Exercise Therapy for PAD

(PREPARE-IT Trial)

Overseen By Charles G Gronau, DCEP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palo Alto Veterans Institute for Research

Disqualifiers: Uncontrolled diabetes, Malignancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of exercise therapy for individuals with peripheral artery disease (PAD) who require a stent. It tests various exercise plans, implemented either before or after the stent procedure, to assess their impact on recovery and walking improvement. The trial seeks participants diagnosed with PAD who experience leg pain while walking and are planning to receive a stent. Participants will follow a personalized exercise routine that includes both in-clinic and at-home sessions. As an unphased trial, this study provides a unique opportunity to enhance understanding of how exercise can aid recovery and improve the quality of life for PAD patients.

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 trial coordinators or your doctor.

What prior data suggests that this exercise therapy is safe for patients with peripheral arterial disease?

Research shows that exercise programs before and after treatment are safe and beneficial for people with peripheral artery disease (PAD). These programs can ease walking and enhance overall quality of life. For instance, supervised exercise therapy carries a very low risk of complications, allowing most people to participate without issues.

Exercise therapy also helps individuals perform everyday tasks more easily. These programs not only aid in recovery but also enhance the overall health of people with PAD. The guidelines ensure safety and effectiveness, focusing on individual capabilities.

Overall, evidence supports the safety of these exercise therapies for people with PAD. They follow proven guidelines to improve health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to enhance exercise therapy for Peripheral Artery Disease (PAD) through prehabilitation and rehabilitation. Unlike standard care, which typically focuses on rehabilitation after surgery, this approach includes a prehabilitation phase that prepares patients with a personalized exercise regimen before any surgical intervention. This dual-phase strategy aims to improve walking performance and overall cardiovascular health, potentially leading to better surgical outcomes and faster recovery. By incorporating both aerobic and resistance training tailored to individual tolerance, the trial hopes to optimize patient health and mobility in a comprehensive manner.

What evidence suggests that this trial's exercise therapies could be effective for PAD?

This trial will compare different exercise therapy approaches for people with peripheral artery disease (PAD). Participants in the prehabilitation group will undergo 6 weeks of individualized exercise therapy before surgery. Those in the rehabilitation group will start their exercise sessions approximately 2 weeks after surgery. Another group will receive both prehabilitation and rehabilitation, combining both approaches. Studies have shown that exercising before and after surgery can greatly help people with PAD. Research indicates that these exercise programs make walking easier and reduce pain, aiding daily activities. Specifically, supervised exercise therapy enables people with PAD to walk longer distances without pain. This therapy not only manages symptoms but also improves overall quality of life. Patients who join these exercise programs often experience better surgical results and find it easier to function in everyday life. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with Peripheral Arterial Disease (PAD) who are scheduled to undergo artery stenting. Specific eligibility criteria details are not provided, so it's important to contact the study team for more information.

Inclusion Criteria

Able to perform exercise safely

I experience leg pain when I walk.

I have been diagnosed with peripheral artery disease.

Exclusion Criteria

Medically unstable patients

I have had a heart attack in the last 3 months.

Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo 6 weeks of individualized exercise therapy before the stent procedure, including a 1-week ramp-up period with in-clinic sessions followed by home-based exercise.

6 weeks

1 in-clinic session per week

Rehabilitation

Participants initiate exercise sessions approximately 2 weeks post-stent procedure, with a 1-week familiarization period followed by weekly in-clinic sessions for 6 weeks.

6 weeks

1 in-clinic session per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points.

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation and Rehabilitation

Trial Overview The trial examines whether exercise before and after surgery (prehabilitation and rehabilitation) can improve outcomes in PAD patients receiving artery stents. It involves an Exercise Intervention alongside VAPAHCS Rehabilitation Core Components.

How Is the Trial Designed?

Group I: Prehabilitation Experimental Treatment 2 Interventions

Subjects randomized to the prehabilitation group will undergo 6 weeks of individualized exercise therapy, including a 1-week ramp-up period (3 sessions) conducted at the VAPAHCS rehabilitation facility. Subjects will then exercise primarily at home, with an in-clinic exercise session repeated weekly for the duration of their participation. These sessions will be individualized based on tolerance and in accordance with standardized guidelines, but will generally consist of 45-60 min of supervised exercise that combines aerobic and resistance training, including warm-up and cool-down. Throughout the study, subjects will be asked to perform 30 minutes of daily unsupervised aerobic exercise of their choice, with an emphasis on improving walking performance at home. Guidelines for patient monitoring, safety, and prescription outlined by the American Heart Association, American College Sports Medicine, and American Association of Cardiovascular and Pulmonary Rehabilitation will be followed.

Group II: Prehabiliation and Rehabilitation Experimental Treatment 2 Interventions

Subjects randomized to the prehabilitation and rehabilitation group will undergo both the 6 weeks of prehabilitation pre-operative and 6 weeks of rehabilitation post-operative as described in their respective arm descriptions.

Group III: Rehabilitation Active Control 2 Interventions

Subjects randomized to the rehabilitation group will initiate exercise sessions approximately 2-weeks following endovascular intervention as outlined in guidelines for PAD. Patient stability and wound patency will be paramount considerations prior to a patient beginning the rehabilitation program. Similar to prehabilitation, subjects will undergo a 1-week, 3 session familiarization period conducted at the VAPAHCS rehabilitation facility, then return once weekly for in-clinic supervised sessions. The weekly in-person visits will be conducted at the rehabilitation center to monitor and encourage compliance, review activity questionnaires, download accelerometry data, and address any clinical concerns. Similar to participants in the prehabilitation group, the 6-week rehabilitation period will be individualized and follow standardized guidelines designed for rehabilitation in patients with PAD.

Prehabilitation and Rehabilitation is already approved in United States, European Union for the following indications:

Approved in United States as Supervised Exercise Therapy for:

• Peripheral Arterial Disease (PAD)
• Claudication Symptoms

Approved in European Union as Cardiac Rehabilitation for:

• Peripheral Arterial Disease (PAD)
• Cardiovascular Disease Prevention

Who Is Running the Clinical Trial?

Palo Alto Veterans Institute for Research

Lead Sponsor

Trials

58

Recruited

8,800+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study of 97 patients referred for prehabilitation before coronary artery bypass grafting (CABG), only 49% attended an initial intake visit, highlighting challenges in patient engagement with prehabilitation programs.

Patients who completed prehabilitation showed significantly higher rates of participation in postoperative cardiac rehabilitation and improvements in key health metrics, such as cardiorespiratory fitness and mental health, suggesting that prehabilitation can enhance recovery outcomes for CABG patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational study examining utilization of prehabilitation and its association with postoperative cardiac rehabilitation participation and risk factors following coronary artery bypass grafting. Rouleau, CR., Chirico, D., Hauer, T., et al.[2022]

A two-week exercise-based prehabilitation program significantly improved functional capacity and quality of life in patients awaiting coronary artery bypass graft surgery, with no complications reported during the intervention.

Patients in the intervention group showed greater improvements in their six-minute walk test and Timed-Up-and-Go Test scores both before and after surgery compared to the control group, indicating enhanced recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Steinmetz, C., Bjarnason-Wehrens, B., Baumgarten, H., et al.[2022]

Preoperative exercise, including various forms of training, significantly reduces the length of stay in the intensive care unit (ICU) after cardiac surgery, indicating improved recovery outcomes.

Patients who engaged in preoperative exercise showed better physical function post-surgery, although there were no significant differences in white blood cell count or mental health compared to those who did not exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative exercise and recovery after cardiac surgery: a meta-analysis. Zheng, YT., Zhang, JX.[2023]

Prehabilitation, which focuses on improving patients' functional capacity and managing risks before surgery, has been shown to reduce post-operative complications and improve overall outcomes in various surgical procedures, including lung cancer resection and coronary artery bypass grafting.

Incorporating prehabilitation alongside traditional rehabilitation not only enhances physical function but also lowers the risk of adverse events, helping patients return to normal activities more effectively after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation Coming of Age: IMPLICATIONS FOR CARDIAC AND PULMONARY REHABILITATION. Myers, J., Niebauer, J., Humphrey, R.[2023]

A 3-month prehabilitation program involving aerobic and strength training for elderly patients prior to abdominal or cardiac surgery can lead to fewer postoperative complications and a shorter hospital stay, based on a study of 275 patients.

The recommended prehabilitation includes aerobic training at 45-65% of maximal heart rate reserve and high-intensity interval training, along with strength training focused on major muscle groups, which together enhance cardiovascular function and reduce functional disability post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing functional exercise capacity in the elderly surgical population. Carli, F., Zavorsky, GS.[2022]

Prehabilitation before cardiac surgery has been shown to significantly reduce postoperative pulmonary complications (PPCs) and length of hospital stay, based on a review of 10 studies including 6 randomized controlled trials.

There were no adverse events or increased mortality associated with prehabilitation, making it a safe and beneficial intervention, particularly for older patients and those at higher risk for PPCs, with inspiratory muscle training showing the most positive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does prehabilitation improve outcomes in cardiac surgical patients? Sandhu, MS., Akowuah, EF.[2020]

Preoperative exercise training, or prehabilitation, is associated with improved clinical outcomes such as shorter hospital stays and fewer postoperative complications in patients undergoing cardiac and vascular surgeries, based on a review of nine studies.

Patients who participated in prehabilitation also reported better physical functioning and quality of life, indicating that exercise-based interventions can enhance overall well-being before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Exercise Rehabilitation in Cardiac and Vascular Interventions. Drudi, LM., Tat, J., Ades, M., et al.[2020]

Prehabilitation, which includes physical exercise, nutritional, and psychological support before surgery, has been shown to improve cardiopulmonary fitness and reduce postoperative complications, leading to better recovery outcomes.

Current evidence suggests that individualized prehabilitation programs, which can be home-based or supervised in hospitals, are essential for maximizing effectiveness, although more research is needed to determine the optimal structure of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. Chmelo, J., Chmelová, I., Phillips, AW.[2021]

The PrEPS trial is a randomized controlled study involving 180 participants undergoing elective cardiac surgery, aiming to assess the feasibility and impact of a prehabilitation program that includes exercise and inspiratory muscle training on preoperative functional exercise capacity.

The primary outcome will measure changes in functional exercise capacity using the 6-minute walk test, while secondary outcomes will evaluate various factors such as respiratory function, quality of life, and postoperative complications, potentially improving overall patient outcomes before and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol. Akowuah, E., Mathias, A., Bardgett, M., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40527394/

Protocol and study design of the PREPARE-IT trial Recent studies have consistently demonstrated better functional, psychosocial, and surgery-related morbidity outcomes among subjects participating in pre- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001788

Prehabilitation and rehabilitation in peripheral arterial ... Both prehabilitation and rehabilitation programs have been shown to improve functional capabilities, surgical outcomes, and quality of life in patients with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06566976

NCT06566976 | Prehabilitation and Rehabilitation in PAD To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.

4. acc.org acc.org/Latest-in-Cardiology/Articles/2025/04/02/13/44/Exercise-Therapy-in-Symptomatic-Peripheral-Artery-Disease

Exercise Therapy in Symptomatic Peripheral Artery Disease Randomized data suggest that SET can improve pain and maximal walking distance as initial treatment and in addition to revascularization in patients with PAD ...

5. heart.org heart.org/-/media/Files/Health-Topics/Peripheral-Artery-Disease/PAD-Webinars/Webinar-3-Exercise-in-PAD-slides.pdf?sc_lang=en

Supervised Exercise Therapy for Peripheral Artery Disease ... Collecting Outcome Data. • Not a CMS requirement, but part of “Best Practices” for Cardiac Rehabilitation. • Collect same measurements as at baseline.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3061490/

Exercise Rehabilitation in Peripheral Artery Disease Exercise training markedly improves walking ability in PAD patients with intermittent claudication. A meta-analysis performed in 1995 that included uncontrolled ...

7. cms.gov cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?NCAId=287

NCA - Supervised Exercise Therapy (SET) for Symptomatic ... There is ample evidence to demonstrate that supervised exercise therapy is an effective treatment for Peripheral Arterial Disease (PAD), a cardiovascular ...