Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-03-07
Study Completion Date
2027-07-25
Brief Summary
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To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
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Detailed Description
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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.
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.
Conditions
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Peripheral Arterial Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Exercise Intervention
Intervention Type
OTHER
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 Components
Intervention Type
OTHER
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.
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.
Group Type
ACTIVE_COMPARATOR
Exercise Intervention
Intervention Type
OTHER
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 Components
Intervention Type
OTHER
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.
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.
Group Type
EXPERIMENTAL
Exercise Intervention
Intervention Type
OTHER
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 Components
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
OTHER
Other Intervention Names
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Exercise Therapy
Eligibility Criteria
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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
* 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
* Recent MI within 3 months
* Malignancy
* Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
* Alcoholism or other recreational drug use
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Sponsor Role
collaborator
Palo Alto Veterans Institute for Research
OTHER
Sponsor Role
lead
Responsible Party
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Jonathan Myers
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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VA Palo Alto Health Care System
Palo Alto, California, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Chang P, Nead KT, Olin JW, Myers J, Cooke JP, Leeper NJ. Effect of physical activity assessment on prognostication for peripheral artery disease and mortality. Mayo Clin Proc. 2015 Mar;90(3):339-45. doi: 10.1016/j.mayocp.2014.12.016. Epub 2015 Jan 31.
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Brown R. Review of Article: Leeper, N.J., Myers, J., Zhou, M., Nead, K.T., Syed, A., Kojima, Y. ... Cooke, J.P. (2013). Exercise capacity is the strongest predictor of mortality in patients with peripheral arterial disease. Journal of Vascular Surgery, 57, 728-33. J Vasc Nurs. 2017 Jun;35(2):112-113. doi: 10.1016/j.jvn.2017.04.002. Epub 2017 Apr 28. No abstract available.
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Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
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Myers J, Chan K, Chen Y, Lit Y, Patti A, Massaband P, Kiratli BJ, Tamura M, Chertow GM, Rabkin R. Effect of a Home-Based Exercise Program on Indices of Physical Function and Quality of Life in Elderly Maintenance Hemodialysis Patients. Kidney Blood Press Res. 2021;46(2):196-206. doi: 10.1159/000514269. Epub 2021 Mar 26.
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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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Arena R, Myers J, Williams MA, Gulati M, Kligfield P, Balady GJ, Collins E, Fletcher G; American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing. Assessment of functional capacity in clinical and research settings: a scientific statement from the American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology and the Council on Cardiovascular Nursing. Circulation. 2007 Jul 17;116(3):329-43. doi: 10.1161/CIRCULATIONAHA.106.184461. Epub 2007 Jun 18. No abstract available.
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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.
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Myers J, Ahnve S, Froelicher V, Livingston M, Jensen D, Abramson I, Sullivan M, Mortara D. A randomized trail of the effects of 1 year of exercise training on computer-measured ST segment displacement in patients with coronary artery disease. J Am Coll Cardiol. 1984 Dec;4(6):1094-102. doi: 10.1016/s0735-1097(84)80127-8.
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Myers J, Gademan M, Brunner K, Kottman W, Boesch C, Dubach P. Effects of high-intensity training on indices of ventilatory efficiency in chronic heart failure. J Cardiopulm Rehabil Prev. 2012 Jan-Feb;32(1):9-16. doi: 10.1097/HCR.0b013e3182343bdf.
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Myers J, Wagner D, Schertler T, Beer M, Luchinger R, Klein M, Rickli H, Muller P, Mayer K, Schwitter J, Dubach P. Effects of exercise training on left ventricular volumes and function in patients with nonischemic cardiomyopathy: application of magnetic resonance myocardial tagging. Am Heart J. 2002 Oct;144(4):719-25. doi: 10.1067/mhj.2002.124401.
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Sun V, Raz DJ, Kim JY, Melstrom L, Hite S, Varatkar G, Fong Y. Barriers and facilitators of adherence to a perioperative physical activity intervention for older adults with cancer and their family caregivers. J Geriatr Oncol. 2020 Mar;11(2):256-262. doi: 10.1016/j.jgo.2019.06.003. Epub 2019 Jun 14.
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Birtwistle SB, Jones I, Murphy R, Gee I, Watson PM. Family support for physical activity post-myocardial infarction: A qualitative study exploring the perceptions of cardiac rehabilitation practitioners. Nurs Health Sci. 2021 Mar;23(1):227-236. doi: 10.1111/nhs.12806. Epub 2021 Jan 26.
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Arena R, Williams M, Forman DE, Cahalin LP, Coke L, Myers J, Hamm L, Kris-Etherton P, Humphrey R, Bittner V, Lavie CJ; American Heart Association Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Council on Nutrition, Physical Activity and Metabolism. Increasing referral and participation rates to outpatient cardiac rehabilitation: the valuable role of healthcare professionals in the inpatient and home health settings: a science advisory from the American Heart Association. Circulation. 2012 Mar 13;125(10):1321-9. doi: 10.1161/CIR.0b013e318246b1e5. Epub 2012 Jan 30. No abstract available.
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Treat-Jacobson D, McDermott MM, Bronas UG, Campia U, Collins TC, Criqui MH, Gardner AW, Hiatt WR, Regensteiner JG, Rich K; American Heart Association Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Optimal Exercise Programs for Patients With Peripheral Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Jan 22;139(4):e10-e33. doi: 10.1161/CIR.0000000000000623. No abstract available.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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
Reference Type
BACKGROUND
Moore CS, Myers J, Yesavage JA, Fairchild JK. Assessment of physical activity in older adults with cognitive impairment. Submitted, 2022
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.medtechinsight.com/ReportA254.html
U.S. Markets for Peripheral Vascular Stents
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287
Related Info
https://www.accc-cancer.org/docs/documents/meetings/ufo/ufo-2019-prehab-services-tool.pdf
Wilson C, Colombo R. Association of Community Cancer Centers. Making the business case for implementing prehabilitation services
https://www.macmillan.org.uk/_images/prehabilitation-evidence-and-insight-review_tcm9-335025.pdf
Bloom E. Prehabilitation evidence and insight review. Macmillan National Cancer Rehabilitation, 2018.
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287
Centers for Medicare \& Medicaid Services. Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MYE0018APR
Identifier Type: -
Identifier Source: org_study_id
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