Post Intensive Care Optimization Through Lifestyle Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Combined exercise and nutritional intervention
BehavioralThe 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 intake moment following each training session.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Aerobic capacity
as measured by a VO2-peak test on ergometer
Time frame
At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)2
Muscle strength
as measured by 1-RM max testing
Time frame
At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)3
Muscle mass
as measured by whole-body MRI
Time frame
At baseline (week 0) and at the end of the intervention (week 22)Secondary outcomes
1
Body fat composition
as measured by whole-body MRI
Time frame
At baseline (week 0) and at the end of the intervention (week 22)2
Body lean mass composition
as measured by whole-body MRI
Time frame
At baseline (week 0) and at the end of the intervention (week 22)3
Metabolic health
by assessing nutritional status, lipid profile, inflammatory profile, fasting glucose and insulin in plasma and serum samples
Time frame
At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)4
Gut health
by assessing intestinal microbiota composition, diversity and taxa abundance, functional capacity of the intestinal microbiota and metabolomics in feces samples
Time frame
In week 1, week 4 and week 21 of the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maastricht University Medical Center
Lead sponsor
Danone Global Research & Innovation Center
Collaborator
Source ClinicalTrials.gov
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