Cardiac Rehabilitation for Stroke Survivors

(SRP-CROSS Trial)

Overseen By Hayk Petrosyan, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Subarachnoid hemorrhage, Intracranial aneurysm, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a cardiac rehabilitation program can help stroke patients recover better. It aims to see if these patients have fewer hospital visits, fewer repeat strokes, and lower death rates by adding this program to their usual care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Cardiac rehabilitation program, Cardiac Conditioning, Stroke-Specific Cardiac Rehabilitation, Modified Cardiac Rehabilitation for stroke survivors?

Cardiac rehabilitation programs, which include exercise and conditioning, have been shown to improve outcomes like functional capacity and quality of life in patients with heart conditions. Although these programs are primarily used for heart patients, the principles of exercise and conditioning could potentially benefit stroke survivors by improving their overall health and recovery. ^{1 2 3 4 5}

Is cardiac rehabilitation safe for stroke survivors?

Research suggests that cardiac rehabilitation, which includes structured exercise programs, is generally safe for stroke survivors. Studies have shown that it can improve cardiovascular endurance and functional strength without significant adverse events. ^{6 7 8 9 10}

How is cardiac rehabilitation unique for stroke survivors?

Cardiac rehabilitation for stroke survivors is unique because it adapts a structured exercise program, typically used for heart disease patients, to improve cardiovascular endurance and functional strength in stroke survivors. This approach is novel as stroke is not usually included in cardiac rehabilitation programs, yet it shows significant improvements in physical function and quality of life for these patients. ^{2 5 8 11 12}

Research Team

Sara J Cuccurullo, MD

Principal Investigator

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Talya K Fleming, MD

Principal Investigator

Hackensack Meridian Health - JFK Johnson Rehabilitation Institute

Eligibility Criteria

This trial is for stroke survivors who are 18 or older, can follow commands and communicate discomfort, have been admitted to a rehab facility post-stroke, and cleared by a cardiologist. They must be able to stand and walk at least 10 feet with assistance if needed. Those with certain other brain conditions or medical issues that prevent participation in the study, unable to meet study requirements, non-English speakers, or diagnosed beyond 45 days post-stroke are excluded.

Inclusion Criteria

I can understand simple instructions and express when I'm in pain or uncomfortable.

I am 18 years old or older.

Signed informed consent form

Exclusion Criteria

I have a brain bleed or abnormal blood vessels in my brain.

Medical disorders that preclude participation in the study as determined by the Principal Investigator

Patient considered unable to comply with study requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a traditional medically supervised center-based cardiac rehabilitation program, including 36 sessions of a progressive exercise program and educational sessions for cardiovascular disease risk factors

12 weeks

36 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of functional recovery and health outcomes

1 year

Treatment Details

Interventions

• Cardiac rehabilitation program

Trial Overview The SRP-CROSS trial is testing whether adding cardiac rehabilitation to standard care helps improve recovery after a stroke. It looks at whether this approach reduces hospital readmissions, recurrent strokes, and death rates among these patients.

Participant Groups

Group I: Cardiac rehabilitation group Experimental Treatment 1 Intervention

Traditional 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.

Group II: Standard of care Active Control 1 Intervention

Depending 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.

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

The Cardiovascular Institute of New Jersey at Rutgers Robert Wood Johnson Medical School

Collaborator

Trials

1

Recruited

110+

Findings from Research

A structured cardiac rehabilitation program significantly improved long-term survival rates in low-risk male patients under 65 who had suffered an acute myocardial infarction, with a 10-year survival rate of 91.8% compared to 81.7% in the control group.

The rehabilitation program also reduced the incidence of non-fatal complications, unstable angina, and the need for coronary interventions, indicating its effectiveness in improving overall health outcomes after a heart attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac rehabilitation in patients with myocardial infarction: a 10-year follow-up study]. Maroto Montero, JM., Artigao Ramírez, R., Morales Durán, MD., et al.[2006]

Only 60% of cardiac rehabilitation programs in Ontario include stroke survivors, and they represent less than 5% of total enrollment, indicating a significant gap in access for these individuals.

Despite lower initial exercise capacity, stroke survivors showed comparable improvements in peak oxygen uptake and anaerobic threshold after participating in cardiac rehabilitation, similar to those with cardiac diagnoses only.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation after stroke-need and opportunity. Tang, A., Closson, V., Marzolini, S., et al.[2018]

Cardiac rehabilitation, particularly exercise-based programs, has been shown to improve outcomes for patients who have experienced a myocardial infarction, enhancing functional capacity, psychosocial well-being, and health knowledge.

These rehabilitation programs are generally safe, especially when monitored with telemetry, and the review also highlights the potential benefits for patients beyond those with a history of myocardial infarction, including home-based rehabilitation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. Greenland, P., Chu, JS.[2019]

Cardiac rehabilitation has evolved from focusing solely on recovery after a heart attack to a more comprehensive program that benefits a wider range of patients with various cardiovascular issues.

The review highlights that both exercise training and comprehensive cardiac rehabilitation positively impact cardiovascular outcomes, including clinical results and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise and cardiac rehabilitation on cardiovascular outcomes. Ades, PA., Green, NM., Coello, CE.[2019]

In a study of 100 patients recovering from acute myocardial infarction, those who participated in supervised cardiac rehabilitation showed significant improvements in heart electrical activity, as measured by signal-averaged electrocardiogram (SAECG), compared to those who only received standard care.

After five days of rehabilitation, the percentage of patients with abnormal SAECG indices (indicating late potential) dropped dramatically from 64% to 20%, highlighting the efficacy of supervised exercise training in enhancing cardiac function post-heart attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Hospital-Based Cardiac Rehabilitation on Signal Average ECG Parameters of the Heart After Myocardial Infarction. Jorat, M., Raafat, S., Ansari, Z., et al.[2020]

Patients who have had a stroke are at high risk for repeat strokes and coronary artery disease, but structured exercise programs that include both aerobic and resistance training can help prevent these complications.

Integrating traditional stroke rehabilitation with cardiac rehabilitation through an automatic referral process can significantly improve secondary prevention efforts and enhance recovery outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Individuals With Stroke Into Cardiac Rehabilitation Following Traditional Stroke Rehabilitation: Promoting a Continuum of Care. Marzolini, S.[2019]

A 12-week interdisciplinary rehabilitation program for 439 patients after acute coronary syndrome significantly improved functional capacity, as shown by increases in exercise test performance and walking distance.

The program also led to healthier eating habits, reduced body weight, and decreased abdominal fat, highlighting its effectiveness in enhancing overall health and lifestyle in patients with stable ischemic heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of an interdisciplinary program combining aerobic interval training and dynamic strength in acute coronary syndrome]. Arias Labrador, E., Vilaró Casamitjana, J., Blanco Díaz, S., et al.[2022]

Integrating stroke survivors into a 12-week exercise-based cardiac rehabilitation program significantly improved their cardiovascular endurance, with participants increasing their 6-minute walk test distance by an average of 61.92 meters and improving functional strength as measured by the five times sit to stand test.

The majority of participants (83%) continued exercising after the program, indicating that exercise-based cardiac rehabilitation not only enhances physical function but also positively impacts the quality of life for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Survivors of Stroke Into Exercise-Based Cardiac Rehabilitation Improves Endurance and Functional Strength. Regan, EW., Handlery, R., Stewart, JC., et al.[2021]

The feasibility study involved 32 participants with mild-to-moderate strokes, showing that an adapted cardiac rehabilitation program was well-accepted, with an 80% attendance rate and positive changes in various health measures after six weeks.

The study indicated that the incremental shuttle walk test (ISWT) was an effective outcome measure for assessing improvements in cardiorespiratory fitness, and only one adverse event was reported, suggesting the program's safety for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted cardiac rehabilitation for people with sub-acute, mild-to-moderate stroke: a mixed methods feasibility study. Clague-Baker, N., Robinson, T., Gillies, CL., et al.[2022]

The early initiation of a stroke-integrated Cardiac Rehabilitation program was found to be safe, with no adverse or serious adverse events reported among participants, indicating a low risk associated with the intervention.

The program demonstrated good feasibility, with a recruitment rate of 53% from eligible stroke admissions and high attendance rates (94% in Phase 1 and 89.5% in Phase 2) for cardiorespiratory fitness training sessions, suggesting that participants were engaged and satisfied with the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is early initiated cardiorespiratory fitness training within a model of stroke-integrated cardiac rehabilitation safe and feasible? Machado, N., Williams, G., Olver, J., et al.[2023]

A study of 256 patients with coronary disease showed that a 12-month exercise-based cardiac rehabilitation program significantly improved various cardiovascular risk factors, including lipid profiles and blood pressure, with these improvements maintained over time.

Despite initial improvements, body mass index changes lost statistical significance by the 6-month follow-up, indicating the need for ongoing strategies to sustain weight management in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term effects of a cardiac rehabilitation program in the control of cardiovascular risk factors]. Magalhães, S., Viamonte, S., Miguel Ribeiro, M., et al.[2013]

This randomized controlled trial will assess the effects of a 16-week cardiovascular rehabilitation program on various health outcomes in 40 patients with chronic ischemic stroke, comparing an intervention group (IG) with a control group (CG).

The study aims to demonstrate that the IG, which will engage in aerobic and muscle-strengthening exercises, will show significant improvements in functional capacity and echocardiographic measures, potentially enhancing quality of life post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of an exercise program on cardiac remodeling and functional capacity in patients with stroke (CRONuS trial): study protocol for a randomized controlled trial. da Silva Rodrigues, JC., Luvizutto, GJ., da Costa, RDM., et al.[2020]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Cardiac rehabilitation in patients with myocardial infarction: a 10-year follow-up study]. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation after stroke-need and opportunity. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of exercise and cardiac rehabilitation on cardiovascular outcomes. [2019]

5. India pubmed.ncbi.nlm.nih.gov

The Impact of Hospital-Based Cardiac Rehabilitation on Signal Average ECG Parameters of the Heart After Myocardial Infarction. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Integrating Individuals With Stroke Into Cardiac Rehabilitation Following Traditional Stroke Rehabilitation: Promoting a Continuum of Care. [2019]

7. Spain pubmed.ncbi.nlm.nih.gov

[Effects of an interdisciplinary program combining aerobic interval training and dynamic strength in acute coronary syndrome]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Integrating Survivors of Stroke Into Exercise-Based Cardiac Rehabilitation Improves Endurance and Functional Strength. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adapted cardiac rehabilitation for people with sub-acute, mild-to-moderate stroke: a mixed methods feasibility study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Is early initiated cardiorespiratory fitness training within a model of stroke-integrated cardiac rehabilitation safe and feasible? [2023]

11. Portugal pubmed.ncbi.nlm.nih.gov

[Long-term effects of a cardiac rehabilitation program in the control of cardiovascular risk factors]. [2013]

12. England pubmed.ncbi.nlm.nih.gov

Influence of an exercise program on cardiac remodeling and functional capacity in patients with stroke (CRONuS trial): study protocol for a randomized controlled trial. [2020]