Clinical trial NCT06771895: Post Intensive Care Optimization Through Lifestyle Intervention
Official title: Post Intensive Care Optimization Through Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ICU Survivor
Muscle Weakness
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2025-01-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study can be defined as a single-group (uncontrolled) clinical trial.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Aerobic capacity
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Muscle strength
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Muscle mass
timeFrame: At baseline (week 0) and at the end of the intervention (week 22)
Secondary outcomes:
measure: Body fat composition
timeFrame: At baseline (week 0) and at the end of the intervention (week 22)
measure: Body lean mass composition
timeFrame: At baseline (week 0) and at the end of the intervention (week 22)
measure: Metabolic health
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Gut health
timeFrame: In week 1, week 4 and week 21 of the intervention
measure: Brain health (cognitive function)
timeFrame: At baseline (week 0) and at the end of the intervention (week 22)
measure: Step count
timeFrame: In week 1, week 11 and week 21 of the intervention
measure: Age
timeFrame: At baseline (week 0)
measure: Body mass
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Height
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Body Mass Index
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Waist circumference
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Systolic and diastolic blood pressure
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Handgrip strength
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Functional capacity
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Physical function
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Muscle fiber size
timeFrame: At baseline (week 0) and at the end of the intervention (week 22)
measure: Myonuclei quantity
timeFrame: At baseline (week 0) and at the end of the intervention (week 22)
measure: Proportion (%) of muscle fiber types (type I and type II)
timeFrame: At baseline (week 0) and at the end of the intervention (week 22)
measure: Frailty
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Quality of Life
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Mental health
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Sleep quality
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Supplement tolerance
timeFrame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
measure: Intestinal transit rate
timeFrame: In week 1, week 4 and week 21 of the intervention
measure: Dietary protein intake
timeFrame: In week 1, week 4 and week 21 of the intervention
measure: Dietary carbohydrate intake
timeFrame: In week 1, week 4 and week 21 of the intervention
measure: Dietary fat intake
timeFrame: In week 1, week 4 and week 21 of the intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
Study officials:
affiliation: Maastricht University
name: Lex B Verdijk, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Luc JC van Loon, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: