RecruitingNAINTERVENTIONAL

Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )

This study, called IMEMPRO, is investigating a new approach to reduce muscle weakness in patients in intensive care. Many patients in ICU develop weakness, which can make their recovery harder and have long-lasting effects. Researchers want to see if giving patients extra protein through a feeding tube, combined with gentle exercise and electrical stimulation to their muscles, can help. They will compare 20 patients receiving this new approach with 20 patients getting standard care. The main goal is to see if the new method significantly reduces the loss of muscle, and also if it improves muscle strength and energy levels, helping patients get better sooner and have a better quality of life after leaving hospital.

At a glance

Status

Recruiting

Phase

Sponsor

Technical University of Munich

Enrolment target

Start

27 Jun 2023

Estimated completion

31 Jan 2027

ICU Acquired Weakness Muscle Atrophy Energy Malnutrition Protein Quality of Life Morphological and Microscopic Findings Metabolic Disturbance

What is this study about?

When people are very poorly and in intensive care (ICU), a common problem they can develop is something called "ICU Acquired Weakness." This means their muscles become very weak, and it can happen to about 40 out of every 100 patients. This weakness can make it much harder for them to recover, both in the short term while in hospital and in the long term, potentially affecting their health for up to five years after leaving the ICU. We know that when you're in ICU, your muscles can waste away very quickly, even in just a few days.

Doctors are always looking for better ways to help patients avoid this muscle weakness. We already know that getting patients moving early and using electrical stimulation to gently activate their muscles can help. We also know that what you eat, especially how much protein you get, is really important for muscle health. This study wants to find out if combining both these approaches – giving extra protein through a feeding tube and early muscle activation (like gentle exercise and electrical stimulation) – is even more effective at preventing muscle loss.

In this study, 40 patients who have recently been admitted to the ICU will take part. Half of them (20 patients) will receive the newer approach, which involves getting a higher amount of protein in their nutrition and having their muscles activated twice a day using a gentle electrical current, alongside moving them as much as safely possible. The other half (20 patients) will receive the usual care that patients in intensive care receive. By comparing these two groups, the researchers hope to understand if the combined approach can significantly reduce the amount of muscle lost. They will also look to see if it helps with muscle strength and how well patients can move around, ultimately aiming for a better recovery and quality of life.

Key takeaways

ICU Acquired Weakness affects many critically ill patients.
This study combines higher protein intake with early muscle movement and electrical stimulation.
The aim is to reduce muscle loss and improve recovery after intensive care.
One group receives this new combined approach, while the other receives usual care.
Researchers will check muscle health using scans and, with consent, muscle samples.
The study hopes to find better ways to help patients regain strength and quality of life.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) who has recently been admitted to the intensive care unit (within the last two days). You also need to be on a breathing machine, which is expected to be needed for at least three days, and be able to receive nutrition through a feeding tube.

There are some reasons why you wouldn't be able to join the study. For example, if you are very overweight (a BMI over 30), if doctors believe you might not survive your illness or that your life support might be stopped soon, or if you already had muscle or nerve problems before your current illness. Also, if there's an injury or condition that would make it unsafe to do muscle exercises or electrical stimulation, like certain head injuries or an unstable spine, you couldn't join. Having a pacemaker, an allergy to the sticky pads used for electrical stimulation, or needing help with daily tasks before you got sick would also mean you couldn't take part. Lastly, if there's a language barrier that prevents clear communication, you wouldn't be able to join.

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?
Have you been in intensive care for less than two days?
Do you need a breathing machine for at least three more days?
Can you receive nutrition through a feeding tube?
Do you have a pacemaker or other electronic implant?
Did you need help with daily tasks before getting sick?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would be assigned to one of two groups. One group would receive standard intensive care treatment. The other group would receive an enhanced treatment plan. This enhanced plan involves getting more protein in your usual tube feeding and having staff help you move your muscles as much as is safely possible each day. Additionally, your muscles would be gently stimulated with small electrical currents twice a day. The study will monitor your muscle health using ultrasound scans of your thigh muscle. If you give separate permission, a very small sample of muscle (a biopsy) might also be taken to look at it more closely. The study doesn't specify a total duration, but treatments and assessments would continue for as long as you are able to participate while in intensive care. There are no additional visits required once you leave the ICU.

Potential risks and benefits

Participating in this study might offer a potential benefit of better muscle preservation and recovery compared to standard care, which could lead to a better quality of life after leaving the intensive care unit. However, there is no guarantee that you will personally benefit. Potential risks include discomfort from the electrical muscle stimulation or the muscle biopsy, though these procedures are generally safe and performed by trained staff. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich
Verified postcode
Munich, Germany· Active not recruiting
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Active not recruiting
Universitätsklinikum Ulm
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is ICU Acquired Weakness?

It's a common problem where muscles become weak in patients who are very ill and in intensive care, making recovery harder.

What is 'muscle activation' in this study?

It means gently exercising muscles and using small electrical currents to stimulate them, helping to keep them active.

Why is protein important?

Protein is a building block for muscles. Getting enough can help prevent muscle loss, especially when you're ill.

Will I get special food?

You'll receive your usual nutrition through a feeding tube, but for one group, the amount of protein in that nutrition will be increased.

How will they check my muscles?

They will use ultrasound scans on your thigh muscle, and with your consent, a tiny muscle sample might also be taken.

How to find out more

Stefan J Schaller, MD

s.schaller@tum.de +498941409635 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.