Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Time to claudication pain
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to claudication pain
Time Frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Time to initial onset of claudication pain with exercise treadmill test.
Secondary Outcomes
- Insulin sensitivity(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Walking(Up to 22 weeks)
- Energy expenditure(Up to 22 weeks)
- Lower body strength(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Lipid panel(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Sodium(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Homocysteine(Baseline, 6 weeks, 14 weeks, 22 weeks)
- D-dimer(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Calcium(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Potassium(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Chloride(Baseline, 6 weeks, 14 weeks, 22 weeks)
- AST/GOTU/l(Baseline, 6 weeks, 14 weeks, 22 weeks)
- ALT/GPT(Baseline, 6 weeks, 14 weeks, 22 weeks)
- ALK Phosphatase(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Urea Nitrogen(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Creatinine(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Blood protein(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Peak VO2(Baseline, 6 weeks, 14 weeks, 22 weeks)
- 6-minute walk test (6MWT)(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Walking Impairment Questionnaire (WIQ)(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Peripheral Artery Questionnaire (PAQ)(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Chair raises(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Upper body strength(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Hand grip strength(Baseline, 6 weeks, 14 weeks, 22 weeks)
- High-sensitivity C-reactive protein (hs-CRP)(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Interleukin-6 (IL-6)(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Albumin(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Carbon dioxide(Baseline, 6 weeks, 14 weeks, 22 weeks)
- Bilirubin(Baseline, 6 weeks, 14 weeks, 22 weeks)
- eGFR(Baseline, 6 weeks, 14 weeks, 22 weeks)
Investigators
Jonathan Myers
Principal Investigator
Palo Alto Veterans Institute for Research