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

NCT06581939 | Recruiting DMC

• 1 other identifier: RC23_0585
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 52

Brief Summary

The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term outcomes of critical-illness survivors, compared to usual care. From ICU admission to recovery at home, the trial patients will receive either usual care or the early extended rehabilitation program. Usual care will consist in nutritional support and physiotherapy according to usual local practice in each participating ICU. The early extended program will consist of nutritional therapy, physiotherapy, and physical activity according to a standardized protocol tailored to general- and muscle-health improvements achieved in each individual patient over time.

Conditions

Mechanical Ventilation

Keywords

Critical care; Nutritional support; Mechanical ventilation; Shock; Macronutrients; Rehabilitation; Physiotherapy; Adapted physical activity

Outcome Measures

Primary Outcomes (1)

• 6-minute-walk distance

  The primary endpoint is the 6-minute-walk distance (6MWD), in meters, assessed by blinded physicians and research nurses during a hospital visit 6 months after randomization.

  6 months

Secondary Outcomes (32)

• Handgrip strength

  6 months after randomization

• Medical Research Council (MRC) score

  6 months after randomization

• Muscle mass assessed by the mid-arm muscle circumference (MAMC)

  6 months after randomization

• Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)

  3 months after randomization

• Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)

  4 months after randomization

Other Outcomes (15)

• Hospital Anxiety and Depression Scale (HADS)

  6 and 12 months

• Post-traumatic stress disorder Check List for DSM-5 (PCL-5)

  6 and 12 months

• Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC10)

  6 and 12 months

Study Arms (2)

Rehabilitation group

EXPERIMENTAL

Individualized rehabilitation program

Procedure: Rehabilitation group

Control group

ACTIVE COMPARATOR

Usual care

Procedure: Control group

Interventions

Rehabilitation group PROCEDURE

In the rehabilitation group, patients will follow an individualized rehabilitation program started early in the ICU and continued in the post-ICU ward then at home for 12 weeks, combining goal-directed nutrition and physical activity, tailored to gains made over time by each patient, with the involvement of dieticians, physiotherapists, and adapted-physical-activity instructors.

Rehabilitation group

Control group PROCEDURE

In the control group, patients will receive usual care from day-0 to day-180.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive mechanical ventilation (MV) started in the ICU within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, and expected to be required for at least 48 hours after randomization
• Treatment with a vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
• Nutritional support expected to be started within 24 h after intubation (or within 24 h after ICU admission if intubation occurred before ICU admission)
• Age 18 or older
• Covered by the French public health-insurance system

You may not qualify if:

• MV started more than 24 hours earlier
• Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition for chronic bowel disease
• Dying patient, do-not-resuscitate order, or other treatment- limitation decision at ICU admission
• Social circumstances hindering follow-up and telephone/video consultations (no fixed address, non-European residence)
• Inability to provide a stable personal mobile phone number (temporary number or not in the owner's name)
• Communication difficulties via telephone or video consultation (pre-existing severe hearing or visual impairment)
• Pre-existing chronic illness with life expectancy \<6 months
• Pre-existing cognitive impairment
• Pre-existing spinal injury
• Inability to walk before the critical illness
• Acute or chronic neuromuscular disease
• Brain injury, e.g., due to cardiac arrest, stroke, or severe trauma
• Pregnancy, recent delivery, or lactation
• Adult under guardianship
• Correctional facility inmate

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (52)

CH d'Albi

Albi, 81013, France

RECRUITING

CHU d'Amiens - Site Sud

Amiens, 80054, France

RECRUITING

CHU d'Amiens

Amiens, 80054, France

RECRUITING

CHU d'Angers

Angers, 49933, France

RECRUITING

CH d'Angoulème

Angoulême, 16959, France

RECRUITING

CH d'Argenteuil

Argenteuil, 95100, France

RECRUITING

CH de Belfort

Belfort, 90015, France

RECRUITING

CHU de Besançon

Besançon, 25030, France

RECRUITING

CH de Béthune

Béthune, 62408, France

RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier William Morey

Chalon-sur-Saône, 71100, France

RECRUITING

CH de Cholet

Cholet, 49325, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

CH de Dieppe

Dieppe, 76202, France

RECRUITING

CHU de Dijon

Dijon, 21079, France

RECRUITING

CH d'Annecy Genevois

Épagny, 74370, France

RECRUITING

Centre Hospitalier Sud Essonne

Étampes, 91150, France

RECRUITING

Hôpital Raymond Poincaré - AP-HP

Garches, 92380, France

RECRUITING

CHU de Grenoble

Grenoble, 38043, France

RECRUITING

CH d'Haguenau

Haguenau, 67504, France

RECRUITING

CH de Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

Hôpital de Bicêtre - AP-HP

Le Kremlin-Bicêtre, 94275, France

RECRUITING

CH du Mans

Le Mans, 72037, France

RECRUITING

CH de Lens

Lens, 62300, France

RECRUITING

CHRU de Lille

Lille, 59037, France

RECRUITING

CH de Lomme

Lomme, 59462, France

RECRUITING

CH de Lorient

Lorient, 56100, France

RECRUITING

CHU de Lyon

Lyon, 69437, France

RECRUITING

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

CHU de Nantes

Nantes, 44000, France

RECRUITING

CHU de Nice - Hôpital Pasteur

Nice, 06100, France

RECRUITING

CHU de Nice

Nice, 06200, France

RECRUITING

CH d'Orléans

Orléans, 45100, France

RECRUITING

Hôpital Saint-Louis - AP-HP

Paris, 75010, France

RECRUITING

Hôpital Cochin - AP-HP

Paris, 75014, France

RECRUITING

Hôpital la Pitié-Salpétrière - AP-HP

Paris, 75651, France

RECRUITING

Hôpital Tenon - AP-HP

Paris, 75970, France

RECRUITING

CHU de Reims

Reims, 51092, France

RECRUITING

CHU de Rennes

Rennes, 35033, France

RECRUITING

CHU de Rouen

Rouen, 76000, France

RECRUITING

CH de Saint-Brieuc

Saint-Brieuc, 22027, France

RECRUITING

Hôpital Delafontaine

Saint-Denis, 93200, France

RECRUITING

Centre Hospitalier de Saint-Nazaire

Saint-Nazaire, 44600, France

RECRUITING

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

RECRUITING

CH de Saint-Malo

St-Malo, 35403, France

RECRUITING

CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, 67091, France

RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67200, France

RECRUITING

Hôpital Foch

Suresnes, 92150, France

RECRUITING

CHU de Tours

Tours, 37044, France

RECRUITING

CH de Valenciennes

Valenciennes, 59322, France

RECRUITING

CH de Vannes

Vannes, 56017, France

RECRUITING

CH de Verdun

Verdun, 55100, France

RECRUITING

MeSH Terms

Conditions

Shock

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jean REIGNIER, MD, PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane MAUGARS

CONTACT

+33(0)253482473; diane.maugars@chu-nantes.fr

Carole OUISSE

CONTACT

+33(0)244768205; carole.ouisse@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 3, 2024
• Study Start: December 14, 2024
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): December 14, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (52)