Post Intensive Care Optimization Through Lifestyle Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined exercise and nutritional intervention.
- Who it may be relevant to
- Registry conditions: ICU Survivor, Muscle Weakness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 in
Primary outcome measures
- Aerobic capacity [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
- Muscle strength [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
- Muscle mass [Time frame: At baseline (week 0) and at the end of the intervention (week 22)]
Secondary outcome measures (12)
- Body fat composition [Time frame: At baseline (week 0) and at the end of the intervention (week 22)]
- Body lean mass composition [Time frame: At baseline (week 0) and at the end of the intervention (week 22)]
- Metabolic health [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
- Gut health [Time frame: In week 1, week 4 and week 21 of the intervention]
- Brain health (cognitive function) [Time frame: At baseline (week 0) and at the end of the intervention (week 22)]
- Step count [Time frame: In week 1, week 11 and week 21 of the intervention]
- Age [Time frame: At baseline (week 0)]
- Body mass [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
- Height [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
- Body Mass Index [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
- Waist circumference [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
- Systolic and diastolic blood pressure [Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Maastricht University Medical Center+ — Maastricht
Identifiers
NCT: NCT06771895 · METC 24-059