Early Rehabilitation for Patients on ECMO
(ECMO-Rehab Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byCarol Hodgson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Australian and New Zealand Intensive Care Research Centre

No Placebo Group

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.

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

I am 18 years old or older.

+1 more

Participant Groups

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.

2Treatment groups

Active Control

Group I: Intervention GroupActive Control1 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 GroupActive Control1 Intervention

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