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

N/A

Recruiting

Led By Carol Hodgson

Research Sponsored by Australian and New Zealand Intensive Care Research Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is aged 18 years or older.

Patient was functionally independent prior to the current admission.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days post randomisation

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if starting rehabilitation within 72 hours of a certain type of life support called ECMO can help critically ill patients recover better. The study will involve 100 ICU patients and will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves early rehabilitation rather than a drug or medical device, side effects may include typical risks associated with physical therapy such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days post randomisation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days post randomisation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days post randomisation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Rankin Scale

Secondary study objectives

Cost-effectiveness at day 180

Daily longitudinal ordinal organ support outcome to day 28

Health related quality of life (EQ5D-5L) at day 180

+5 more

Other study objectives

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met