Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Title
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A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)

Conditions
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Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
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* Other: Early Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1;1 allocation, stratified by site,
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | 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 |  | 28 days post randomisation | 
| Organ failure free days to day 28 |  | 28 days post randomisation | 
| Delirium-free days to day 28 |  | 28 days post randomisation | 
| Activities of Daily Living (ADL) at hospital discharge |  | up to day of hospital discharge, an average of 3 months | 
| Length of stay on ECMO, in ICU and in hospital |  | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, ECMO