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
NCT ID: NCT06581939
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
830 participants
INTERVENTIONAL
2024-12-14
2027-12-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Rehabilitation group
Individualized rehabilitation program
Rehabilitation group
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.
Control group
Usual care
Control group
In the control group, patients will receive usual care from day-0 to day-180.
Interventions
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Rehabilitation group
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.
Control group
In the control group, patients will receive usual care from day-0 to day-180.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient and/or next-of-kin informed about the trial and having consented to participation in the trial. If the patient is unable to receive information and no next-of-kin can be contacted during screening for the trial, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law.
* Covered by the French public health-insurance system
Exclusion Criteria
* 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
* Institutionalized patient
* Prior inclusion in a randomized trial designed to compare rehabilitation programs delivered to patients during critical illness
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jean REIGNIER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CH d'Albi
Albi, , France
CHU d'Amiens - Site Sud
Amiens, , France
CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CH d'Angoulème
Angoulême, , France
CH d'Argenteuil
Argenteuil, , France
CH de Belfort
Belfort, , France
CHU de Besançon
Besançon, , France
CH de Béthune
Béthune, , France
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
CH de Cholet
Cholet, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CH de Dieppe
Dieppe, , France
CHU de Dijon
Dijon, , France
CH d'Annecy Genevois
Épagny, , France
Centre Hospitalier Sud Essonne
Étampes, , France
Hôpital Raymond Poincaré - AP-HP
Garches, , France
CHU de Grenoble
Grenoble, , France
CH d'Haguenau
Haguenau, , France
CH de Vendée
La Roche-sur-Yon, , France
Hôpital de Bicêtre - AP-HP
Le Kremlin-Bicêtre, , France
CH du Mans
Le Mans, , France
CH de Lens
Lens, , France
CHRU de Lille
Lille, , France
CH de Lomme
Lomme, , France
CH de Lorient
Lorient, , France
CHU de Lyon
Lyon, , France
CHU de Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
CHU de Nice - Hôpital Pasteur
Nice, , France
CHU de Nice
Nice, , France
CH d'Orléans
Orléans, , France
Hôpital Saint-Louis - AP-HP
Paris, , France
Hôpital Cochin - AP-HP
Paris, , France
Hôpital la Pitié-Salpétrière - AP-HP
Paris, , France
Hôpital Tenon - AP-HP
Paris, , France
CHU de Reims
Reims, , France
CHU de Rennes
Rennes, , France
CHU de Rouen
Rouen, , France
CH de Saint-Brieuc
Saint-Brieuc, , France
Hôpital Delafontaine
Saint-Denis, , France
Centre Hospitalier de Saint-Nazaire
Saint-Nazaire, , France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, , France
CH de Saint-Malo
St-Malo, , France
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, , France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
Hôpital Foch
Suresnes, , France
CHU de Tours
Tours, , France
CH de Valenciennes
Valenciennes, , France
CH de Vannes
Vannes, , France
CH de Verdun
Verdun, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC23_0585
Identifier Type: -
Identifier Source: org_study_id
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