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

Official 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

Overview

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.

Interventions

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

Primary outcome measures

• 6-minute-walk distance [Time frame: 6 months]

Secondary outcome measures (12)

• Handgrip strength [Time frame: 6 months after randomization]
• Medical Research Council (MRC) score [Time frame: 6 months after randomization]
• Muscle mass assessed by the mid-arm muscle circumference (MAMC) [Time frame: 6 months after randomization]
• Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) [Time frame: 3 months after randomization]
• Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) [Time frame: 4 months after randomization]
• Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) [Time frame: 5 months after randomization]
• Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) [Time frame: 6 months after randomization]
• Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF) [Time frame: 12 months after randomization]
• Calorie intakes [Time frame: From day 0 to 12 months]
• Protein intakes [Time frame: From day 0 to 12 months]
• Body weight [Time frame: 6 months]
• Mortality rates [Time frame: Day 90]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 52 centers

• CH d'Albi — Albi
• CHU d'Amiens - Site Sud — Amiens
• CHU d'Amiens — Amiens
• CHU d'Angers — Angers
• CH d'Angoulème — Angoulême
• CH d'Argenteuil — Argenteuil
• CH de Belfort — Belfort
• CHU de Besançon — Besançon
• … and 44 more centers

Identifiers

NCT: NCT06581939 · RC23_0585

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗