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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Exercise Rehabilitation for cardiopulmonary dysfunction?

Research shows that pulmonary rehabilitation, which includes exercise training, improves exercise tolerance and reduces breathlessness in patients with chronic lung diseases like COPD. This suggests that exercise rehabilitation can help improve physical fitness and breathing in people with cardiopulmonary issues. ^{1 2 3 4 5}

Is exercise rehabilitation safe for people with heart and lung conditions?

Exercise rehabilitation is generally considered safe for people with heart and lung conditions, as it is designed to improve muscle function and exercise tolerance. Safety concerns are addressed by tailoring programs to individual needs and monitoring patients during rehabilitation. ^{6 7 8 9 10}

How does the treatment Exercise Rehabilitation differ from other treatments for cardiopulmonary dysfunction?

Exercise Rehabilitation is unique because it uses tailored exercise programs to improve exercise capacity and quality of life in patients with cardiopulmonary dysfunction, unlike standard treatments that may not focus on physical activity. It incorporates various exercise modalities, such as aerobic and strength training, and can be adapted to individual needs, making it suitable for patients with both chronic heart failure and chronic obstructive pulmonary disease. ^{2 5 11 12 13}

What is the purpose of this trial?

Short-term and long-term consequences of severe cardiac and/or lung dysfunction can be increased use of sedation, prolonged bedrest and immobility causing severe loss of muscle mass which could be a risk for muscle weakness, osteoporosis, and lowered endurance. The goal of this study is to show how a structured rehabilitation program can exhibit better short-term and long-term outcomes on patients who are treated with extracorporeal membrane oxygenation (ECMO).

Research Team

Linda E Sousse, PhD, MBA

Principal Investigator

Institute for Extracorporeal Life Support

Eligibility Criteria

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

I am admitted to the LRICU or CVICU.

Exclusion Criteria

I am considered medically unstable by my doctors.

Pregnant or breast feeding

Anticipated transfer to another hospital within 72 hours

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Variability in Quality of Life Outcomes Following a Pulmonary Rehabilitation Program in Patients With COPD. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

[Effects of pulmonary rehabilitation in patients with chronic respiratory failure]. [2006]

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

Long-Term Benefits of Pulmonary Rehabilitation in Patients With COPD: A 2-Year Follow-Up Study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial to assess the influence of a three months training program (gym-based individualized vs. calisthenics-based non-invidualized) in COPD-patients. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Effect of once weekly pulmonary rehabilitation on exercise tolerance in patients with chronic lung disease. [2019]

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

Pulmonary rehabilitation. [2018]

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

Safety considerations during cardiac and pulmonary rehabilitation program. [2016]

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

Exercise-based rehabilitation for heart failure. [2023]

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

Dyspnea During In-Hospital Rehabilitation as a Predictor of Rehospitalization and Mortality in Patients With Acute Heart Failure. [2020]

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

Impact of supervised exercise rehabilitation on daily physical activity of cardiopulmonary patients. [2018]

11. China pubmed.ncbi.nlm.nih.gov

[Preliminary report of using cardiopulmonary exercise testing guide exercise rehabilitation in patients with chronic heart failure]. [2018]

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

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

13. Spain pubmed.ncbi.nlm.nih.gov

[Exercise training in chronic pulmonary disease]. [2019]