Prehabilitation and Rehabilitation in PAD (PREPARE-IT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Exercise Intervention; Other: VAPAHCS Rehabilitation Core Components

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan N Myers, PhD; Phone Number: 64661 650-493-5000; Email: drj993@aol.com
• Study Contact Backup: Name: Charles G Gronau, DCEP; Phone Number: 618-746-69565; Email: gronauc92@gmail.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • VA Palo Alto Health Care System
      • Contact: Jonathan N Myers, PhD; Phone Number: 64661 650-493-5000; Email: drj993@aol.com
      • Contact: Charles G Gronau, DCEP; Phone Number: 618-746-6956; Email: gronauc92@gmail.com
      • Principal Investigator: Jonathan N Myers, PhD
      • Sub-Investigator: Charles G Gronau, DCEP
      • Sub-Investigator: Khin N Chan, MD
      • Sub-Investigator: Pallavi Gautam, MPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation; 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.	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 Names: Exercise Therapy; 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.
Active Comparator: Rehabilitation; 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.	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 Names: Exercise Therapy; 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.
Experimental: Prehabiliation and Rehabilitation; 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.	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 Names: Exercise Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to claudication pain	Time to initial onset of claudication pain with exercise treadmill test.	Baseline, 6 weeks, 14 weeks, 22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2	Peak V02 will be determined on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses.	Baseline, 6 weeks, 14 weeks, 22 weeks
6-minute walk test (6MWT)	Total distance (meters) of walk in 6 minutes.	Baseline, 6 weeks, 14 weeks, 22 weeks
Walking Impairment Questionnaire (WIQ)	Developed to evaluate walking limitations in patients with PAD. Assesses the ability of individuals to walk defined distances and speeds and climb stairs.	Baseline, 6 weeks, 14 weeks, 22 weeks
Peripheral Artery Questionnaire (PAQ)	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.	Baseline, 6 weeks, 14 weeks, 22 weeks
Walking	Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device.	Up to 22 weeks
Energy expenditure	Energy expenditure will be quantified using fitness/health tracking device.	Up to 22 weeks
Chair raises	Number of repetitions completed within 60 seconds (46cm high seat).	Baseline, 6 weeks, 14 weeks, 22 weeks
Upper body strength	1 repetition max for Chest Press.	Baseline, 6 weeks, 14 weeks, 22 weeks
Lower body strength	1 repetition max for Leg Extension.	Baseline, 6 weeks, 14 weeks, 22 weeks
Hand grip strength	Maximum isometric strength will be measured using a hand grip dynamometer.	Baseline, 6 weeks, 14 weeks, 22 weeks
Insulin sensitivity	Fasting glucose and insulin samples will be obtained from blood draw to generate Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score.	Baseline, 6 weeks, 14 weeks, 22 weeks
Lipid panel	Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw.	Baseline, 6 weeks, 14 weeks, 22 weeks
Sodium	Standard Chem 20 blood draw will be used to obtain sodium in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Homocysteine	Homocysteine will be assessed from blood draw.	Baseline, 6 weeks, 14 weeks, 22 weeks
High-sensitivity C-reactive protein (hs-CRP)	High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw.	Baseline, 6 weeks, 14 weeks, 22 weeks
Interleukin-6 (IL-6)	Interleukin-6 (IL-6) will be assessed from blood draw.	Baseline, 6 weeks, 14 weeks, 22 weeks
D-dimer	D-dimer will be assessed from blood draw.	Baseline, 6 weeks, 14 weeks, 22 weeks
Blood protein	Blood draw will be used to obtain blood protein value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Albumin	Blood draw will be used to obtain albumin in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Calcium	Blood draw will be used to obtain calcium in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Potassium	Blood draw will be used to obtain potassium in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Chloride	Blood draw will be used to obtain chloride in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Carbon dioxide	Blood draw will be used to obtain carbon dioxide in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
AST/GOTU/l	Blood draw will be used to obtain AST/GOTU/l in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
ALT/GPT	Blood draw will be used to obtain ALT/GPT in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
ALK Phosphatase	Blood draw will be used to obtain ALT/GPT in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Bilirubin	Blood draw will be used to obtain total bilirubin in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Urea Nitrogen	Blood draw will be used to obtain urea nitrogen in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
Creatinine	Blood draw will be used to obtain creatinine in blood value.	Baseline, 6 weeks, 14 weeks, 22 weeks
eGFR	Blood draw will be used to obtain eGFR value.	Baseline, 6 weeks, 14 weeks, 22 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	The Endo Pat 2000 system will be used to perform this procedure. Both forearms will be occluded with a standard blood pressure cuff for 5 minutes.	Baseline, 6 weeks, 14 weeks, 22 weeks
Ankle-brachial index (ABI)	Using a standard brachial artery cuff method with a Doppler ultrasound probe at the posterior tibial artery to determine ABI.	Baseline, 6 weeks, 14 weeks, 22 weeks
Exercise Benefits and Barriers Scale (EBBS)	Perceived barriers and benefits to physical activity will be assessed using two methods: a semi-structured interview and administration of the Exercise Benefits and Barriers Scale (EBBS), to obtain both open-ended qualitative and quantitative data on these constructs. The EBBS may be used in its entirety or as two seperate scales. As a whole, scoring for EBBS ranges from 43 to 172 with a higher score being the individual perceives exercise more positively. When the Benefits Scale is used alone, the score range is between 29 to 116 with the higher the score being the individual perceives exercise more positively. When the Barriers Scale is used alone, the score range is between 14 to 56. The higher the score on the Barriers Scale, the greater the perception of barriers to exercise.	Baseline, 6 weeks, 14 weeks, 22 weeks

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: Patient-Centered Outcomes Research Institute

Publications and helpful links

General Publications

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• ACSM Guidelines for Exercise Testing and Exercise Prescription, 9th edition. Baltimore: LW&W, 2021.
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• Liang G, Huang X, Hirsch J, Mehmi S, Fonda H, Chan K, Huang NF, Aalami O, Froelicher VF, Lee DP, Myers J, Lee AS, Nguyen PK. Modest Gains After an 8-Week Exercise Program Correlate With Reductions in Non-traditional Markers of Cardiovascular Risk. Front Cardiovasc Med. 2021 Jun 17;8:669110. doi: 10.3389/fcvm.2021.669110. eCollection 2021.
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• McElrath M, Myers J, Chan K, Fonda H. Exercise adherence in the elderly: Experience with abdominal aortic aneurysm simple treatment and prevention. J Vasc Nurs. 2017 Mar;35(1):12-20. doi: 10.1016/j.jvn.2016.08.002.
• Hallgren KA, Witkiewitz K. Missing data in alcohol clinical trials: a comparison of methods. Alcohol Clin Exp Res. 2013 Dec;37(12):2152-60. doi: 10.1111/acer.12205. Epub 2013 Jul 24.
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• American Association of Cardiovascular and Pulmonary Rehabilitation; American College of Cardiology Foundation; American Heart Association Task Force on Performance Measures (Writing Committee to Develop Clinical Performance Measures for Cardiac Rehabilitation); Thomas RJ, King M, Lui K, Oldridge N, Pina IL, Spertus J. AACVPR/ACCF/AHA 2010 Update: Performance Measures on Cardiac Rehabilitation for Referral to Cardiac Rehabilitation/Secondary Prevention Services Endorsed by the American College of Chest Physicians, the American College of Sports Medicine, the American Physical Therapy Association, the Canadian Association of Cardiac Rehabilitation, the Clinical Exercise Physiology Association, the European Association for Cardiovascular Prevention and Rehabilitation, the Inter-American Heart Foundation, the National Association of Clinical Nurse Specialists, the Preventive Cardiovascular Nurses Association, and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2010 Sep 28;56(14):1159-67. doi: 10.1016/j.jacc.2010.06.006. No abstract available.
• Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Vogt P, Ratti R, Muller P, Miettunen R, Buser P. Effect of exercise training on myocardial remodeling in patients with reduced left ventricular function after myocardial infarction: application of magnetic resonance imaging. Circulation. 1997 Apr 15;95(8):2060-7. doi: 10.1161/01.cir.95.8.2060.
• Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Muller P, Buser P, Stulz P, Vogt P, Ratti R. Effect of high intensity exercise training on central hemodynamic responses to exercise in men with reduced left ventricular function. J Am Coll Cardiol. 1997 Jun;29(7):1591-8. doi: 10.1016/s0735-1097(97)82540-5.
• Myers J, Fonda H, Vasanawala M, Chung K, Segall G, Chan K, Nguyen P. PCI Alternative Using Sustained Exercise (PAUSE): Rationale and trial design. Contemp Clin Trials. 2019 Apr;79:37-43. doi: 10.1016/j.cct.2019.02.010. Epub 2019 Feb 20.
• Campbell EB, Delgadillo M, Lazzeroni LC, Louras PN, Myers J, Yesavage J, Fairchild JK. Cognitive Improvement Following Physical Exercise and Cognitive Training Intervention for Older Adults With MCI. J Gerontol A Biol Sci Med Sci. 2023 Mar 1;78(3):554-560. doi: 10.1093/gerona/glac189.
• Moore CS, Myers J, Yesavage JA, Fairchild JK. Ventilatory efficiency is associated with memory decay in older adults with amnestic mild cognitive impairment. Submitted, 2022
• Moore CS, Myers J, Yesavage JA, Fairchild JK. Assessment of physical activity in older adults with cognitive impairment. Submitted, 2022
• Fairchild JK, Myers J, Louras P, Jo B, McNerney MW, Salehi A, Hallmayer J, Yesavage J. A Combined physical and cognitive training program for veterans with mild cognitive impairment: A randomized clinical trial. Submitted, 2022.

Helpful Links

• U.S. Markets for Peripheral Vascular Stents
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• Wilson C, Colombo R. Association of Community Cancer Centers. Making the business case for implementing prehabilitation services
• Bloom E. Prehabilitation evidence and insight review. Macmillan National Cancer Rehabilitation, 2018.
• Carrol AE, Frakt, A. It Saves Lives. It can save money. So why aren't we spending more on public health? NY Times 5/28/18
• Centers for Medicare & Medicaid Services. Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease
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Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 25, 2027

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: MYE0018APR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No