What is this study testing for patients who received mechanical ventilation in the ICU?

This study is testing whether an early and extended rehabilitation program combining tailored nutrition and physical activity improves long-term recovery compared to usual care. Researchers want to see if this personalized approach helps patients regain strength and function after critical illness. The trial is led by Nantes University Hospital and involves multiple centers.

Who may be eligible for this mechanical ventilation clinical trial?

Adults aged 18 or older who started invasive mechanical ventilation within the past 24 hours and are receiving vasoactive treatment for shock may be eligible. Patients must be covered by French public health insurance and able to consent or have next-of-kin consent. Please review eligibility criteria for more details.

Is there any cost to participate in this mechanical ventilation clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, any personal travel or related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for these potential costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06581939

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

Led by Nantes University Hospital · Updated on 2026-01-23

830

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how an early and extended rehabilitation program that combines personalized nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for patients who have undergone invasive mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this tailored rehabilitation program to usual care, aiming to support recovery from critical illness. The study is a multicenter randomized controlled trial led by Nantes University Hospital. Participants will be assigned randomly to either the rehabilitation group or the usual care group. Those in the rehabilitation group receive a customized program starting early in the ICU and continuing through the post-ICU ward and at home for 12 weeks. This program involves goal-directed nutrition and physical activities adjusted to each patients progress, with support from dieticians, physiotherapists, and physical activity instructors. The usual care group receives standard nutritional support and physiotherapy based on local practices from day 0 to day 180. Throughout the study, participants will undergo various assessments including walking distance measured by a 6-minute walk test at 6 months, muscle strength, muscle mass, physical activity levels, calorie and protein intake, body weight, mortality rates, blood glucose monitoring, and quality of life surveys. These evaluations occur at multiple time points during and after hospitalization, up to one year. The study includes careful monitoring of mechanical ventilation duration, infections, hospital stay lengths, and other safety outcomes. Participant involvement spans from ICU admission through long-term follow-up.

CONDITIONS

Brief 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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Invasive mechanical ventilation started in the ICU within the past 24 hours or before ICU admission with ICU admission within the past 24 hours, and expected to continue for at least 48 hours after randomization
Treatment with a vasoactive agent (adrenaline, dobutamine, or noradrenaline) for shock
Nutritional support expected to start within 24 hours after intubation or ICU admission
Age 18 years or older
Patient or next-of-kin informed about the trial and consented to participate; emergency inclusion allowed if patient unable to consent and no next-of-kin available
Covered by the French public health-insurance system

You will not qualify if you...

Mechanical ventilation started more than 24 hours earlier
Specific nutritional needs such as long-term home enteral or parenteral nutrition for chronic bowel disease
Dying patient, do-not-resuscitate order, or treatment limitation decision at ICU admission
Social circumstances that prevent follow-up or telephone/video consultations (no fixed address, non-European residence)
Inability to provide a stable personal mobile phone number
Communication difficulties via phone or video (severe hearing or visual impairment)
Pre-existing chronic illness with life expectancy less than 6 months
Pre-existing cognitive impairment
Pre-existing spinal injury
Inability to walk before critical illness
Acute or chronic neuromuscular disease
Brain injury 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 comparing rehabilitation programs during critical illness

Research Team

Diane MAUGARS

Carole OUISSE

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