Prehabilitation and Rehabilitation in PAD

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease

• 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.

Study Timeline

• Study Start: 2024-03-07
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2027-01-31
• Study Completion: 2027-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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