Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

NCT05003609 | Active Not Recruiting DMC

• 1 other identifier: ANZIC-RC/ECMO-REHAB/001
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

Rehabilitation; ECMO

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Muscle strength at day 14 (Medical Research Council Sum-Score)

  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

Other Outcomes (1)

• Incidence of adverse events

  Up to 28 days post randomisation

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

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

Interventions

Early Rehabilitation OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Monash University: collaborator
• National Health and Medical Research Council, Australia: collaborator

Study Sites (7)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Location

Toronto General Hospital

Toronto, Canada

Location

Related Publications (1)

• 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.

  PMID: 32179935 BACKGROUND

Study Officials

• Carol Hodgson

  ANZIC-RC, Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded outcome assessor - blinded / different therapist (strength) and central follow-up for blinded assessment of PROMs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1;1 allocation, stratified by site,

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 12, 2021
• Study Start: April 27, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); CA (1)