Suspended

ECMO-RehabA Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)

What is being tested

Early Rehabilitation

Other

Who is being recruted

Over 18 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: April 2022

See protocol details

Summary

Principal SponsorAustralian and New Zealand Intensive Care Research Centre

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 27, 2022

Actual date on which the first participant was enrolled.

The trial is a 100-patient, multicentre, randomised, controlled, parallel-group, two-sided superiority trial that will randomly allocate eligible patients to early rehabilitation or standard care in a 1:1 ratio to determine if early rehabilitation of critically ill patients receiving ECMO reduces disability when compared with standard care. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.

Official TitleA Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)

NCT05003609

Principal SponsorAustralian and New Zealand Intensive Care Research Centre

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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

Patient is aged 18 years or older.

Patient was functionally independent prior to the current admission.

Patient is eligible for Medicare (Australian sites only).

11 exclusion criteria prevent from participating

Patient has been receiving ECMO for more than 72 hours.

Patient has been in ICU for more than 5 days.

Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury.

Death is deemed imminent by the treating clinician.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Royal Prince Alfred Hospital

Camperdown, AustraliaOpen Royal Prince Alfred Hospital in Google Maps

Suspended

St Vincent's Hospital Sydney

Darlinghurst, Australia

Suspended

The Prince Charles Hospital

Chermside, Australia

Suspended

Princess Alexandra Hospital

Woolloongabba, Australia

Suspended7 Study Centers