RecruitingNAINTERVENTIONAL

Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU

This study, called NUTRIREA-4, is investigating if an early and ongoing rehabilitation plan can improve long-term recovery for patients who have been very unwell and needed a breathing machine (ventilator) and strong medications in intensive care (ICU). This special plan includes personalised nutrition, physiotherapy, and physical activities. It starts while the patient is still in the ICU and continues after they leave the hospital, even at home. The study compares this new approach to the standard care patients usually receive. The aim is to see if this combined, tailored support helps people get back to feeling better and living their lives more fully after such a serious illness.

At a glance

Status

Recruiting

Phase

Sponsor

Nantes University Hospital

Enrolment target

830

Start

14 Dec 2024

Estimated completion

14 Dec 2027

Mechanical Ventilation

What is this study about?

When someone is very ill and needs a breathing machine (called a ventilator) in intensive care (ICU), their body goes through a lot. They can become very weak, and it can take a long time to get back to normal after leaving the hospital. This study is looking into whether a special programme can help these patients recover better in the long run.

The programme being tested is a combination of things: personalised nutrition, physiotherapy (exercises to regain strength and movement), and other physical activities. The key is that this support starts very early, while the patient is still in ICU, and then continues without interruption when they move out of ICU and even after they go home. Researchers want to see if this continuous, tailored approach helps people achieve better health and a stronger recovery compared to the usual care they would receive.

Patients taking part in the study will either receive this new, extended rehabilitation programme or the standard care that hospitals usually provide. Standard care also includes nutrition and physiotherapy, but the special programme is more structured, personalised, and goes on for longer. By comparing these two groups, the study hopes to find the best way to help people recover more fully after a very serious illness.

Key takeaways

The study aims to improve recovery for seriously ill patients needing breathing support.
It tests a special programme of nutrition and activity, starting early and continuing at home.
Compares this new approach to standard hospital care.
Focuses on long-term health improvements after leaving the ICU.
Participation involves close monitoring of health and recovery.

Who may be eligible?

This study is looking for adults aged 18 or older who have recently been put on a breathing machine (ventilator) in intensive care and are also receiving strong medication to support their blood pressure. They should also be expected to need the ventilator for at least another two days and likely need nutritional support soon after.

There are several reasons someone might not be able to join the study. For example, if they have already been on a ventilator for more than 24 hours, have certain long-term health conditions that affect nutrition or strength (like a spinal injury, severe brain injury, or inability to walk before their illness), or currently have a short life expectancy. People who are pregnant, breastfeeding, or have severe hearing or vision problems that would make phone or video calls difficult also wouldn't be able to take part.

The study also has some rules about social circumstances, such as needing a stable address and phone number for follow-up, and specific legal requirements for participating in a study in France.

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 recently started needing a breathing machine in intensive care and strong blood pressure medication?
Do you expect to need the breathing machine for at least two more days?
Are you generally able to communicate by phone or video calls (no severe hearing/visual issues)?
Did you generally walk before your current illness and do not have certain serious pre-existing health conditions (like severe brain injury or chronic neuromuscular disease)?
Do you have a stable address and phone number for follow-up?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part in this study, you will either receive the special early and extended rehabilitation programme or the standard care. The special programme involves personalised nutrition plans, physiotherapy sessions, and physical activities designed specifically for you, starting when you are in the ICU and continuing after you are discharged from the hospital, including support at home. Both groups will have their progress followed closely. This will involve regular assessments of your health, strength, and overall recovery, likely through hospital visits, phone calls, or video consultations. The exact duration of your participation will depend on your recovery, but the aim is to track long-term outcomes to see the full benefits of the programme.

Potential risks and benefits

Taking part in this study could potentially help you recover strength and improve your overall well-being after a severe illness, especially if you receive the extended rehabilitation programme. However, like any medical study, there's always a possibility that the new approach might not be more effective than usual care, or could have unforeseen aspects, although the interventions (nutrition and physical activity) are generally considered safe. You will be closely monitored throughout your participation. Remember, agreeing to join the study is entirely your choice, and you are free to withdraw at any time without affecting your medical care.

Locations (52)

CH d'Albi
Verified postcode
Albi, France· Recruiting
CHU d'Amiens - Site Sud
Verified postcode
Amiens, France· Recruiting
CHU d'Amiens
Verified postcode
Amiens, France· Recruiting
CHU d'Angers
Verified postcode
Angers, France· Recruiting
CH d'Angoulème
Verified postcode
Angoulême, France· Recruiting
CH d'Argenteuil
Verified postcode
Argenteuil, France· Recruiting
CH de Belfort
Verified postcode
Belfort, France· Recruiting
CHU de Besançon
Verified postcode
Besançon, France· Recruiting
CH de Béthune
Verified postcode
Béthune, France· Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Verified postcode
Bordeaux, France· Recruiting
Centre Hospitalier William Morey
Verified postcode
Chalon-sur-Saône, France· Recruiting
CH de Cholet
Verified postcode
Cholet, France· Recruiting

Common questions

What is 'mechanical ventilation'?

Mechanical ventilation means you are using a machine to help you breathe, often called a breathing machine or ventilator, usually needed when you are very unwell.

What is 'rehabilitation' in this study?

In this study, rehabilitation is a special programme of personalised healthy eating plans and physical exercises to help you get your strength back and recover after your illness.

Who is paying for this study?

The study is for people covered by the French public health-insurance system, which suggests public funding or support within France.

Will I get special treatment if I join?

You will either get the special early and extended rehabilitation programme or the usual care provided by the hospital, as determined by a random process to ensure fair comparison.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, and this will not affect the medical care you receive.

How to find out more

Diane MAUGARS

diane.maugars@chu-nantes.fr +33(0)253482473 Official trial record

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