An interventional study of Combined exercise and nutritional intervention in ICU Survivor and Muscle Weakness, sponsored by Maastricht University Medical Center. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.
This study's planned enrollment of 35 is below the median of 44 across 362 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No permission to request information from the general practitioner/treating specialist(s) about medical history, medication use.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: 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 intake moment following each training session.
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)
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)
Muscle mass
as measured by whole-body MRI
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
Body fat composition
as measured by whole-body MRI
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
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)
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)
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 intervention
Brain health (cognitive function)
as measured by the Cambridge Neuropsychological Test Automated Battery
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
Step count
as measured by accelerometry
Time frame: In week 1, week 11 and week 21 of the intervention
Age
as measured using a questionnaire
Time frame: At baseline (week 0)
Body mass
as measured by a scale
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Height
as measured by a stadiometer
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Body Mass Index
as calculated from height and body mass
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Waist circumference
as measured by measuring tape
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Systolic and diastolic blood pressure
as measured using an automated device
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Handgrip strength
as measured by a dynamometer
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Functional capacity
as measured by the 6-Minute Walk Test
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Physical function
as measured by the Short Physical Performance Battery
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Muscle fiber size
as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
Myonuclei quantity
as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
Proportion (%) of muscle fiber types (type I and type II)
as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
Frailty
as measured by the Clinical Frailty Scale
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Quality of Life
as measured by the Short Form 36 Health Survey v2 and EuroQol-5 Dimensions-5 Levels questionnaires
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Mental health
as measured by the Hospital Anxiety \& Depression Scale
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Sleep quality
as measured by the Pittsburgh Sleep Quality Index
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Supplement tolerance
as measured by the Gastrointestinal Symptom Rating Scale
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Intestinal transit rate
as measured by the Bristol Stool Scale
Time frame: In week 1, week 4 and week 21 of the intervention
Dietary protein intake
as measured by dietary diaries
Time frame: In week 1, week 4 and week 21 of the intervention
Dietary carbohydrate intake
as measured by dietary diaries
Time frame: In week 1, week 4 and week 21 of the intervention
Dietary fat intake
as measured by dietary diaries
Time frame: In week 1, week 4 and week 21 of the intervention
Plan to share: Undecided — Not yet determined
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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