Prehabilitation and Rehabilitation in PAD
- Conditions
- Peripheral Arterial Disease
- Interventions
- Other: Exercise InterventionOther: VAPAHCS Rehabilitation Core Components
- Registration Number
- NCT06566976
- Lead Sponsor
- Palo Alto Veterans Institute for Research
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- Medically unstable patients
- Recent MI within 3 months
- Malignancy
- Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
- Alcoholism or other recreational drug use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation Exercise Intervention 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. Prehabilitation VAPAHCS Rehabilitation Core Components 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. Prehabiliation and Rehabilitation Exercise Intervention 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. Rehabilitation Exercise Intervention 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. Rehabilitation VAPAHCS Rehabilitation Core Components 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. Prehabiliation and Rehabilitation VAPAHCS Rehabilitation Core Components 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.
- Primary Outcome Measures
Name Time Method Time to claudication pain Baseline, 6 weeks, 14 weeks, 22 weeks Time to initial onset of claudication pain with exercise treadmill test.
- Secondary Outcome Measures
Name Time Method Insulin sensitivity Baseline, 6 weeks, 14 weeks, 22 weeks Fasting glucose and insulin samples will be obtained from blood draw to generate Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score.
Walking Up to 22 weeks Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device.
Energy expenditure Up to 22 weeks Energy expenditure will be quantified using fitness/health tracking device.
Lower body strength Baseline, 6 weeks, 14 weeks, 22 weeks 1 repetition max for Leg Extension.
Lipid panel Baseline, 6 weeks, 14 weeks, 22 weeks Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw.
Sodium Baseline, 6 weeks, 14 weeks, 22 weeks Standard Chem 20 blood draw will be used to obtain sodium in blood value.
Homocysteine Baseline, 6 weeks, 14 weeks, 22 weeks Homocysteine will be assessed from blood draw.
D-dimer Baseline, 6 weeks, 14 weeks, 22 weeks D-dimer will be assessed from blood draw.
Calcium Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain calcium in blood value.
Potassium Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain potassium in blood value.
Chloride Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain chloride in blood value.
AST/GOTU/l Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain AST/GOTU/l in blood value.
ALT/GPT Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain ALT/GPT in blood value.
ALK Phosphatase Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain ALT/GPT in blood value.
Urea Nitrogen Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain urea nitrogen in blood value.
Creatinine Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain creatinine in blood value.
Blood protein Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain blood protein value.
Peak VO2 Baseline, 6 weeks, 14 weeks, 22 weeks Peak V02 will be determined on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses.
6-minute walk test (6MWT) Baseline, 6 weeks, 14 weeks, 22 weeks Total distance (meters) of walk in 6 minutes.
Walking Impairment Questionnaire (WIQ) Baseline, 6 weeks, 14 weeks, 22 weeks Developed to evaluate walking limitations in patients with PAD. Assesses the ability of individuals to walk defined distances and speeds and climb stairs.
Peripheral Artery Questionnaire (PAQ) Baseline, 6 weeks, 14 weeks, 22 weeks 20-item questionnaire developed and validated specifically for PAD and is designed to quantify patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life.
Chair raises Baseline, 6 weeks, 14 weeks, 22 weeks Number of repetitions completed within 60 seconds (46cm high seat).
Upper body strength Baseline, 6 weeks, 14 weeks, 22 weeks 1 repetition max for Chest Press.
Hand grip strength Baseline, 6 weeks, 14 weeks, 22 weeks Maximum isometric strength will be measured using a hand grip dynamometer.
High-sensitivity C-reactive protein (hs-CRP) Baseline, 6 weeks, 14 weeks, 22 weeks High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw.
Interleukin-6 (IL-6) Baseline, 6 weeks, 14 weeks, 22 weeks Interleukin-6 (IL-6) will be assessed from blood draw.
Albumin Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain albumin in blood value.
Carbon dioxide Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain carbon dioxide in blood value.
Bilirubin Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain total bilirubin in blood value.
eGFR Baseline, 6 weeks, 14 weeks, 22 weeks Blood draw will be used to obtain eGFR value.
Trial Locations
- Locations (1)
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States