Early Rehabilitation for Patients on ECMO

(ECMO-Rehab Trial)

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the sickest in the hospital. More patients are surviving but survivors have compromised functional recovery for months or years. This registry-embedded randomised trial aims to determine if early rehabilitation commenced within 72 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 100 ICU patients. The effect of the intervention on mortality, health status, and function at 180 days will be evaluated, as well as cost-effectiveness. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.

Research Team

Carol Hodgson

Principal Investigator

ANZIC-RC, Monash University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+