Extracorporeal Membrane Oxygenation Physical Training

NCT ID: NCT03328767

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-19
• Study Completion Date: 2020-05-01

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 trial aims to determine if early, physical training commenced within 48 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 30 ICU patients.

Detailed Description

The use of extracorporeal membrane oxygenation (ECMO) has expanded dramatically in Australia and globally. While life-saving in the short-term, it is typically associated with prolonged immobility and inflammation, which contributes to severe muscle weakness and wasting. Standard care delivers minimal physical training while patients remain on ECMO because standard care prioritises concerns about catheter dislodgement and cardio-respiratory strain. However, in other intensive care unit (ICU) conditions, techniques have been developed to allow early physical training in patients previously thought too unstable to be exercised, with important patient-centred and long-term cost-saving benefits. Our preliminary work shows that early individualised physical training is safe in ICU patients. A multicentre pilot study to establish feasibility in ECMO patients is urgently needed.

The primary aim is to test the hypothesis that early, individualised, physical training (commenced within first 48 hours of ECMO) is feasible and improves functional recovery (the highest level of activity and duration). This has previously been reported to be associated with improved independent function at hospital discharge and discharge to home.1 The secondary aims are to test the hypothesis that early individualised physical training is (i) safe; (ii) improves muscle strength at day 7 and 10 and 20; and (iii) improves functional status (IMS) at day 7, 10 and 20 in ECMO patients relative to standard care.

We are also aiming to describe the acute physiological effects of early physical training (commenced within 48hours of ECMO initiation) Respiratory and haemodynamic parameters, along with ECMO settings, will be recorded 30 minutes prior to each physical training session, during the session and 30 minutes post the training session. In addition, the range of values (min to max) for these parameters will be recorded for each 24hour period over the 7 days.

Conditions

Critically Ill, Mechanically Ventilated; Extracorporeal Membrane Oxygenation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early activity and Mobilisation intervention

Patients will be randomised within 48 hrs of commencing ECMO. Patients unable to initially receive active physical training will receive passive physical training for a minimum of 20 minutes and a maximum of one hour per day to maintain joint and muscle activity until active physical training is commenced. The intervention involves a progression of 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 minutes) at each session, based on our published ICU mobility scale now used internationally in ICU trials. This is performed with or without IMV (including both endotracheal tubes or tracheostomies).

Group Type: EXPERIMENTAL

Early activity and Mobilisation intervention

Intervention Type: BEHAVIORAL

The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Standard Care

The control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early activity and Mobilisation intervention

The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• adults ≥ 18 years of age
• were physically independent prior to the current admission;
• receiving ECMO (veno-arterial or veno-venous) for at least 24 hours;
• clinician in charge of patient care has no objection to randomisation

Exclusion Criteria

• have been in ICU > 5 days prior to the commencement of ECMO;
• have received ECMO for more than 48 hours;
• in the opinion of the treating clinician, is not expected to recover in 90 days (e.g. intracerebral haemorrhage);
• whom death is expected within 24 hours;
• are unable to communicate in English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toronto General Hospital

OTHER

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: collaborator

The Alfred

OTHER

Sponsor Role: collaborator

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role: collaborator

The Prince Charles Hospital

OTHER_GOV

Sponsor Role: collaborator

St Vincent's Hospital, Sydney

OTHER

Sponsor Role: collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

St Vincent's Hospital

Sydney, New South Wales, Australia

The Prince Charles Hospital

Chermside West, Queensland, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Australia; Canada

References

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Reference Type: BACKGROUND

PMID: 19446324 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 23159157 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 27015233 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7129724 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22879441 (View on PubMed)

Hodgson CL, Stiller K, Needham DM, Tipping CJ, Harrold M, Baldwin CE, Bradley S, Berney S, Caruana LR, Elliott D, Green M, Haines K, Higgins AM, Kaukonen KM, Leditschke IA, Nickels MR, Paratz J, Patman S, Skinner EH, Young PJ, Zanni JM, Denehy L, Webb SA. Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults. Crit Care. 2014 Dec 4;18(6):658. doi: 10.1186/s13054-014-0658-y.

Reference Type: BACKGROUND

PMID: 25475522 (View on PubMed)

Puthucheary ZA, Denehy L. Exercise Interventions in Critical Illness Survivors: Understanding Inclusion and Stratification Criteria. Am J Respir Crit Care Med. 2015 Jun 15;191(12):1464-7. doi: 10.1164/rccm.201410-1907LE. No abstract available.

Reference Type: BACKGROUND

PMID: 26075426 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32179935 (View on PubMed)

Related Links

https://doi.org/10.1007/s00134-020-05994-8

Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trial

Other Identifiers

ANZICRC/ECMO/001

Identifier Type: -

Identifier Source: org_study_id