Exercise Rehabilitation in Patients with Severe Cardiopulmonary Dysfunction on Extracorporeal Life Support

Early Phase 1

• Conditions: ExtraCorporeal Membrane Oxygenation (ECMO); Cardiopulmonary Function; Rehabilitation

• Registration Number: NCT06792617
• Lead Sponsor: Institute for Extracorporeal Life Support

Brief Summary

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).

Detailed Description

I.Introduction

The long-term consequences of severe cardiac and/or lung dysfunction include: the increased use of sedation, increased parameters on the ventilator, and incidence of delirium. These sequelae are all associated with prolonged bed rest and immobility, which causes severe loss of muscle mass and bone density. Significant loss of muscle and bone causes patients to be at risk for muscle weakness, osteoporosis, and lowered endurance. Extracorporeal membrane oxygenation (ECMO) is a strategy used to mitigate severe cardiac and/or lung dysfunction. Briefly, during ECMO, blood passes through a mechanical circuit and external oxygenator, which removes carbon dioxide and adds oxygen. Blood is then re-infused by a pump to provide cardiovascular support upon return to the body. It provides gas exchange for patients when their own heart and/or lungs are unable to function adequately, and it has been shown to improve survival rates and outcomes in patients with severe respiratory failure.

The investigators hypothesize that patients with cardiac and/or lung dysfunction treated with ECMO who participate in this rehabilitation program will exhibit better short-term and long-term outcomes than patients who have not participated in this rehabilitation program. There are four aims to this study: patients who participate in this rehabilitation program will exhibit a (1) significantly increased rate of weaning from ECMO and from mechanical ventilation, (2) significantly decreased rate of major post-ECMO complications, (3) significantly increased time exercising and improvement and completion of activities of daily living \[ADL\], and (4) significant increase in quality of life, long-term outcomes, short physical performance battery, and rehabilitation outcomes.

II. Background This study's intended accomplishment will be to establish a multidisciplinary, structured exercise and rehabilitation program for patients on ECMO so that days on an ECMO circuit are reduced, quality of life is improved, post-ECMO complications are decreased, and positive long-term outcomes are increased. This is important because there is no standard of care established for a structured exercise program for patients on ECMO. These patients are primarily bed bound for the majority of their illness in the early stages; if early implementation of a structured exercise regimen is started then the amount of time it takes patients to return to their physical physiological baseline will be decreased, thus improving their quality of life.

A thorough review of the literature indicates that there is a critical lack of studies of rehabilitation, movement, or physical activity in the ECMO patient population. Furthermore, a structured rehabilitation program for ECMO patients simply does not exist. The use of a structured resistant exercise program in this population has not been studied. Thus, overcoming this deficiency is extremely important for the 10% of intensive care unit (ICU) admissions with cardiac and respiratory failure across the nation, specifically those who are placed on ECMO.

Approximately 30 studies exist in the literature that describe rehabilitation in the ECMO patient population. Briefly, these studies in adults with severe lung dysfunction have shown that participation in rehabilitation programs incorporating mobility training and physical (PT) and occupational therapy (OT) significantly improve functional and physiological outcomes and decrease muscle wasting, sedation requirements, and length of stay. The patients that participate in rehabilitation also increase endurance and have full stabilization of the cardiopulmonary system and full recovery of neurological functions. Most importantly, it has been shown that patients with severe lung dysfunction who enter a rehabilitation program decrease mortality, and they are more likely to be discharged home.

III. Rationale There is a need for randomized controlled trials to study methods for rehabilitation in the ECMO population, and this proposal serves as the first step towards that goal. The investigators firmly believe that the activities proposed here will beneficially impact the ECMO patient population by improving physiological responses, physical function, and psychosocial well-being. In bed-ridden and immobile adults, exercise and movement are important in reducing risk factors such as obesity, insulin resistance, and general deconditioning. The evidence base for this program can be found in both the basic and clinical science literature of several patient populations: adult and pediatric burns, geriatric and frail, bed rest and antigravity (via National Aeronautics and Space Administration \[NASA\] studies), post-cardiac arrest, and traumatic brain injury (TBI). Hence, the investigators have formed a team of thought leaders from these areas to create a personalized rehabilitation program in the ECMO population.

This study will advance our knowledge in how a structured exercise program effects ECMO patients in their short- and long-term outcomes. There will be an advancement of knowledge in the physiological benefits of exercising ECMO patients. The verticalization into daily nursing care, mobility exercises, PT/OT, and resistance training will give the investigators a better understanding of the components that help keep muscle wasting minimal and help decrease a patient's length of stay.

Decreased muscle wasting and length of stay, decreased risk of mortality, and decreased sedation requirements will increase the likelihood that patients will have a full cardiopulmonary and neurological recovery. Longer treatment periods also translate into significant costs in dollars but, also in human cost/value.

SECTION B: RESEARCH PLAN

IV. Study Objectives The objectives of this study are to complete the highest intensity exercise and activity as tolerated by patients to maximize their progression of strength, function, and out of bed activity. In doing this, the investigators will also reduce the risk for potential of skin breakdown on common areas associated with decubitus pressure injuries and prolonged bedrest. In this study, the investigators will be utilizing 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 ADLs.

Study Timeline

• Study Start: 2024-10-25
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Timing of exercises	From enrollment to 3-month follow-up	Time spent exercising per each session of rehabilitation program

Secondary Outcome Measures

Name	Time	Method
Mobility	From enrollment to 3-month follow-up	Time spent standing away from bed (minutes)
Function	From enrollment to 3-month follow-up	Functional Independence Measure (FIM) from Activities of Daily Living (ADL). Each ADL will be graded per the FIM Instrument using the disability measure definitions from Total Assistance to Complete Independence.
Resistance Training	From enrollment to 3-month follow-up	Repetitions will be counted and documented per session per exercise. Grip strength will be tested using a hand dynamometer. The subject will be seated with their elbows at his/her side and flexed at right angles, and their wrists will be at a neutral position. The grip strength of the dominant hand will be tested as the average of three trials

Trial Locations

Locations (1)

Methodist Healthcare System; 🇺🇸 San Antonio, Texas, United States