Post Intensive Care Optimization Through Lifestyle Intervention

Обзор

The quality of the intensive care unit (ICU) has been steadily improving over the years. Although improvements in the acute treatment of critically ill patients have been made, a large number of ICU survivors suffer from severe physical, cognitive and mental health problems persisting months to years after leaving the ICU. Physical impairments occur the most and can be very severe, greatly affecting activities in daily life and subsequently the perceived quality of life of ICU survivors. Although there is an increased awareness of long-term complaints following ICU stay, there is currently a knowledge gap on how to enhance the recovery of ICU survivors 6 to 12 months post-ICU discharge. The overall objective of the current study is to establish the extent of health and functional improvements that can be obtained with an optimized, combined exercise and nutritional intervention in ICU survivors 6 to 12 months post-ICU discharge.

Вмешательства

• Поведенческое Combined exercise and nutritional intervention
  The intervention consists of a combined exercise and nutritional intervention. All subjects will perform 20 weeks of supervised resistance and endurance type exercise training 2 to 3 days per week. The dietary intervention aims to attain a diet that comprises sufficient protein and is otherwise in line with the Dutch Healthy Diet guidelines. In support, subjects will consume a daily high protein multi-nutrient supplement which will be ingested pre-sleep. There will be an additional supplement in

Первичные конечные точки

• Aerobic capacity [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
• Muscle strength [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
• Muscle mass [Срок оценки: At baseline (week 0) and at the end of the intervention (week 22)]

Вторичные конечные точки (12)

• Body fat composition [Срок оценки: At baseline (week 0) and at the end of the intervention (week 22)]
• Body lean mass composition [Срок оценки: At baseline (week 0) and at the end of the intervention (week 22)]
• Metabolic health [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
• Gut health [Срок оценки: In week 1, week 4 and week 21 of the intervention]
• Brain health (cognitive function) [Срок оценки: At baseline (week 0) and at the end of the intervention (week 22)]
• Step count [Срок оценки: In week 1, week 11 and week 21 of the intervention]
• Age [Срок оценки: At baseline (week 0)]
• Body mass [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
• Height [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
• Body Mass Index [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
• Waist circumference [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
• Systolic and diastolic blood pressure [Срок оценки: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]

Критерии участия

Критерии включения

• Aged 18 years and older
• Minimum ICU length of stay of 5 days and/or mechanically ventilated for a minimum of 2 days
• Persistent physical complaints
• Community-dwelling, living independently (non-assisted)
• Mentally competent with a Mini-Mental State Examination (MMSE) score of ≥24
• Willing to participate in a 20-week multimodal lifestyle intervention

Критерии исключения

• Any medical condition that may interfere with the safety of the subjects during exercise or any condition that interferes with assessment of the outcome parameters, in the investigators' judgement in consultation with the responsible physician or treating physician/specialist. In case of a contra-indication for MRI (e.g., a pacemaker), subjects will be excluded from this measurement but not necessarily from the study.
• Any medical condition or circumstance where supplementation with the nutritional supplement is potentially contra-indicated.
• Known allergy to any of the ingredients present in the nutritional supplement.
• Simultaneous use of other nutritional supplements during the study period (i.e., unwillingness to stop for the duration of the study).
• Current participation in other scientific research that conflicts with this study (e.g. intervention studies or weight management studies).
• No permission to request information from the general practitioner/treating specialist(s) about medical history, medication use.

• Pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Maastricht University Medical Center+ — Maastricht

Идентификаторы

NCT: NCT06771895 · METC 24-059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗