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StrokeSRP-CROSSNCT05651945

Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

A study testing Cardiac rehabilitation program in people with Stroke and Cerebrovascular Accident, run by Hackensack Meridian Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Cerebrovascular Accident
What is being tested?
Cardiac rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
20 Jan 2023to 20 Jan 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

    Edison, New Jersey, 08820

    Hayk Petrosyan, PhD, 732-321-7000 ext. 65979, hayk.petrosyan@hmhn.org

    Recruiting

Other trials in United States

About this study

Official title: Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors

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.

Being tested
Cardiac rehabilitation program
Keywords
cardiac rehabilitation, stroke, stroke rehabilitation, stroke recovery, exercise, cardiovascular disease, cardiovascular function, cognitive function, physical function, neurorehabilitation, transition of care post stroke
Medical subject headings
Stroke, Motor Activity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac rehabilitation programOther

    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 cessation, 3) Physical activity, 4) Medication management/adherence and 5) Behavior change. As a part of the program, based on the initial assessment results, patients are referred to a rehabilitation psychologist or a dietician for consultation and evaluation if needed. In addition, participants will also receive their standard of care therapies as prescribed by their treating physicians.

Study groups in NCT05651945
Study groupRoleWhat they receive
Cardiac rehabilitation groupExperimentalTraditional medically supervised center-based cardiac rehabilitation program; including 36 sessions (30-50 minutes) of a progressive exercise program and educational sessions for cardiovascular disease (CVD) risk factors.
Receives: Other: Cardiac rehabilitation program
Standard of careNo interventionDepending on functional deficits, conventional rehabilitation therapies can include physical therapy, occupational therapy, and/or speech therapy sessions with 2-3 visits per week. Participants will receive their standard of care therapies as prescribed by their treating physicians.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-Minute Walk Test (6MWT)

    Mean change in 6MWT score from baseline (30 days post-stroke) to 120 days post-stroke.

    Measured: Change from Baseline (30 days post-stroke) to 120 days post-stroke.

Secondary outcomes (13)
  1. MET-min - (Metabolic Equivalent of Task - minutes)

    Mean change in MET-min score from baseline (30 days post-stroke) to 120 days post-stroke.

    Measured: Change from Baseline (30 days post-stroke) to 120 days post-stroke.

  2. AM-PAC - (Activity Measure for Post Acute Care)

    Mean change in AM-PAC score from baseline (30 days post-stroke) to 120 days post-stroke. AM-PAC is a questionnaire that evaluates functional outcomes across three domains: basic mobility, daily activity, and applied cognitive. Standardized scores range from -11.95 to 104.9 for basic mobility, from -2.73 to 115.4 for daily activities, and from 6.84 to 68.28 for applied cognition with higher scores representing a better function.

    Measured: Change from Baseline (30 days post-stroke) to 120 days post-stroke.

  3. 10-Minute Walk Test (10MWT)

    Mean change in 10MWT score from baseline (30 days post-stroke) to 120 days post-stroke.

    Measured: Change from Baseline (30 days post-stroke) to 120 days post-stroke.

  4. MoCA - (Montreal Cognitive Assessment)

    Mean change in MoCA score from baseline (30 days post-stroke) to 120 days post-stroke. MoCA is a 16-item test assessing multiple cognitive domains with a score range from 0-30 with higher scores representing a better function.

    Measured: Change from Baseline (30 days post-stroke) to 120 days post-stroke.

  5. SS-QOL - (Stroke specific Quality of Life)

    Mean change in SS-QOL score from baseline (30 days post-stroke) to 120 days post-stroke. SS-QOL is a self-reported questionnaire containing 49 item questions covering 12 domains with a score range of 49-245 with higher scores representing better function.

    Measured: Change from Baseline (30 days post-stroke) to 120 days post-stroke

  6. PHQ-9 - (Patient Health Questionnaire -9)

    Mean change in PHQ-9 score from baseline (30 days post-stroke) to 120 days post-stroke. The PHQ-9 is a self-administered questionnaire designed to diagnose and evaluate depression with a score range 0-27.

    Measured: Change from Baseline (30 days post-stroke) to 120 days post-stroke

  7. All-cause hospital readmission

    All-cause hospital readmission rates at 1-year post-stroke

    Measured: 1-year post-stroke

  8. Recurrent stroke rate

    Recurrent stroke rates at 1-year post stroke

    Measured: 1-year post stroke

  9. All-cause mortality rate

    All-cause mortality rates at 1-year post stroke

    Measured: 1-year post stroke

  10. AM-PAC - (Activity Measure for Post Acute Care)

    Mean change in AM-PAC score from baseline (30 days post stroke) to 1-year post stroke. AM-PAC is a questionnaire that evaluates functional outcomes across three domains: basic mobility, daily activity, and applied cognitive. Standardized scores range from -11.95 to 104.9 for basic mobility, from -2.73 to 115.4 for daily activities, and from 6.84 to 68.28 for applied cognition with higher scores representing a better function.

    Measured: 1-year post stroke

  11. SS-QOL - (Stroke specific Quality of Life)

    Mean change in SS-QOL score from baseline (30 days post stroke) to 1-year post stroke. SS-QOL is a self-reported questionnaire containing 49 item questions covering 12 domains with a score range of 49-245 with higher scores representing better function.

    Measured: 1-year post stroke

  12. mRS - (Modified Rankin Scale)

    Mean change in mRS score from baseline (30 days post stroke) to 120 days post stroke. The mRS is a questionnaire to assess the level of disability and functional independence in daily activities with reference to pre-stroke activities. The scale is scored 0-6 where 0 indicates lack of symptoms and the score 6 indicates death.

    Measured: Change from Baseline (30 days post stroke) to 120 days post stroke

  13. Picture Your Plate (PYP)

    Mean change in PYP score from baseline (30 days post stroke) to 120 days post stroke. Picture Your Plate is a brief 48-question dietary assessment questionnaire with a total score ranging from 0 to 96 with higher scores representing an unhealthy diet.

    Measured: Change from Baseline (30 days post stroke) to 120 days post stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2022
  2. Study start20 Jan 2023
  3. Primary completion20 Jan 2028 (estimated)
  4. Study completion20 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05651945
Sponsor's protocol ID
Pro2022-0785
Acronym
SRP-CROSS
Status last verified
Sep 2026
First submitted
7 Dec 2022
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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 stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 21576654
  • MacKay-Lyons M, Billinger SA, Eng JJ, Dromerick A, Giacomantonio N, Hafer-Macko C, Macko R, Nguyen E, Prior P, Suskin N, Tang A, Thornton M, Unsworth K. Aerobic Exercise Recommendations to Optimize Best Practices in Care After Stroke: AEROBICS 2019 Update. Phys Ther. 2020 Jan 23;100(1):149-156. doi: 10.1093/ptj/pzz153.

    PubMed 31596465
  • Marzolini S. Including Patients With Stroke in Cardiac Rehabilitation: BARRIERS AND FACILITATORS. J Cardiopulm Rehabil Prev. 2020 Sep;40(5):294-301. doi: 10.1097/HCR.0000000000000540.

    PubMed 32868656
  • Marzolini S, Danells C, Oh PI, Jagroop D, Brooks D. Feasibility and Effects of Cardiac Rehabilitation for Individuals after Transient Ischemic Attack. J Stroke Cerebrovasc Dis. 2016 Oct;25(10):2453-63. doi: 10.1016/j.jstrokecerebrovasdis.2016.06.018. Epub 2016 Jul 11.

    PubMed 27425176
  • Marzolini S, Fong K, Jagroop D, Neirinckx J, Liu J, Reyes R, Grace SL, Oh P, Colella TJF. Eligibility, Enrollment, and Completion of Exercise-Based Cardiac Rehabilitation Following Stroke Rehabilitation: What Are the Barriers? Phys Ther. 2020 Jan 23;100(1):44-56. doi: 10.1093/ptj/pzz149.

    PubMed 31588512
  • Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.

    PubMed 26673558
  • Murphy SL, Kochanek KD, Xu J, Arias E. Mortality in the United States, 2020. NCHS Data Brief. 2021 Dec;(427):1-8.

    PubMed 34978528
  • Pang MY, Charlesworth SA, Lau RW, Chung RC. Using aerobic exercise to improve health outcomes and quality of life in stroke: evidence-based exercise prescription recommendations. Cerebrovasc Dis. 2013;35(1):7-22. doi: 10.1159/000346075. Epub 2013 Feb 14.

    PubMed 23428993

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac rehabilitation program in people with Stroke and Cerebrovascular Accident, run by Hackensack Meridian Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hayk Petrosyan, Ph.D. (732-321-7000 ext. 65979, hayk.petrosyan@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Minute Walk Test (6MWT) (time frame: Change from Baseline (30 days post-stroke) to 120 days post-stroke.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05651945, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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