Active not recruitingNAINTERVENTIONAL

Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

This study, called the ECMO-Rehab trial, is for patients who are extremely unwell and need a life support machine called ECMO. While more patients are now surviving with ECMO, many find it hard to get back to their normal lives afterwards. This research wants to see if starting physical rehabilitation within 72 hours (three days) of being on ECMO can significantly improve muscle strength and overall recovery. They will compare early rehabilitation with the usual care. The study aims to find out if this approach helps patients get better faster and live a healthier life even six months later, as well as if it's a good use of healthcare resources. It will involve 100 patients in intensive care.

At a glance

Status

Active not recruiting

Phase

Sponsor

Australian and New Zealand Intensive Care Research Centre

Enrolment target

100

Start

27 Apr 2022

Estimated completion

30 May 2025

Extracorporeal Membrane Oxygenation Complication

What is this study about?

When people are critically ill and their heart or lungs stop working properly, a special machine called ECMO (Extracorporeal Membrane Oxygenation) can take over. This machine acts like an artificial lung or heart, giving the body time to heal. It's a life-saving treatment, and thankfully, more patients are surviving because of it. However, after leaving the hospital, many ECMO survivors experience lasting problems like muscle weakness and difficulty with daily activities, which can affect them for months or even years.

This study, called the ECMO-Rehab trial, wants to find a way to help patients recover better. It focuses on 'early rehabilitation,' which means starting gentle physical exercises and movements very soon after a patient goes on ECMO – specifically, within three days. The main goal is to see if this early start makes a real difference in how quickly and how well patients regain their muscle strength and their ability to do everyday things. They will compare patients who get this early rehabilitation with those who receive the usual care.

The researchers will follow up with patients for six months to see how they are doing. They will check things like how well they can move around, their general health, and whether they are alive. The study will also look at the costs involved, to see if early rehabilitation is a good and effective way to help patients. By studying 100 patients in intensive care, they hope to find clear answers that could improve care for many future patients.

Key takeaways

This study aims to discover if early exercise helps very sick ECMO patients recover better.
It compares early rehabilitation to standard care.
The study will check muscle strength and recovery at hospital discharge and after six months.
It includes 100 patients and hopes to improve future patient care.
Participation is randomly assigned to one of two care groups.
You can stop participating at any time without affecting your treatment.

Who may be eligible?

For you to be considered for this study, you must be at least 18 years old and currently on the ECMO machine. Before your current hospital stay, you also need to have been able to get around and do daily activities on your own without much help.

There are several reasons why you might not be able to join the study. For example, if you've been on ECMO for more than three days already, or if you've been in intensive care for over five days, you wouldn't be eligible. Also, if there are concerns that you have a serious brain injury, a muscle or nerve condition that causes long-term weakness, or if doctors think your condition is too severe and you might not live much longer, you wouldn't be able to participate.

Other reasons for not being able to join include having memory problems like dementia, not being able to walk before this hospital stay, or not being able to communicate in the local language. Women who are pregnant, people who are unlikely to be reachable for follow-up in six months (like those living overseas), or if your doctor believes it's not in your best interest to join, would also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently on an ECMO machine?
Were you able to move around and live independently before this current illness?
Have you been on ECMO for less than 3 days?
Have you been in the intensive care unit for less than 5 days?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive early rehabilitation or the usual care, decided by chance, like flipping a coin. Both groups will be closely monitored by your medical team.

If you are in the early rehabilitation group, you will start gentle physical activities and exercises with therapists within three days of being on ECMO. This will continue as appropriate for your condition. If you are in the usual care group, you will receive rehabilitation according to the hospital's standard procedures.

Throughout your hospital stay, your muscle strength and ability to move will be regularly checked. After you leave the hospital, the study team will contact you at 180 days (about six months) to see how you are recovering, how well you can do daily tasks, and how your overall health is. The total duration of active follow-up for the study is six months.

Potential risks and benefits

Participating in research always carries some unknowns. The potential benefits of this study include the possibility that early rehabilitation could help you regain strength and function more quickly compared to standard care, potentially leading to a better recovery and quality of life. The risks are generally low, as rehabilitation will be tailored to your condition and closely supervised by medical professionals. However, as with any medical intervention, there's always a small chance of unexpected events. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Royal Prince Alfred Hospital
Verified postcode
Camperdown, Australia
St Vincent's Hospital Sydney
Verified postcode
Darlinghurst, Australia
The Prince Charles Hospital
Verified postcode
Chermside, Australia
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia
Alfred Health
Verified postcode
Melbourne, Australia
Fiona Stanley Hospital
Verified postcode
Murdoch, Australia
Toronto General Hospital
Verified postcode
Toronto, Canada

Common questions

What is ECMO?

ECMO is a life support machine that takes over the job of your heart or lungs when they are too sick to work properly, giving your body time to heal.

What does 'early rehabilitation' mean?

It means starting gentle physical activities and exercises with therapists very soon, within three days, of starting ECMO treatment.

Will I definitely get early rehabilitation if I join?

No, you will be randomly assigned to either receive early rehabilitation or the usual hospital care, like drawing lots.

How long will the study follow me?

The study team will check in with you about your recovery approximately six months after you join.

Can I leave the study if I change my mind?

Yes, you can choose to stop being part of the study at any time, and this will not affect your medical care.