Post Intensive Care Optimization Through Lifestyle Intervention

Not Applicable

Not yet recruiting

• Conditions: ICU Survivor; Muscle Weakness

• Registration Number: NCT06771895
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Study Start: 2025-06-01
• Primary Completion: 2027-04-01
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Aerobic capacity	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by a VO2-peak test on ergometer
Muscle strength	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by 1-RM max testing
Muscle mass	At baseline (week 0) and at the end of the intervention (week 22)	as measured by whole-body MRI

Secondary Outcome Measures

Name	Time	Method
Gut health	In week 1, week 4 and week 21 of the intervention	by assessing intestinal microbiota composition, diversity and taxa abundance, functional capacity of the intestinal microbiota and metabolomics in feces samples
Muscle fiber size	At baseline (week 0) and at the end of the intervention (week 22)	as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)
Myonuclei quantity	At baseline (week 0) and at the end of the intervention (week 22)	as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)
Proportion (%) of muscle fiber types (type I and type II)	At baseline (week 0) and at the end of the intervention (week 22)	as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)
Frailty	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by the Clinical Frailty Scale
Quality of Life	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by the Short Form 36 Health Survey v2 and EuroQol-5 Dimensions-5 Levels questionnaires
Mental health	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by the Hospital Anxiety \& Depression Scale
Sleep quality	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by the Pittsburgh Sleep Quality Index
Supplement tolerance	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by the Gastrointestinal Symptom Rating Scale
Intestinal transit rate	In week 1, week 4 and week 21 of the intervention	as measured by the Bristol Stool Scale
Body fat composition	At baseline (week 0) and at the end of the intervention (week 22)	as measured by whole-body MRI
Body lean mass composition	At baseline (week 0) and at the end of the intervention (week 22)	as measured by whole-body MRI
Metabolic health	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	by assessing nutritional status, lipid profile, inflammatory profile, fasting glucose and insulin in plasma and serum samples
Brain health (cognitive function)	At baseline (week 0) and at the end of the intervention (week 22)	as measured by the Cambridge Neuropsychological Test Automated Battery
Step count	In week 1, week 11 and week 21 of the intervention	as measured by accelerometry
Age	At baseline (week 0)	as measured using a questionnaire
Body mass	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by a scale
Height	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by a stadiometer
Body Mass Index	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as calculated from height and body mass
Waist circumference	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by measuring tape
Systolic and diastolic blood pressure	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured using an automated device
Handgrip strength	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by a dynamometer
Functional capacity	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by the 6-Minute Walk Test
Physical function	At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)	as measured by the Short Physical Performance Battery
Dietary protein intake	In week 1, week 4 and week 21 of the intervention	as measured by dietary diaries
Dietary carbohydrate intake	In week 1, week 4 and week 21 of the intervention	as measured by dietary diaries
Dietary fat intake	In week 1, week 4 and week 21 of the intervention	as measured by dietary diaries

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Limburg, Netherlands