Post Intensive Care Optimization Through Lifestyle Intervention (PICOLI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Muscle Weakness; ICU Survivor
• Intervention / Treatment: Behavioral: Combined exercise and nutritional intervention

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram AJM Sauvé; Phone Number: +31433885836; Email: bram.sauve@maastrichtuniversity.nl
• Study Contact Backup: Name: Lex B Verdijk, Dr.; Phone Number: +31433881318; Email: lex.verdijk@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229ER
      • Maastricht University Medical Center+
      • Contact: Lex B Verdijk, Dr.; Phone Number: +31433881318; Email: lex.verdijk@maastrichtuniversity.nl
      • Sub-Investigator: Bram AJM Sauvé, MSc
      • Principal Investigator: Lex B Verdijk, Dr.
      • Principal Investigator: Luc JC van Loon, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	as measured using a questionnaire	At baseline (week 0)
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	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
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Danone Global Research & Innovation Center
• Investigators: Principal Investigator: Luc JC van Loon, Prof. Dr., Maastricht University; Principal Investigator: Lex B Verdijk, Dr., Maastricht University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Muscle Weakness
• Other Study ID Numbers: METC 24-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No