Exercise Therapy for PAD

(PREPARE-IT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Palo Alto Veterans Institute for Research

Disqualifiers: Uncontrolled diabetes, Malignancy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Prehabilitation and Rehabilitation, Supervised Exercise Therapy, Cardiac Rehabilitation, Preoperative Exercise Therapy, Postoperative Exercise Therapy for PAD?

Research shows that prehabilitation, which includes exercise before surgery, can improve recovery and reduce complications after cardiac and vascular surgeries. This suggests that similar exercise programs might help patients with PAD (peripheral artery disease) by improving fitness and reducing surgery-related risks. ^{1 2 3 4 5}

Is exercise therapy safe for humans?

Exercise therapy, including prehabilitation and rehabilitation, is generally safe for humans and has been shown to reduce post-operative complications and improve outcomes in various surgeries, such as cardiac and vascular interventions. ^{2 4 6 7 8}

How does the treatment for PAD differ from other treatments?

The treatment for PAD (Peripheral Artery Disease) using prehabilitation and rehabilitation is unique because it focuses on improving fitness and functional capacity before and after surgery, which can lead to better recovery and reduced complications. This approach is different from traditional treatments that typically focus only on post-surgery rehabilitation. ^{2 4 5 6 9}

Research Team

Eligibility Criteria

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

I experience leg pain when I walk.

I have been diagnosed with peripheral artery disease.

Able to perform exercise safely

Exclusion Criteria

Medically unstable patients

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

Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)

Trial Timeline

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

Treatment Details

Interventions

• Prehabilitation and Rehabilitation (Behavioural Intervention)

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.

Participant Groups

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.

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+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE

Findings from Research

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]

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]

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, 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]

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]

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]

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]

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]

References

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

Does prehabilitation improve outcomes in cardiac surgical patients? [2020]

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

Preoperative Exercise Rehabilitation in Cardiac and Vascular Interventions. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Preoperative exercise and recovery after cardiac surgery: a meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Optimizing functional exercise capacity in the elderly surgical population. [2022]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Prehabilitation, improving postoperative outcomes. [2021]

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

Prehabilitation Coming of Age: IMPLICATIONS FOR CARDIAC AND PULMONARY REHABILITATION. [2023]

7. Netherlands 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol. [2023]

9. England 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. [2022]