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Indvirkningen af ​​et tidligt og udvidet rehabiliteringsprogram, der kombinerer individuelt tilpasset ernæring og fysiske aktiviteter på patientresultater efter invasiv mekanisk ventilation og vasopressorterapi på intensivafdelingen (NUTRIREA-4)

29. september 2026 opdateret af: Nantes University Hospital

Indvirkningen af ​​et tidligt og udvidet rehabiliteringsprogram, der kombinerer individuelt tilpasset ernæring og fysiske aktiviteter på patientresultater efter invasiv mekanisk ventilation og vasopressorterapi på intensivafdelingen: et multicenter randomiseret kontrolleret forsøg

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

830

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rehabilitation group

Individualized rehabilitation program
Procedure: 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.
Aktiv komparator: Control group

Usual care
Procedure: Control group

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6-minute-walk distance
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Handgrip strength
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 12 months after randomization

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

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

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

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

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

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

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

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

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

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 6 and 12 months

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

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

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Efterforskere

  • Ledende efterforsker: Jean REIGNIER, MD, PhD, Nantes University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. december 2024

Primær færdiggørelse (Anslået)

14. december 2027

Studieafslutning (Anslået)

14. juni 2028

Datoer for studieregistrering

Først indsendt

20. august 2024

Først indsendt, der opfyldte QC-kriterier

29. august 2024

Først opslået (Faktiske)

3. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC23_0585

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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).

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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