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RecruitingNCT06581939NUTRIREA-4Updated Oct 2, 2026

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

An interventional study of Rehabilitation group and Control group in Mechanical Ventilation, sponsored by Nantes University Hospital. Recruiting at 52 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Updated Oct 2, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
830
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mechanical Ventilation

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Keywords

  • Critical care
  • Nutritional support
  • Mechanical ventilation
  • Shock
  • Macronutrients
  • Rehabilitation
  • Physiotherapy
  • Adapted physical activity
03

In context

Shock

487 studies on the registry are indexed under Shock; 107 are open to participants now.

This study's planned enrollment of 830 is above the median of 100 across 229 interventional studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

Browse Nantes University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 \<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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
830 participants (estimated)

Study arms

  • Experimental
    Rehabilitation group

    Individualized rehabilitation program

    Procedure: Rehabilitation group

  • Active comparator
    Control group

    Usual care

    Procedure: Control group

Interventions

  • ProcedureRehabilitation 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.

  • ProcedureControl group

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

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Handgrip strength

    Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization

    Time frame: 6 months after randomization

  2. Medical Research Council (MRC) score

    MRC score at 6 months after randomization

    Time frame: 6 months after randomization

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

    MAMC at 6 months after randomization

    Time frame: 6 months after randomization

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

    IPAQ-SF score at 3 months after randomization

    Time frame: 3 months after randomization

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

    IPAQ-SF score at 4 months after randomization

    Time frame: 4 months after randomization

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

    IPAQ-SF score at 5 months after randomization

    Time frame: 5 months after randomization

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

    IPAQ-SF score at 6 months after randomization

    Time frame: 6 months after randomization

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

    IPAQ-SF score at 12 months after randomization

    Time frame: 12 months after randomization

  9. Calorie intakes

    Calorie intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)

    Time frame: From day 0 to 12 months

  10. Protein intakes

    Protein intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)

    Time frame: From day 0 to 12 months

  11. Body weight

    Mean changes in body weight measured at 6 months)

    Time frame: 6 months

  12. Mortality rates

    90-day mortality rates

    Time frame: Day 90

  13. Mortality rates

    6-month mortality rates

    Time frame: 6 months

  14. Mortality rates

    12-months mortality rates

    Time frame: 12 months

  15. Hypoglycemia

    Proportion of patients with at least one hypoglycemia from day 0 to day 7

    Time frame: From day 0 to day 7

  16. Blood glucose

    Mean blood glucose from day 0 to day 7

    Time frame: From day 0 to day 7

  17. Quality of life assessed using the Short Form 36 Health Survey (SF-36)

    SF-36 scores 6 and 12 months after randomization

    Time frame: 6 and 12 months

  18. Handgrip strength

    Handgrip strength (Kg and percent of predicted strength) at ICU discharge

    Time frame: ICU discharge, an average of 10 days

  19. Handgrip strength

    Handgrip strength (Kg and percent of predicted strength) at hospital discharge

    Time frame: Hospital discharge, an average of 20 days

  20. Medical Research Council (MRC) score

    MRC score at ICU discharge

    Time frame: ICU discharge, an average of 10 days

  21. Medical Research Council (MRC) score

    MRC score at hospital discharge

    Time frame: Hospital discharge, an average of 20 days

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

    MAMC at ICU discharge

    Time frame: ICU discharge, an average of 10 days

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

    MAMC at hospital discharge

    Time frame: Hospital discharge, an average of 20 days

  24. Body weight

    Mean changes in body weight measured at ICU discharge

    Time frame: ICU discharge, an average of 10 days

  25. Mortality rates

    ICU discharge mortality rates

    Time frame: ICU discharge, an average of 10 days

  26. Mechanical Ventilation (MV) duration

    Days of MV

    Time frame: From D0 until the date of cessation of mechanical ventilation, an average of 7 days

  27. ICU-acquired infection

    Proportion of patients with at least one ICU-acquired infection

    Time frame: From day 0 until the date of discharge from ICU, an average of 10 days

  28. ICU and hospital stay lengths

    ICU and hospital stay lengths (days)

    Time frame: From day 0 until the day of discharge from hospital, an average of 20 days

  29. Mortality rates

    Hospital discharge mortality rates

    Time frame: Hospital discharge, an average of 20 days

  30. Insulin

    Days on insulin in the ICU

    Time frame: From day 0 until the date of ICU discharge, an average of 10 days

  31. Delay from randomization to first standing-up

    Delay from randomization to first standing-up (days)

    Time frame: From date of randomization until the date of first standing-up, an average of 7 days

  32. Delay from randomization to first walking

    Delay from randomization to first walking (days)

    Time frame: From date of randomization until the date of first walking, an average of 15 days

Other outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    HADS score 6 and 12 months after randomization

    Time frame: 6 and 12 months

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

    PCL-5 score 6 and 12 months after randomization

    Time frame: 6 and 12 months

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

    CD-RISC-10 6 and 12 months after randomization

    Time frame: 6 and 12 months

  4. Posttraumatic growth using the Posttraumatic Growth Inventory Short Form (PTGI-SF)

    PTGI-SF 6 and 12 months after randomization

    Time frame: 6 and 12 months

  5. Cognitive performance using the Montreal Cognitive Assessment (MoCA)

    MoCA 6 and 12 months after randomization

    Time frame: 6 and 12 months

  6. Qualitative assessment on how the rehabilitation program influences resilience and psychological recovery after ICU

    Semi-structured interviews

    Time frame: 12 months

  7. Time course of circulating Growth-differentiation factor-15 (GDF-15)

    GDF-15 plasma level

    Time frame: Inclusion, H24, H72, Day 7, ICU discharge, Day 180

  8. Effects of the individualized rehabilitation program, compared to usual care, on IFN-γ

    IFN-γ plasma level

    Time frame: Inclusion, H24, H72, Day7, ICU discharge, Day 180

  9. Effects of the individualized rehabilitation program, compared to usual care, on IFN-γ

    IL-1β plasma level

    Time frame: Inclusion, H24, H72, Day7, ICU discharge, Day 180.

  10. Effects of the individualized rehabilitation program, compared to usual care, on IL-6

    IL-6 plasma level

    Time frame: Inclusion, H24, H72, Day7, ICU discharge, Day 180

  11. Effects of the individualized rehabilitation program, compared to usual care, on TNF-α

    TNF-α plasma level

    Time frame: Inclusion, H24, H72, Day7, ICU discharge, Day 180

  12. Effects of the individualized rehabilitation program, compared to usual care, on FGF-21

    FGF-21 plasma level

    Time frame: Inclusion, H24, H72, Day7, ICU discharge, Day 180

  13. Effects of the individualized rehabilitation program, compared to usual care, on leptin

    leptin plasma level

    Time frame: Inclusion, H24, H72, Day7, ICU discharge, Day 180

  14. Effects of the individualized rehabilitation program, compared to usual care, on C-peptide

    C-peptide plasma level

    Time frame: inclusion, H24, H72, Day7, ICU discharge, Day 180

  15. Effects of the individualized rehabilitation program, compared to usual care, on Ghrelin

    Ghrelin plasma level

    Time frame: Inclusion, H24, H72, Day7, ICU discharge, Day 180

07

Study locations

52 of 52 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the demographic characteristics and primary and secondary outcomes reported in the main publication, together with the data dictionary.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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

Access criteria: 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).

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Jun 14, 2027→Dec 14, 2027
Oct 2, 2026
Study completion
Dec 14, 2027→Jun 14, 2028
Oct 2, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • CHU de Clermont-Ferrand · Clermont-Ferrand, FranceContact b•••@chu-clermontferrand.fr→c•••@chu-clermontferrand.fr
  • CHRU de Lille · Lille, FranceContact s•••@chru-lille.fr→c•••@chru-lille.fr
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Primary completion Jun 14, 2027→Dec 14, 2027
    Study completion Dec 14, 2027→Jun 14, 2028
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • CHU de Clermont-Ferrand · Clermont-Ferrand, FranceContact b•••@chu-clermontferrand.fr→c•••@chu-clermontferrand.fr
    • CHRU de Lille · Lille, FranceContact s•••@chru-lille.fr→c•••@chru-lille.fr
    + 2 other changes: verification date and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06581939
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Sep 3, 2024
Start date
Dec 14, 2024
Primary completion
Dec 14, 2027 (estimated)
Completion
Jun 14, 2028 (estimated)
Last update
Oct 2, 2026

Study contacts

Diane MAUGARS
Contact
diane.maugars@chu-nantes.fr
+33(0)253482473
Carole OUISSE
Contact
carole.ouisse@chu-nantes.fr
+33(0)244768205
Jean REIGNIER, MD, PhD
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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