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.
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
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)
Parallel
Rehabilitation group
Procedure/SurgeryIn 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/SurgeryIn the control group, patients will receive usual care from day-0 to day-180.
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.
Handgrip strength
Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization
Medical Research Council (MRC) score
MRC score at 6 months after randomization
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
MAMC at 6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
IPAQ-SF score at 3 months after randomization
Hospital Anxiety and Depression Scale (HADS)
HADS score 6 and 12 months after randomization
Post-traumatic stress disorder Check List for DSM-5 (PCL-5)
PCL-5 score 6 and 12 months after randomization
Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC10)
CD-RISC-10 6 and 12 months after randomization
Posttraumatic growth using the Posttraumatic Growth Inventory Short Form (PTGI-SF)
PTGI-SF 6 and 12 months after randomization
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