking programs for treatment of peripheral artery disease. [2021]

9. England 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. [2021]