Post Intensive Care Optimization Through Lifestyle Intervention

NCT06771895 | Not Yet Recruiting DMC

• 1 other identifier: METC 24-059
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU Survivor; Muscle Weakness

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (27)

• Body fat composition

  At baseline (week 0) and at the end of the intervention (week 22)

• Body lean mass composition

  At baseline (week 0) and at the end of the intervention (week 22)

• Metabolic health

  At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)

• Gut health

  In week 1, week 4 and week 21 of the intervention

• Brain health (cognitive function)

  At baseline (week 0) and at the end of the intervention (week 22)

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: Combined exercise and nutritional intervention

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Lex B Verdijk, Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Luc JC van Loon, Prof. Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bram AJM Sauvé

CONTACT

+31433885836; bram.sauve@maastrichtuniversity.nl

Lex B Verdijk, Dr.

CONTACT

+31433881318; lex.verdijk@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study can be defined as a single-group (uncontrolled) clinical trial.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

NL (1)