Exercise Rehabilitation for Cardiopulmonary Dysfunction

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Institute for Extracorporeal Life Support

Disqualifiers: Hemodynamic instability, Pregnancy, Transplant awaiting, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercise can aid individuals with heart or lung issues who are on an ECMO machine, which supports blood flow when the heart or lungs function poorly. The goal is to determine if a structured exercise program (exercise rehabilitation) can enhance recovery for these patients, both short-term and long-term. The study includes exercises to build strength and improve daily activities using a special bed that assists with movement. Suitable candidates are adults currently on ECMO and receiving care in specialized intensive care units for lung or heart problems. As an Early Phase 1 trial, this research aims to understand how exercise rehabilitation works in people, offering participants the chance to contribute to groundbreaking insights.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this exercise rehabilitation program is safe for patients with cardiopulmonary dysfunction?

Research shows that exercise programs are generally safe for people with heart conditions. One study reported a case of cardiac arrest, but it was quickly treated. This indicates that while rare events can occur, they are often manageable. Exercise programs are usually well-tolerated and can improve heart and lung function. These programs often help people with serious heart issues regain strength and mobility. Overall, exercise rehabilitation aims to safely support recovery and improve quality of life by enhancing physical abilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment for cardiopulmonary dysfunction because it incorporates high-intensity exercise tailored to each individual's tolerance, aiming to maximize strength and functionality. Unlike traditional rehabilitation methods, this approach utilizes the VitalGo Total Lift Bed, which allows for vertical positioning to enhance hemodynamic responses during activities like strength training and daily tasks. This innovative combination could lead to improved outcomes in mobility and overall recovery compared to standard care options.

What evidence suggests that exercise rehabilitation is effective for cardiopulmonary dysfunction?

Studies have shown that exercise rehabilitation can greatly enhance heart and lung function. For patients with serious heart or lung conditions, such as those treated with ECMO, exercise rehabilitation rebuilds muscle strength and movement. Research indicates that exercise programs improve heart health and aid recovery by enhancing lung function. This rehabilitation also eases daily activities, helping patients become stronger and more active. Overall, exercise rehabilitation offers a promising way to improve both short-term and long-term health for those with severe heart and lung issues. Participants in this trial will join an exercise group that completes the highest intensity exercise and activity as tolerated to maximize strength, function, and mobility progression. ^{3 6 7 8 9}

Who Is on the Research Team?

Linda E Sousse, PhD, MBA

Principal Investigator

Institute for Extracorporeal Life Support

Are You a Good Fit for This Trial?

This trial is for patients with severe heart and lung problems who are being treated with a life support system called ECMO. It's designed to see if they can benefit from a structured exercise program.

Inclusion Criteria

Richmond Agitation and Sedation Scale (RASS) greater than or equal to a score of -2 or greater

I am admitted to the LRICU or CVICU.

I am on a heart-lung machine for heart/lung problems.

Exclusion Criteria

I am considered medically unstable by my doctors.

Pregnant or breast feeding

Anticipated transfer to another hospital within 72 hours

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Rehabilitation

Participants engage in a structured exercise and rehabilitation program to improve strength, function, and out-of-bed activity

3 months

Regular sessions as tolerated

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Rehabilitation

Trial Overview

The study tests whether mobility exercises and resistance training can improve short-term and long-term health outcomes in patients on ECMO due to severe cardiopulmonary dysfunction.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 2 Interventions

The exercise group will complete the highest intensity exercise and activity as tolerated to maximize their progression of strength, function, and out of bed. This group will also be utlizing the VitalGo Total Lift Bed (TLB) V5 for vertical positioning to provide a better potential for hemodynamic response to activities to include: strength training, mobility tasks, and functional activities like Activities of Daily Living (ADL).

Who Is Running the Clinical Trial?

Institute for Extracorporeal Life Support

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

Pulmonary rehabilitation significantly enhances muscle function and exercise tolerance in patients with chronic obstructive pulmonary disease (COPD), providing benefits that complement traditional medication.

A tailored, multidisciplinary approach is essential for effective pulmonary rehabilitation, but the challenge remains in sustaining these benefits once the program concludes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation. Troosters, T., Demeyer, H., Hornikx, M., et al.[2018]

Exercise-based rehabilitation for heart failure does not significantly affect short-term mortality rates but does reduce hospital admissions and improves health-related quality of life, as shown in a systematic review of 33 trials involving 4740 participants.

There is a trend suggesting that exercise may lower mortality rates in the long term (over one year), and the benefits of exercise training appear consistent across different patient characteristics, including age and severity of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based rehabilitation for heart failure. Taylor, RS., Sagar, VA., Davies, EJ., et al.[2023]

Exercise training significantly improves exercise performance and quality of life for patients with both chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF), addressing common symptoms like breathlessness and fatigue.

Incorporating CHF patients into pulmonary rehabilitation (PR) programs, which are standard for COPD, could enhance access to exercise rehabilitation and provide effective treatment, as both conditions share similar symptoms and can be trained together safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing the model of pulmonary rehabilitation for chronic heart failure. Evans, RA.[2011]

Citations

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pmc.ncbi.nlm.nih.gov

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Effectiveness of Cardiac Rehabilitation in Enhancing ...

1. Exercise Training. The exercise training component began with a comprehensive initial assessment, including cardiopulmonary exercise testing ...

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Long-term patient outcomes from a multidisciplinary ...

Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane ... cardiovascular disease and renal dysfunction. J. Cardiopulm. Rehabil. Prev ...

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Benefits of Cardiac Rehabilitation: Mechanisms to Restore ...

Reduced peak exercise stroke volume is also common in CVD, especially with systolic dysfunction. The reduction in peak exercise stroke ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06792617

Exercise Rehabilitation in Patients With Severe ...

... disease (that is, the drug's effectiveness). ... Exercise Rehabilitation in Patients With Severe Cardiopulmonary Dysfunction on Extracorporeal Life Support.

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frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1120665/full

Effects of different rehabilitation modality on ...

In summary, exercise rehabilitation, as the core element of cardiac rehabilitation, can help improve patients' ventilatory function, cardiopulmonary endurance, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3145438/

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... cardiopulmonary rehabilitation and exercise training programs are ... Cardiac rehabilitation in patients with severe ischemic left ventricular dysfunction.

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sciencedirect.com

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A Clinical Guide for Assessment and Prescription of ...

The gold-standard assessment for aerobic exercise capacity is a cardiopulmonary exercise test (CPET) conducted on either a treadmill or cycle ergometer with gas ...

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Safety of Exercise Training for Cardiac Patients

In 1 case, cardiac arrest by “vagal reflex” occurred during the recovery period but quickly responded to short cardiopulmonary resuscitation; in another case, ...

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The effects of CPET-guided cardiac rehabilitation on ...

CPET is an objective and accurate method for assessing cardiopulmonary function in patients after PCI and is relatively safe. For older CHD ...