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| Name | Class |
|---|---|
| Danone Global Research & Innovation Center | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined exercise and nutritional intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic capacity | as measured by a VO2-peak test on ergometer | 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 | At baseline (week 0), midline (week 11) and at the end of the intervention (week 22) |
| Muscle mass | as measured by whole-body MRI | At baseline (week 0) and at the end of the intervention (week 22) |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat composition | as measured by whole-body MRI | At baseline (week 0) and at the end of the intervention (week 22) |
| Body lean mass composition | as measured by whole-body MRI |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bram AJM Sauvé | Contact | +31433885836 | bram.sauve@maastrichtuniversity.nl | |
| Lex B Verdijk, Dr. | Contact | +31433881318 | lex.verdijk@maastrichtuniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| Lex B Verdijk, Dr. | Maastricht University | Principal Investigator |
| Luc JC van Loon, Prof. Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center+ | Maastricht | Limburg | 6229ER | Netherlands |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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This study can be defined as a single-group (uncontrolled) clinical trial.
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| 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 | 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 | In week 1, week 4 and week 21 of the intervention |
| Brain health (cognitive function) | as measured by the Cambridge Neuropsychological Test Automated Battery | At baseline (week 0) and at the end of the intervention (week 22) |
| Step count | as measured by accelerometry | In week 1, week 11 and week 21 of the intervention |
| Age | as measured using a questionnaire | At baseline (week 0) |
| Body mass | as measured by a scale | At baseline (week 0), midline (week 11) and at the end of the intervention (week 22) |
| Height | as measured by a stadiometer | 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 | At baseline (week 0), midline (week 11) and at the end of the intervention (week 22) |
| Waist circumference | as measured by measuring tape | 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 | At baseline (week 0), midline (week 11) and at the end of the intervention (week 22) |
| Handgrip strength | as measured by a dynamometer | 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 | 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 | 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) | 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) | 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) | At baseline (week 0) and at the end of the intervention (week 22) |
| Frailty | as measured by the Clinical Frailty Scale | 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 | 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 | 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 | 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 | 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 | In week 1, week 4 and week 21 of the intervention |
| Dietary protein intake | as measured by dietary diaries | In week 1, week 4 and week 21 of the intervention |
| Dietary carbohydrate intake | as measured by dietary diaries | In week 1, week 4 and week 21 of the intervention |
| Dietary fat intake | as measured by dietary diaries | In week 1, week 4 and week 21 of the intervention |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |