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Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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).

Exclusion criteria

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.

Patient has a documented medical diagnosis of cognitive impairment e.g. dementia.

Patient was unable to mobilise prior to this admission.

Patient is unable to communicate in local language.

Patient is known to be pregnant.

Patient is unlikely to be contactable for 6 months follow-up, e.g. overseas resident, incarcerated

The treating clinician does not believe it is in the best interests of the patient to participate in the study

Patient who has a bidirectional cannula in situ

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-04-27

Primary completion: 2025-05-30

Study completion finish: 2025-05-30

Study type

TREATMENT

Phase

Trial ID

NCT05003609

Intervention or treatment

OTHER: Early Rehabilitation

Conditions

• Extracorporeal Membrane Oxygenation Complication

Image related to Extracorporeal Membrane Oxygenation Complication

Condition: Extracorporeal Membrane Oxygenation Complication
OTHER: Early Rehabilitation
Darlinghurst, New South Wales, Australia and more
Sponsor: Australian and New Zealand Intensive Care Research Centre

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

St Vincent's Hospital Sydney

Research sites nearby

Select from list below to view details:

St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia

Study Plan

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

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Intervention Group 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.	OTHER: 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.
NO_INTERVENTION: Control Group The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation.	Not specified

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Intervention Group

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.

OTHER: 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.

NO_INTERVENTION: Control Group

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

Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Modified Rankin Scale	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).	180 days post randomisation

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Muscle strength at day 14 (Medical Research Council Sum-Score)	Grade 0 to Grade 5 where Grade 5 is the best outcome	14 days post randomisation
ECMO-free days to day 28	Not Specified	28 days post randomisation
Organ failure free days to day 28	Not Specified	28 days post randomisation
Delirium-free days to day 28	Not Specified	28 days post randomisation
Activities of Daily Living (ADL) at hospital discharge	Not Specified	up to day of hospital discharge, an average of 3 months
Length of stay on ECMO, in ICU and in hospital	Not Specified	up to day of stay on ECMO, ICU and hospital, an average of 3 months
Mortality rate at ICU and hospital discharge, day 90 and day 180	Not Specified	up to 180 days post randomisation
Instrumental activities of daily living at 180 days	Physical function measured with instrumental activities of daily living	180 days post randomisation
Montreal Cognitive Assessment (MoCA-Blind)	Rapid screening instrument for mild cognitive dysfunction. Normal is equal or more than 18 points.	180 days post randomisation
WHO Disability Assessment Schedule 2.0 at day 180	Scoring 10-48 are likely to have clinically significant disability.	180 days post randomisation
Health related quality of life (EQ5D-5L) at day 180	Level of severity 1 to 5 where 5 is the most severe	180 days post randomisation
Daily longitudinal ordinal organ support outcome to day 28	This includes outcomes on Dead; on ECMO; Off ECMO on IMV; Off IMV, in ICU; On acute hospital ward; Discharged alive	28 days post randomisation
Healthcare costs at day 180	Index hospital admission costs will be determined using clinical costing systems at each participating site. Post discharge costs will be determined using patient-level data linkage to determine long-term health care use (including readmission to hospital).	180 days post randomisation
Cost-effectiveness at day 180	The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 180 days.	180 days post randomisation

Frequently Asked Questions

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References

Clinical Trials Gov: Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation