Prehabilitation and Rehabilitation in PAD (PREPARE-IT)

Palo Alto Veterans Institute for Research

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Other: Exercise Intervention; Other: VAPAHCS Rehabilitation Core Components

Study type: Interventional

Funder types: Other

Identifiers

NCT06566976

MYE0018APR

Details and patient eligibility

About

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

Full description

Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person's ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.

Programs of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.

Although the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female adult diagnosed with peripheral artery disease (PAD)
• Experiencing leg pain while walking
• Scheduled to have a stent for PAD
• Able to perform exercise safely
• Postmenopausal and not of child bearing capacity

Exclusion criteria

• Medically unstable patients
• Recent MI within 3 months
• Malignancy
• Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
• Alcoholism or other recreational drug use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Prehabilitation

Experimental group

Description:

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.

Treatment:

Other: VAPAHCS Rehabilitation Core Components

Other: Exercise Intervention

Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Other: VAPAHCS Rehabilitation Core Components

Other: Exercise Intervention

Prehabiliation and Rehabilitation

Experimental group

Description:

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.

Treatment:

Other: VAPAHCS Rehabilitation Core Components

Other: Exercise Intervention