NCT06581939招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 830
- 试验地点
- 52
- 主要终点
- 6-minute-walk distance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rehabilitation group
Experimental
Individualized rehabilitation program
干预措施: Rehabilitation group (Procedure)
Control group
Active Comparator
Usual care
干预措施: Control group (Procedure)
结局指标
主要结局
6-minute-walk distance
时间窗: 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.
次要结局
- Mortality rates(Hospital discharge, an average of 20 days)
- Hypoglycemia(From day 0 to day 7)
- Handgrip strength(6 months after randomization)
- Medical Research Council (MRC) score(6 months after randomization)
- Muscle mass assessed by the mid-arm muscle circumference (MAMC)(6 months after randomization)
- Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)(3 months after randomization)
- Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)(4 months after randomization)
- Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)(5 months after randomization)
- Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)(6 months after randomization)
- Body weight(6 months)
- Mortality rates(Day 90)
- Mortality rates(6 months)
- Mortality rates(12 months)
- Handgrip strength(ICU discharge, an average of 10 days)
- Medical Research Council (MRC) score(ICU discharge, an average of 10 days)
- Muscle mass assessed by the mid-arm muscle circumference (MAMC)(ICU discharge, an average of 10 days)
- Mortality rates(ICU discharge, an average of 10 days)
- Protein intakes(From day 0 to 12 months)
- Body weight(ICU discharge, an average of 10 days)
- Handgrip strength(Hospital discharge, an average of 20 days)
- Medical Research Council (MRC) score(Hospital discharge, an average of 20 days)
- Muscle mass assessed by the mid-arm muscle circumference (MAMC)(Hospital discharge, an average of 20 days)
- Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)(12 months after randomization)
- Calorie intakes(From day 0 to 12 months)
- Blood glucose(From day 0 to day 7)
- Quality of life assessed using the Short Form 36 Health Survey (SF-36)(6 and 12 months)
- Mechanical Ventilation (MV) duration(From D0 until the date of cessation of mechanical ventilation, an average of 7 days)
- ICU-acquired infection(From day 0 until the date of discharge from ICU, an average of 10 days)
- ICU and hospital stay lengths(From day 0 until the day of discharge from hospital, an average of 20 days)
- Insulin(From day 0 until the date of ICU discharge, an average of 10 days)
- Delay from randomization to first standing-up(From date of randomization until the date of first standing-up, an average of 7 days)
- Delay from randomization to first walking(From date of randomization until the date of first walking, an average of 15 days)
研究者
研究点 (52)
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