Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation
NCT ID: NCT05003609
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2022-04-27
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Control Group
The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Monash University
OTHER
National Health and Medical Research Council, Australia
OTHER
Australian and New Zealand Intensive Care Research Centre
OTHER
Responsible Party
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Principal Investigators
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Carol Hodgson
Role: PRINCIPAL_INVESTIGATOR
ANZIC-RC, Monash University
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
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
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Toronto General Hospital
Toronto, , Canada
Countries
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References
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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.
Other Identifiers
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ANZIC-RC/ECMO-REHAB/001
Identifier Type: -
Identifier Source: org_study_id