Early Rehabilitation for Patients on ECMO

(ECMO-Rehab Trial)

Not currently recruiting at 6 trial locations

Overseen By Nicole Ng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Australian and New Zealand Intensive Care Research Centre

Disqualifiers: Cognitive impairment, Pregnancy, Myopathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting rehabilitation early can aid recovery for people on ECMO, a life-support machine that assists with breathing and heart function. The main goal is to determine if early rehab improves muscle strength and overall function compared to standard care. Eligible participants are those currently on ECMO, expected to remain on it for at least a day, and who were independent before their hospital stay. The study will also assess the treatment's impact on survival, health, and costs after six months. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance recovery for future ECMO patients.

Do I have to stop taking my current medications for the ECMO rehabilitation 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 team or your doctor.

What prior data suggests that early rehabilitation for ECMO patients is safe?

Research has shown that starting rehabilitation early for patients on ECMO (a machine that helps people breathe when their lungs can't) is safe and feasible. Studies have found that physical therapy during ECMO can improve breathing and prevent muscle loss. In one study, early exercises for patients on ECMO proved safe and manageable. Another study suggested these exercises might address muscle issues and enhance quality of life. Overall, the treatment appears well-tolerated and beneficial, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early rehabilitation for patients on ECMO because it offers a proactive approach to recovery while patients are still in intensive care. Unlike standard care, which typically involves general nursing and physiotherapy, this method is led by a senior physiotherapist with specialized ECMO training. The treatment emphasizes individualized physical activity, functional retraining, and strengthening exercises from the start, aiming to improve patient outcomes and potentially shorten hospital stays. By coordinating care from randomization through to discharge, this approach hopes to enhance recovery and quality of life for ECMO patients.

What evidence suggests that early rehabilitation is effective for improving muscle strength and functional status in ECMO patients?

Research has shown that starting rehabilitation early for patients on ECMO (a machine that helps the heart and lungs work) can improve muscle strength and prevent muscle loss. In this trial, participants in the intervention group will receive early rehabilitation led by a senior physiotherapist, including physical activity, functional retraining, strengthening exercises, and mobilisation. Studies have found that this early rehabilitation can also enhance the quality of life for these patients. By beginning physical exercises and training soon, patients may recover their physical abilities more effectively. Initial findings suggest that these activities help patients become stronger and regain function faster. This approach emphasizes getting patients moving and active shortly after they begin ECMO support. ^{2 3 5 6 7}

Who Is on the Research Team?

Carol Hodgson

Principal Investigator

ANZIC-RC, Monash University

Are You a Good Fit for This Trial?

This trial is for critically ill adults on ECMO who are expected to need it for at least another day and were independent in daily activities before their current hospital stay. It's open to Medicare-eligible patients in Australia.

Inclusion Criteria

I was able to take care of myself before being admitted this time.

Patient is on ECMO and expected to remain on ECMO for at least 24 hours

Patient is eligible for Medicare (Australian sites only).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Early rehabilitation commenced within 72 hours of ECMO, involving physical activity, functional retraining, strengthening exercises, and mobilisation

28 days

Daily visits in ICU

Follow-up

Participants are monitored for safety, effectiveness, and functional recovery after treatment

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Early Rehabilitation

Trial Overview The study tests if starting rehabilitation within 72 hours of beginning ECMO helps improve muscle strength and overall function compared to standard care. The trial will track survival, health status, function after six months, and cost-effectiveness using data from the EXCEL registry.

How Is the Trial Designed?

Group I: Intervention Group Active Control 1 Intervention

ECMO early rehabilitation is led by a senior physiotherapist who has specialised training in ECMO care and coordinates individualised early physical training from randomisation to day 28 in ICU and liaises with the patient through to hospital discharge. The early rehabilitation intervention involves physical activity, functional retraining, strengthening exercises and mobilisation based on a reproducible, physiological approach.

Group II: Control Group Active Control 1 Intervention

The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation.

Who Is Running the Clinical Trial?

Australian and New Zealand Intensive Care Research Centre

Lead Sponsor

Trials

49

Recruited

80,600+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+

National Health and Medical Research Council, Australia

Collaborator

Trials

167

Recruited

473,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10204448/

The Early Mobilization of Patients on Extracorporeal ... The results indicated that the mean duration of support time on ECMO was 393 h for the intervention group which was slightly longer than the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0964339724001290

Effect of an evidence-based early rehabilitation program on ... This program can improve skeletal muscle atrophy and dysfunction in patients with VV-ECMO effectively and perhaps improve quality of life for patients in the ...

3. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202102-151OC

Annals of the American Thoracic Society Conclusions: Several patient- and ECMO-related factors were associated with achieving higher intensity of early mobilization in patients ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05003609

Early Rehabilitation in Patients on Extracorporeal ... This registry-embedded randomised trial aims to determine if early rehabilitation commenced within 72 hours of ECMO is feasible and improves muscle strength and ...

5. journals.lww.com journals.lww.com/ccejournal/fulltext/2025/09000/jump_on_it__the_association_of_physical_therapy.15.aspx

Jump On It! The Association of Physical Therapy Timing ... Patients who did not participate in PT were more likely to be supported with venoarterial ECMO (62%, n = 29/47 vs. 37%, n = 35/95; p = 0.01) and had a higher ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6649220/

Safety and potential benefits of physical therapy in adult ... Physical therapy with ECMO is feasible and relatively safe, with potential benefits including improved respiratory function and reduced muscle mass loss.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.062949

Results of the ECMO-CS Randomized Clinical Trial Resuscitated cardiac arrest occurred in 10.3% of the immediate VA-ECMO group and 13.6% of the early conservative group (HR, 0.790 [95% CI, 0.274–2.277]) (Table ...