What side effects are associated with this type of intervention?

The most common treatments for stroke involving structured exercise, education, and counseling generally have minimal side effects. However, patients may experience muscle soreness, fatigue, or minor injuries from physical activity. Additionally, there may be psychological effects such as frustration or anxiety during the rehabilitation process. It is important for these programs to be supervised by healthcare professionals to minimize risks and ensure patient safety.

What prior FDA approvals exist?

The FDA has approved various treatments for stroke, primarily focusing on pharmacologic interventions such as tissue plasminogen activator (tPA) for acute ischemic stroke. However, non-pharmacologic treatments like structured exercise programs, education, and counseling, similar to those studied in cardiac rehabilitation programs, are also essential for stroke recovery. These programs aim to improve cardiovascular health and physical function, reduce hospital readmissions, and enhance overall quality of life. While specific FDA approvals for such rehabilitation programs may not be detailed, their importance in comprehensive stroke management is well-recognized.

What other types of research exist?

Promising novel alternatives to traditional Cardiac Rehabilitation Programs for stroke patients include: 1) Home-based exercise programs utilizing wearable technology and telehealth coaching, which have shown effectiveness in improving physical function and cardiovascular health. 2) Virtual reality (VR) and gamified rehabilitation exercises that enhance patient engagement and adherence to exercise regimens. 3) Personalized rehabilitation plans using artificial intelligence (AI) to tailor exercise and recovery programs based on individual patient data and progress. 4) Integrative approaches combining physical exercise with cognitive training to address both physical and mental aspects of stroke recovery.

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Cardiac Rehabilitation for Stroke Survivors (SRP-CROSS Trial)

N/A

Recruiting

Led By Sara J Cuccurullo, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year post stroke

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed for cardiac rehabilitation programs in this summary, such interventions may include general risks like muscle soreness or fatigue from exercise. The program should be tailored to each patient's abilities following their stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year post stroke

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year post stroke

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year post stroke for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-Minute Walk Test (6MWT)

Secondary study objectives

10-Minute Walk Test (10MWT)

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

All-cause hospital readmission

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cardiac rehabilitation groupExperimental Treatment1 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 careActive Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cardiac rehabilitation programs for stroke patients typically include structured exercise, education, and counseling. Structured exercise helps improve cardiovascular health by enhancing blood flow, reducing blood pressure, and increasing overall physical endurance, which can mitigate the risk of recurrent strokes. Education provides patients with knowledge about stroke risk factors, healthy lifestyle choices, and medication adherence, empowering them to manage their health proactively. Counseling offers psychological support, helping patients cope with the emotional aftermath of a stroke and encouraging adherence to rehabilitation protocols. Together, these components work synergistically to enhance recovery, reduce hospital readmissions, and lower mortality rates, making them vital for stroke patients.