Post Intensive Care Optimization Through Lifestyle Intervention (PICOLI)

May 2, 2025 updated by: Maastricht University Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University Medical Center+
        • Contact:
        • Sub-Investigator:
          • Bram AJM Sauvé, MSc
        • Principal Investigator:
          • Lex B Verdijk, Dr.
        • Principal Investigator:
          • Luc JC van Loon, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aerobic capacity
Time Frame: 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
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)
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
Time Frame: At baseline (week 0) and at the end of the intervention (week 22)
as measured by whole-body MRI
At baseline (week 0) and at the end of the intervention (week 22)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: At baseline (week 0)
as measured using a questionnaire
At baseline (week 0)
Body fat composition
Time Frame: At baseline (week 0) and at the end of the intervention (week 22)
as measured by whole-body MRI
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)
as measured by whole-body MRI
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)
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
Time Frame: 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
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)
as measured by the Cambridge Neuropsychological Test Automated Battery
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
as measured by accelerometry
In week 1, week 11 and week 21 of the intervention
Body mass
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by a scale
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)
as measured by a stadiometer
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)
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
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
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
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured using an automated device
At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Handgrip strength
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by a dynamometer
At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Functional capacity
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
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
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
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
Time Frame: 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)
At baseline (week 0) and at the end of the intervention (week 22)
Myonuclei quantity
Time Frame: 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)
At baseline (week 0) and at the end of the intervention (week 22)
Proportion (%) of muscle fiber types (type I and type II)
Time Frame: 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)
At baseline (week 0) and at the end of the intervention (week 22)
Frailty
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
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
Time Frame: 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
At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Mental health
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
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
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
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
Time Frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
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
Time Frame: In week 1, week 4 and week 21 of the intervention
as measured by the Bristol Stool Scale
In week 1, week 4 and week 21 of the intervention
Dietary protein intake
Time Frame: In week 1, week 4 and week 21 of the intervention
as measured by dietary diaries
In week 1, week 4 and week 21 of the intervention
Dietary carbohydrate intake
Time Frame: In week 1, week 4 and week 21 of the intervention
as measured by dietary diaries
In week 1, week 4 and week 21 of the intervention
Dietary fat intake
Time Frame: In week 1, week 4 and week 21 of the intervention
as measured by dietary diaries
In week 1, week 4 and week 21 of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danone Global Research & Innovation Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luc JC van Loon, Prof. Dr., Maastricht University
  • Principal Investigator: Lex B Verdijk, Dr., Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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