Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

NCT05003609 · tracked via the Priya Life Science Australia tracker

Sponsor

Australian and New Zealand Intensive Care Research Centre

Phase

Not applicable

Started

2022-04-27

Last updated

2024-12-10

Condition(s) studied

Extracorporeal Membrane Oxygenation Complication

Investigational drug(s) / intervention(s)

Early Rehabilitation

Early Rehabilitation: The intervention involves a progression of rehabilitation exercises with the objective of rehabilitating the patient at the highest level of exercise possible for the patient for the longest period of time that can be tolerated (up to 60 mins) at each session. The intervention will be administered 5 days per week (weekdays) while the patient remains in ICU, censored at 28 days after randomisation.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patient is on ECMO and expected to remain on ECMO for at least 24 hours 2. Patient is aged 18 years or older. 3. Patient was functionally independent prior to the current admission. 4. Patient is eligible for Medicare (Australian sites only). Exclusion Criteria: 1. Patient has been receiving ECMO for more than 72 hours. 2. Patient has been in ICU for more than 5 days. 3. Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury. 4. Death is deemed imminent by the treating clinician. 5. Patient has a documented medical diagnosis of cognitive impairment e.g. dementia. 6. Patient was unable to mobilise prior to this admission. 7. Patient is unable to communicate in local language. 8. Patient is known to be pregnant. 9. Patient is unlikely to be contactable for 6 months follow-up, e.g. overseas resident, incarcerated 10. The treating clinician does not believe it is in the best interests of the patient to participate in the study 11. Patient who has a bidirectional cannula in situ

Primary outcome measure(s)

Modified Rankin Scale — 180 days post randomisation
The Modified Rankin Scale (mRS) is a 7-level ordered categorical scale capturing levels of patient disability and dependence, with scores ranging from 0 (no disability) to 6 (dead).

Trial sites (7)

Facility	City	Region
Royal Prince Alfred Hospital	Camperdown	New South Wales
St Vincent's Hospital Sydney	Darlinghurst	New South Wales
The Prince Charles Hospital	Chermside	Queensland
Princess Alexandra Hospital	Woolloongabba	Queensland
Alfred Health	Melbourne	Victoria
Fiona Stanley Hospital	Murdoch	Western Australia
Toronto General Hospital	Toronto	Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05003609 on ClinicalTrials.gov ↗ ← All trials in Australia