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
NCT Number: NCT06581939
Acronym: NUTRIREA-4
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mechanical Ventilation
Sponsor: Nantes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 830
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2027-10-01

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.

Primary Outcome Measures: 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., 6 months
Secondary Outcome Measures: Handgrip strength, Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization, 6 months after randomization|Medical Research Council (MRC) score, MRC score at 6 months after randomization, 6 months after randomization|Muscle mass assessed by the mid-arm muscle circumference (MAMC), MAMC at 6 months after randomization, 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, 3 months after randomization|Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF), 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), 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), 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), IPAQ-SF score at 12 months after randomization, 12 months after randomization|Calorie intakes, 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, 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, Mean changes in body weight measured at 6 months), 6 months|Mortality rates, 90-day mortality rates, Day 90|Mortality rates, 6-month mortality rates, 6 months|Mortality rates, 12-months mortality rates, 12 months|Hypoglycemia, Proportion of patients with at least one hypoglycemia from day 0 to day 7, From day 0 to day 7|Blood glucose, 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), SF-36 scores 6 and 12 months after randomization, 6 and 12 months|Hospital Anxiety and Depression Scale (HADS), HADS score 6 and 12 months after randomization, 6 and 12 months|Post-traumatic stress disorder Check List for DSM-5 (PCL-5), PCL-5 score 6 and 12 months after randomization, 6 and 12 months|Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC10)., CD-RISC-10 6 and 12 months after randomization, 6 and 12 months|Posttraumatic growth using the Posttraumatic Growth Inventory Short Form (PTGI-SF), PTGI-SF 6 and 12 months after randomization, 6 and 12 months|Cognitive performance using the Montreal Cognitive Assessment (MoCA), MoCA 6 and 12 months after randomization, 6 and 12 months|Handgrip strength, Handgrip strength (Kg and percent of predicted strength) at ICU discharge, ICU discharge, an average of 10 days|Handgrip strength, Handgrip strength (Kg and percent of predicted strength) at hospital discharge, Hospital discharge, an average of 20 days|Medical Research Council (MRC) score, MRC score at ICU discharge, ICU discharge, an average of 10 days|Medical Research Council (MRC) score, MRC score at hospital discharge, Hospital discharge, an average of 20 days|Muscle mass assessed by the mid-arm muscle circumference (MAMC), MAMC at ICU discharge, ICU discharge, an average of 10 days|Muscle mass assessed by the mid-arm muscle circumference (MAMC), MAMC at hospital discharge, Hospital discharge, an average of 20 days|Body weight, Mean changes in body weight measured at ICU discharge, ICU discharge, an average of 10 days|Mortality rates, ICU discharge mortality rates, ICU discharge, an average of 10 days|Mechanical Ventilation (MV) duration, Days of MV, From D0 until the date of cessation of mechanical ventilation, an average of 7 days|ICU-acquired infection, 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, ICU and hospital stay lengths (days), From day 0 until the day of discharge from hospital, an average of 20 days|Mortality rates, Hospital discharge mortality rates, Hospital discharge, an average of 20 days|Insulin, 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, 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, Delay from randomization to first walking (days), From date of randomization until the date of first walking, an average of 15 days