Prehabilitation and Rehabilitation in PAD

Palo Alto Veterans Institute for Research300 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Peripheral Arterial Disease

Interventions

Exercise InterventionOTHER

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.

VAPAHCS Rehabilitation Core ComponentsOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Palo Alto Health Care System

Palo Alto, California, United States

RECRUITING