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Impacto de um programa de reabilitação precoce e ampliado que combina nutrição e atividades físicas personalizadas individualmente nos resultados dos pacientes após ventilação mecânica invasiva e terapia vasopressora na UTI (NUTRIREA-4)

29 de setembro de 2026 atualizado por: Nantes University Hospital

Impacto de um programa de reabilitação precoce e estendido que combina nutrição e atividades físicas personalizadas individualmente nos resultados dos pacientes após ventilação mecânica invasiva e terapia vasopressora na UTI: um ensaio multicêntrico randomizado controlado

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

830

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Rehabilitation group

Individualized rehabilitation program
Procedimento: 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 Ativo: Control group

Usual care
Procedimento: Control group

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
6-minute-walk distance
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Handgrip strength
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 12 months after randomization

IPAQ-SF score at 12 months after randomization
12 months after randomization
Calorie intakes
Prazo: 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
Prazo: 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
Prazo: 6 months

Mean changes in body weight measured at 6 months)
6 months
Mortality rates
Prazo: Day 90

90-day mortality rates
Day 90
Mortality rates
Prazo: 6 months

6-month mortality rates
6 months
Mortality rates
Prazo: 12 months

12-months mortality rates
12 months
Hypoglycemia
Prazo: 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
Prazo: 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)
Prazo: 6 and 12 months

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

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

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

ICU discharge mortality rates
ICU discharge, an average of 10 days
Mechanical Ventilation (MV) duration
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Hospital discharge, an average of 20 days

Hospital discharge mortality rates
Hospital discharge, an average of 20 days
Insulin
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Hospital Anxiety and Depression Scale (HADS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 6 and 12 months

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

Semi-structured interviews
12 months
Time course of circulating Growth-differentiation factor-15 (GDF-15)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Inclusion, H24, H72, Day7, ICU discharge, Day 180

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Nantes University Hospital

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

14 de dezembro de 2024

Conclusão Primária (Estimado)

14 de dezembro de 2027

Conclusão do estudo (Estimado)

14 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

20 de agosto de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de agosto de 2024

Primeira postagem (Real)

3 de setembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RC23_0585

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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