Prehabilitation and Rehabilitation in PAD

Official title

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

Overview

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.

Interventions

• 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 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.

Primary outcome measures

• Time to claudication pain [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]

Secondary outcome measures (12)

• Peak VO2 [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• 6-minute walk test (6MWT) [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Walking Impairment Questionnaire (WIQ) [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Peripheral Artery Questionnaire (PAQ) [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Walking [Time frame: Up to 22 weeks]
• Energy expenditure [Time frame: Up to 22 weeks]
• Chair raises [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Upper body strength [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Lower body strength [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Hand grip strength [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Insulin sensitivity [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]
• Lipid panel [Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• VA Palo Alto Health Care System — Palo Alto

Publications

• Correction. Circ Res. 2015 Jun 19;117(1):e12. doi: 10.1161/RES.0000000000000059. No abstract available. PMID 26089368
• Mayfield JA, Reiber GE, Maynard C, Czerniecki J, Sangeorzan B. The epidemiology of lower-extremity disease in veterans with diabetes. Diabetes Care. 2004 May;27 Suppl 2:B39-44. doi: 10.2337/diacare.27.suppl_2.b39. PMID 15113781
• Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018 Aug;275:379-381. doi: 10.1016/j.atherosclerosis.2018.05.033. Epub 2018 May 22. No abstract available. PMID 29843915
• Horvath L, Nemeth N, Feher G, Kives Z, Endrei D, Boncz I. Epidemiology of Peripheral Artery Disease: Narrative Review. Life (Basel). 2022 Jul 12;12(7):1041. doi: 10.3390/life12071041. PMID 35888129
• Garg PK, Liu K, Tian L, Guralnik JM, Ferrucci L, Criqui MH, Tan J, McDermott MM. Physical activity during daily life and functional decline in peripheral arterial disease. Circulation. 2009 Jan 20;119(2):251-60. doi: 10.1161/CIRCULATIONAHA.108.791491. Epub 2008 Dec 31. PMID 19118256
• McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001 Oct 3;286(13):1599-606. doi: 10.1001/jama.286.13.1599. PMID 11585483
• McDermott MM, Liu K, Ferrucci L, Tian L, Guralnik JM, Liao Y, Criqui MH. Greater sedentary hours and slower walking speed outside the home predict faster declines in functioning and adverse calf muscle changes in peripheral arterial disease. J Am Coll Cardiol. 2011 Jun 7;57(23):2356-64. doi: 10.1016/j.jacc.2010.12.038. PMID 21636037
• Hamburg NM, Balady GJ. Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits. Circulation. 2011 Jan 4;123(1):87-97. doi: 10.1161/CIRCULATIONAHA.109.881888. No abstract available. PMID 21200015

Identifiers

NCT: NCT06566976 · MYE0018APR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗