Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

Official title

Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors

Overview

This study examines the effectiveness of the cardiac rehabilitation program for stroke patients. The study will examine if patients with stroke, who receive cardiac rehabilitation in addition to their standard of care treatments, demonstrate improved recovery of function. It will also examine if these patients have reduced hospital readmission, reduced rate of recurrent stroke, and mortality.

Interventions

• Other Cardiac rehabilitation program
  The cardiac rehabilitation program is an outpatient exercise intervention consisting of 36 sessions (30-50 minutes) of a progressive exercise program. Participants are closely monitored throughout the sessions using a telemetry monitor and are supervised by a team of cardiac rehabilitation nurses and exercise physiologists. In addition to the exercise program, participants will receive educational sessions for cardiovascular disease (CVD) risk factors including: 1) Diet/Nutrition, 2) Smoking ces

Primary outcome measures

• 6-Minute Walk Test (6MWT) [Time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.]

Secondary outcome measures (12)

• MET-min - (Metabolic Equivalent of Task - minutes) [Time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.]
• AM-PAC - (Activity Measure for Post Acute Care) [Time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.]
• 10-Minute Walk Test (10MWT) [Time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.]
• MoCA - (Montreal Cognitive Assessment) [Time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.]
• SS-QOL - (Stroke specific Quality of Life) [Time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke]
• PHQ-9 - (Patient Health Questionnaire -9) [Time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke]
• All-cause hospital readmission [Time frame: 1-year post-stroke]
• Recurrent stroke rate [Time frame: 1-year post stroke]
• All-cause mortality rate [Time frame: 1-year post stroke]
• AM-PAC - (Activity Measure for Post Acute Care) [Time frame: 1-year post stroke]
• SS-QOL - (Stroke specific Quality of Life) [Time frame: 1-year post stroke]
• mRS - (Modified Rankin Scale) [Time frame: Change from Baseline (30 days post stroke) to 120 days post stroke]

Eligibility criteria

Inclusion criteria

• 18 years or older
• Stroke diagnosis (ischemic or hemorrhagic) / radiologic evidence of acute stroke
• Medically cleared by a cardiologist for participation in the cardiac rehabilitation program with no contraindications to cardiac rehabilitation per American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines
• Ability to transfer on/off the recumbent bike with or without an assistive device safely, with or without assistance from another person
• Ability to follow simple commands and communicate pain or distress
• Admission to an Inpatient Rehabilitation Facility post-stroke
• Signed informed consent form

Exclusion criteria

• Presence of subarachnoid hemorrhage, intracranial aneurysm, intracranial hemangioma, or arteriovenous malformation
• Medical disorders that preclude participation in the study as determined by the Principal Investigator.
• Inability to have baseline assessment within 60 days post-stroke diagnosis
• Patient considered unable to comply with study requirements
• Known terminal illness with life expectancy less than 1 year
• Compliant diagnosis eligible for traditional cardiac rehabilitation covered by insurance
• Unable to understand/speak English

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

• Hackensack Meridian Health - JFK Johnson Rehabilitation Institute — Edison

Publications

• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044. PMID 26764059
• Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for str PMID 24846875
• Cuccurullo SJ, Fleming TK, Kostis WJ, Greiss C, Gizzi MS, Eckert A, Ray AR, Scarpati R, Cosgrove NM, Beavers T, Cabrera J, Sargsyan D, Kostis JB. Impact of a Stroke Recovery Program Integrating Modified Cardiac Rehabilitation on All-Cause Mortality, Cardiovascular Performance and Functional Performance. Am J Phys Med Rehabil. 2019 Nov;98(11):953-963. doi: 10.1097/PHM.0000000000001214. PMID 31634208
• Cuccurullo SJ, Fleming TK, Kostis JB, Greiss C, Eckert A, Ray AR, Scarpati R, Zinonos S, Gizzi M, Cosgrove NM, Cabrera J, Oh-Park M, Kostis WJ. Impact of Modified Cardiac Rehabilitation Within a Stroke Recovery Program on All-Cause Hospital Readmissions. Am J Phys Med Rehabil. 2022 Jan 1;101(1):40-47. doi: 10.1097/PHM.0000000000001738. PMID 33657031
• English C, Healy GN, Coates A, Lewis L, Olds T, Bernhardt J. Sitting and Activity Time in People With Stroke. Phys Ther. 2016 Feb;96(2):193-201. doi: 10.2522/ptj.20140522. Epub 2015 Jun 25. PMID 26112254
• Fini NA, Holland AE, Keating J, Simek J, Bernhardt J. How Physically Active Are People Following Stroke? Systematic Review and Quantitative Synthesis. Phys Ther. 2017 Jul 1;97(7):707-717. doi: 10.1093/ptj/pzx038. PMID 28444348
• Globas C, Becker C, Cerny J, Lam JM, Lindemann U, Forrester LW, Macko RF, Luft AR. Chronic stroke survivors benefit from high-intensity aerobic treadmill exercise: a randomized control trial. Neurorehabil Neural Repair. 2012 Jan;26(1):85-95. doi: 10.1177/1545968311418675. Epub 2011 Sep 1. PMID 21885867
• Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16. PMID 21576654

Identifiers

NCT: NCT05651945 · Pro2022-0785

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗