Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Other: Early Rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia
      • Royal Prince Alfred Hospital
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
    • Woolloongabba, Queensland, Australia
      • Princess Alexandra Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health
  • Western Australia
    • Murdoch, Western Australia, Australia
      • Fiona Stanley Hospital
• Canada
  • Toronto, Canada
    • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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.

What is the study measuring?

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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Number of patients who suffered adverse events and serious adverse events such as fall, heart attack or new or increased oozing around cannulae during rehabilitation.	Up to 28 days post randomisation

Collaborators and Investigators

• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborators: National Health and Medical Research Council, Australia; Monash University
• Investigators: Principal Investigator: Carol Hodgson, ANZIC-RC, Monash University

Publications and helpful links

General Publications

• ECMO-PT Study Investigators; International ECMO Network. Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trial. Intensive Care Med. 2020 May;46(5):1057-1059. doi: 10.1007/s00134-020-05994-8. Epub 2020 Mar 16. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; ECMO
• Other Study ID Numbers: ANZIC-RC/ECMO-REHAB/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No