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Impacto de un programa de rehabilitación temprana y prolongada que combina nutrición y actividades físicas adaptadas individualmente en los resultados de los pacientes después de la ventilación mecánica invasiva y la terapia vasopresora en la UCI (NUTRIREA-4)

29 de septiembre de 2026 actualizado por: Nantes University Hospital

Impacto de un programa de rehabilitación temprana y prolongada que combina nutrición y actividades físicas personalizadas en los resultados de los pacientes después de la ventilación mecánica invasiva y la terapia vasopresora en la UCI: un ensayo controlado aleatorio multicéntrico

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

830

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Francia
      • Albi, Francia, 81013
      • Amiens, Francia, 80054
      • Amiens, Francia, 80054
      • Angers, Francia, 49933
      • Angoulême, Francia, 16959
      • Argenteuil, Francia, 95100
      • Belfort, Francia, 90015
      • Besançon, Francia, 25030
      • Bordeaux, Francia, 33000
      • Béthune, Francia, 62408
      • Chalon-sur-Saône, Francia, 71100
        • Reclutamiento
        • Centre Hospitalier William Morey
        • Contacto:
      • Cholet, Francia, 49325
      • Clermont-Ferrand, Francia, 63003
      • Dieppe, Francia, 76202
        • Reclutamiento
        • CH de Dieppe
        • Contacto:
      • Dijon, Francia, 21079
      • Garches, Francia, 92380
        • Reclutamiento
        • Hôpital Raymond Poincaré - AP-HP
        • Contacto:
      • Grenoble, Francia, 38043
      • Haguenau, Francia, 67504
      • La Roche-sur-Yon, Francia, 85925
      • Le Kremlin-Bicêtre, Francia, 94275
        • Reclutamiento
        • Hôpital de Bicêtre - AP-HP
        • Contacto:
      • Le Mans, Francia, 72037
      • Lens, Francia, 62300
        • Reclutamiento
        • CH de Lens
        • Contacto:
      • Lille, Francia, 59037
      • Lomme, Francia, 59462
      • Lorient, Francia, 56100
        • Reclutamiento
        • CH de Lorient
        • Contacto:
      • Lyon, Francia, 69437
      • Montpellier, Francia, 34295
      • Nantes, Francia, 44000
        • Reclutamiento
        • CHU de Nantes
        • Contacto:
      • Nice, Francia, 06100
        • Reclutamiento
        • CHU de Nice - Hôpital Pasteur
        • Contacto:
      • Nice, Francia, 06200
      • Orléans, Francia, 45100
      • Paris, Francia, 75014
      • Paris, Francia, 75010
        • Reclutamiento
        • Hôpital Saint-Louis - AP-HP
        • Contacto:
      • Paris, Francia, 75651
        • Reclutamiento
        • Hôpital la Pitié-Salpétrière - AP-HP
        • Contacto:
      • Paris, Francia, 75970
      • Reims, Francia, 51092
      • Rennes, Francia, 35033
      • Rouen, Francia, 76000
      • Saint-Brieuc, Francia, 22027
      • Saint-Denis, Francia, 93200
      • Saint-Nazaire, Francia, 44600
      • Saint-Priest-en-Jarez, Francia, 42270
      • St-Malo, Francia, 35403
        • Reclutamiento
        • CH de Saint-Malo
        • Contacto:
      • Strasbourg, Francia, 67091
      • Strasbourg, Francia, 67200
      • Suresnes, Francia, 92150
      • Tours, Francia, 37044
      • Valenciennes, Francia, 59322
      • Vannes, Francia, 56017
      • Verdun, Francia, 55100
        • Reclutamiento
        • CH de Verdun
        • Contacto:
      • Épagny, Francia, 74370
      • Étampes, Francia, 91150

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 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
  • 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:

  • 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
  • Institutionalized patient
  • Prior inclusion in a randomized trial designed to compare rehabilitation programs delivered to patients during critical illness

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Rehabilitation group

Individualized rehabilitation program
Procedimiento: 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.
Comparador activo: Control group

Usual care
Procedimiento: Control group

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6-minute-walk distance
Periodo de tiempo: 6 months

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Handgrip strength
Periodo de tiempo: 6 months after randomization

Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization
6 months after randomization
Medical Research Council (MRC) score
Periodo de tiempo: 6 months after randomization

MRC score at 6 months after randomization
6 months after randomization
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
Periodo de tiempo: 6 months after randomization

MAMC at 6 months after randomization
6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Periodo de tiempo: 3 months after randomization

IPAQ-SF score at 3 months after randomization
3 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Periodo de tiempo: 4 months after randomization

IPAQ-SF score at 4 months after randomization
4 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Periodo de tiempo: 5 months after randomization

IPAQ-SF score at 5 months after randomization
5 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Periodo de tiempo: 6 months after randomization

IPAQ-SF score at 6 months after randomization
6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Periodo de tiempo: 12 months after randomization

IPAQ-SF score at 12 months after randomization
12 months after randomization
Calorie intakes
Periodo de tiempo: From day 0 to 12 months

Calorie intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
From day 0 to 12 months
Protein intakes
Periodo de tiempo: From day 0 to 12 months

Protein intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
From day 0 to 12 months
Body weight
Periodo de tiempo: 6 months

Mean changes in body weight measured at 6 months)
6 months
Mortality rates
Periodo de tiempo: Day 90

90-day mortality rates
Day 90
Mortality rates
Periodo de tiempo: 6 months

6-month mortality rates
6 months
Mortality rates
Periodo de tiempo: 12 months

12-months mortality rates
12 months
Hypoglycemia
Periodo de tiempo: From day 0 to day 7

Proportion of patients with at least one hypoglycemia from day 0 to day 7
From day 0 to day 7
Blood glucose
Periodo de tiempo: From day 0 to day 7

Mean blood glucose from day 0 to day 7
From day 0 to day 7
Quality of life assessed using the Short Form 36 Health Survey (SF-36)
Periodo de tiempo: 6 and 12 months

SF-36 scores 6 and 12 months after randomization
6 and 12 months
Handgrip strength
Periodo de tiempo: ICU discharge, an average of 10 days

Handgrip strength (Kg and percent of predicted strength) at ICU discharge
ICU discharge, an average of 10 days
Handgrip strength
Periodo de tiempo: Hospital discharge, an average of 20 days

Handgrip strength (Kg and percent of predicted strength) at hospital discharge
Hospital discharge, an average of 20 days
Medical Research Council (MRC) score
Periodo de tiempo: ICU discharge, an average of 10 days

MRC score at ICU discharge
ICU discharge, an average of 10 days
Medical Research Council (MRC) score
Periodo de tiempo: Hospital discharge, an average of 20 days

MRC score at hospital discharge
Hospital discharge, an average of 20 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
Periodo de tiempo: ICU discharge, an average of 10 days

MAMC at ICU discharge
ICU discharge, an average of 10 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
Periodo de tiempo: Hospital discharge, an average of 20 days

MAMC at hospital discharge
Hospital discharge, an average of 20 days
Body weight
Periodo de tiempo: ICU discharge, an average of 10 days

Mean changes in body weight measured at ICU discharge
ICU discharge, an average of 10 days
Mortality rates
Periodo de tiempo: ICU discharge, an average of 10 days

ICU discharge mortality rates
ICU discharge, an average of 10 days
Mechanical Ventilation (MV) duration
Periodo de tiempo: From D0 until the date of cessation of mechanical ventilation, an average of 7 days

Days of MV
From D0 until the date of cessation of mechanical ventilation, an average of 7 days
ICU-acquired infection
Periodo de tiempo: From day 0 until the date of discharge from ICU, an average of 10 days

Proportion of patients with at least one ICU-acquired infection
From day 0 until the date of discharge from ICU, an average of 10 days
ICU and hospital stay lengths
Periodo de tiempo: From day 0 until the day of discharge from hospital, an average of 20 days

ICU and hospital stay lengths (days)
From day 0 until the day of discharge from hospital, an average of 20 days
Mortality rates
Periodo de tiempo: Hospital discharge, an average of 20 days

Hospital discharge mortality rates
Hospital discharge, an average of 20 days
Insulin
Periodo de tiempo: From day 0 until the date of ICU discharge, an average of 10 days

Days on insulin in the ICU
From day 0 until the date of ICU discharge, an average of 10 days
Delay from randomization to first standing-up
Periodo de tiempo: From date of randomization until the date of first standing-up, an average of 7 days

Delay from randomization to first standing-up (days)
From date of randomization until the date of first standing-up, an average of 7 days
Delay from randomization to first walking
Periodo de tiempo: From date of randomization until the date of first walking, an average of 15 days

Delay from randomization to first walking (days)
From date of randomization until the date of first walking, an average of 15 days

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: 6 and 12 months

HADS score 6 and 12 months after randomization
6 and 12 months
Post-traumatic stress disorder Check List for DSM-5 (PCL-5)
Periodo de tiempo: 6 and 12 months

PCL-5 score 6 and 12 months after randomization
6 and 12 months
Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC10)
Periodo de tiempo: 6 and 12 months

CD-RISC-10 6 and 12 months after randomization
6 and 12 months
Posttraumatic growth using the Posttraumatic Growth Inventory Short Form (PTGI-SF)
Periodo de tiempo: 6 and 12 months

PTGI-SF 6 and 12 months after randomization
6 and 12 months
Cognitive performance using the Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: 6 and 12 months

MoCA 6 and 12 months after randomization
6 and 12 months
Qualitative assessment on how the rehabilitation program influences resilience and psychological recovery after ICU
Periodo de tiempo: 12 months

Semi-structured interviews
12 months
Time course of circulating Growth-differentiation factor-15 (GDF-15)
Periodo de tiempo: Inclusion, H24, H72, Day 7, ICU discharge, Day 180

GDF-15 plasma level
Inclusion, H24, H72, Day 7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on IFN-γ
Periodo de tiempo: Inclusion, H24, H72, Day7, ICU discharge, Day 180

IFN-γ plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on IFN-γ
Periodo de tiempo: Inclusion, H24, H72, Day7, ICU discharge, Day 180.

IL-1β plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180.
Effects of the individualized rehabilitation program, compared to usual care, on IL-6
Periodo de tiempo: Inclusion, H24, H72, Day7, ICU discharge, Day 180

IL-6 plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on TNF-α
Periodo de tiempo: Inclusion, H24, H72, Day7, ICU discharge, Day 180

TNF-α plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on FGF-21
Periodo de tiempo: Inclusion, H24, H72, Day7, ICU discharge, Day 180

FGF-21 plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on leptin
Periodo de tiempo: Inclusion, H24, H72, Day7, ICU discharge, Day 180

leptin plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on C-peptide
Periodo de tiempo: inclusion, H24, H72, Day7, ICU discharge, Day 180

C-peptide plasma level
inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on Ghrelin
Periodo de tiempo: Inclusion, H24, H72, Day7, ICU discharge, Day 180

Ghrelin plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Nantes University Hospital

Investigadores

  • Investigador principal: Jean REIGNIER, MD, PhD, Nantes University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de diciembre de 2024

Finalización primaria (Estimado)

14 de diciembre de 2027

Finalización del estudio (Estimado)

14 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2024

Primero enviado que cumplió con los criterios de control de calidad

29 de agosto de 2024

Publicado por primera vez (Actual)

3 de septiembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RC23_0585

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data underlying the demographic characteristics and primary and secondary outcomes reported in the main publication, together with the data dictionary.

Marco de tiempo para compartir IPD

From 6 months after publication of the main trial results, for a period of 3 years

Criterios de acceso compartido de IPD

Data will be shared with qualified academic researchers upon reasonable request submitted to the principal investigator. Requests must include a scientifically sound research proposal and a signed Data Use Agreement (DUA).

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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