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NCT Number: NCT06581939

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

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.

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Key information

Conditions

Mechanical Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH d'Albi, Albi, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation group

Procedure

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

Procedure

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

Primary outcomes

  1. 6-minute-walk distance

    Time frame: 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.

Secondary outcomes

  1. Handgrip strength

    Time frame: 6 months after randomization

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

  2. Medical Research Council (MRC) score

    Time frame: 6 months after randomization

    MRC score at 6 months after randomization

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

    Time frame: 6 months after randomization

    MAMC at 6 months after randomization

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

    Time frame: 3 months after randomization

    IPAQ-SF score at 3 months after randomization

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

    Time frame: 4 months after randomization

    IPAQ-SF score at 4 months after randomization

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

    Time frame: 5 months after randomization

    IPAQ-SF score at 5 months after randomization

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

    Time frame: 6 months after randomization

    IPAQ-SF score at 6 months after randomization

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

    Time frame: 12 months after randomization

    IPAQ-SF score at 12 months after randomization

  9. Calorie intakes

    Time frame: 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)

  10. Protein intakes

    Time frame: 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)

  11. Body weight

    Time frame: 6 months

    Mean changes in body weight measured at 6 months)

  12. Mortality rates

    Time frame: Day 90

    90-day mortality rates

  13. Mortality rates

    Time frame: 6 months

    6-month mortality rates

  14. Mortality rates

    Time frame: 12 months

    12-months mortality rates

  15. Hypoglycemia

    Time frame: From day 0 to day 7

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

  16. Blood glucose

    Time frame: From day 0 to day 7

    Mean blood glucose from day 0 to day 7

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

    Time frame: 6 and 12 months

    SF-36 scores 6 and 12 months after randomization

  18. Handgrip strength

    Time frame: ICU discharge, an average of 10 days

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

  19. Handgrip strength

    Time frame: Hospital discharge, an average of 20 days

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

  20. Medical Research Council (MRC) score

    Time frame: ICU discharge, an average of 10 days

    MRC score at ICU discharge

  21. Medical Research Council (MRC) score

    Time frame: Hospital discharge, an average of 20 days

    MRC score at hospital discharge

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

    Time frame: ICU discharge, an average of 10 days

    MAMC at ICU discharge

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

    Time frame: Hospital discharge, an average of 20 days

    MAMC at hospital discharge

  24. Body weight

    Time frame: ICU discharge, an average of 10 days

    Mean changes in body weight measured at ICU discharge

  25. Mortality rates

    Time frame: ICU discharge, an average of 10 days

    ICU discharge mortality rates

  26. Mechanical Ventilation (MV) duration

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

    Days of MV

  27. ICU-acquired infection

    Time frame: 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

  28. ICU and hospital stay lengths

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

    ICU and hospital stay lengths (days)

  29. Mortality rates

    Time frame: Hospital discharge, an average of 20 days

    Hospital discharge mortality rates

  30. Insulin

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

    Days on insulin in the ICU

  31. Delay from randomization to first standing-up

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

    Delay from randomization to first standing-up (days)

  32. Delay from randomization to first walking

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

    Delay from randomization to first walking (days)

Other outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6 and 12 months

    HADS score 6 and 12 months after randomization

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

    Time frame: 6 and 12 months

    PCL-5 score 6 and 12 months after randomization

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

    Time frame: 6 and 12 months

    CD-RISC-10 6 and 12 months after randomization

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

    Time frame: 6 and 12 months

    PTGI-SF 6 and 12 months after randomization

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

    Time frame: 6 and 12 months

    MoCA 6 and 12 months after randomization

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

    Time frame: 12 months

    Semi-structured interviews

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

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

    GDF-15 plasma level

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

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

    IFN-γ plasma level

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

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

    IL-1β plasma level

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

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

    IL-6 plasma level

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

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

    TNF-α plasma level

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

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

    FGF-21 plasma level

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

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

    leptin plasma level

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

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

    C-peptide plasma level

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

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

    Ghrelin plasma level

Study contacts

Contact information is provided by the study sponsor or research team.

Carole OUISSE

CONTACT

[email protected]

+33(0)244768205

Diane MAUGARS

CONTACT

[email protected]

+33(0)253482473

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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 : A Multicenter Randomized Controlled Trial

Acronym: NUTRIREA-4

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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