NCT06566976

Prehabilitation and Rehabilitation in PAD

Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Palo Alto Veterans Institute for Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
OTHER	Exercise Intervention	Aerobic and resistance exercise will be components of the prehabiliation and rehabilitation programs. Given the presence of PAD, a particular emphasis will be placed on volume of walking and improving walking performance.
OTHER	VAPAHCS Rehabilitation Core Components	The prehabilitation and rehabilitation programs include all Core Components of rehabilitation as outlined in guidelines. The current clinical VAPAHCS program includes smoking cessation, nutrition, risk factor management and psychosocial counseling referrals as appropriate, and these services will be available for the current proposal.

Timeline

• Start date: 2024-03-07
• Primary completion: 2027-01-31
• Completion: 2027-07-25
• First posted: 2024-08-22
• Last updated: 2024-08-22

Locations

1 site across 1 country: United States