ICU SurvivorPICOLINCT06771895
Post Intensive Care Optimization Through Lifestyle Intervention
A study testing Combined exercise and nutritional intervention in people with ICU Survivor and Muscle Weakness, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Survivor, Muscle Weakness
- What is being tested?
- Combined exercise and nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
Lex B Verdijk, Dr., +31433881318, lex.verdijk@maastrichtuniversity.nl
Bram AJM Sauvé, MSc
About this study
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
- Being tested
- Combined exercise and nutritional intervention
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise and nutritional interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Combined exercise and nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
as measured by a VO2-peak test on ergometer
Measured: 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
Measured: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Muscle mass
as measured by whole-body MRI
Measured: At baseline (week 0) and at the end of the intervention (week 22)
Secondary outcomes (27)
Body fat composition
as measured by whole-body MRI
Measured: At baseline (week 0) and at the end of the intervention (week 22)
Body lean mass composition
as measured by whole-body MRI
Measured: 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
Measured: 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
Measured: In week 1, week 4 and week 21 of the intervention
Brain health (cognitive function)
as measured by the Cambridge Neuropsychological Test Automated Battery
Measured: At baseline (week 0) and at the end of the intervention (week 22)
Step count
as measured by accelerometry
Measured: In week 1, week 11 and week 21 of the intervention
Age
as measured using a questionnaire
Measured: At baseline (week 0)
Body mass
as measured by a scale
Measured: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Height
as measured by a stadiometer
Measured: 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
Measured: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Waist circumference
as measured by measuring tape
Measured: 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
Measured: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
Handgrip strength
as measured by a dynamometer
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At baseline (week 0) and at the end of the intervention (week 22)
Frailty
as measured by the Clinical Frailty Scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: In week 1, week 4 and week 21 of the intervention
Dietary protein intake
as measured by dietary diaries
Measured: In week 1, week 4 and week 21 of the intervention
Dietary carbohydrate intake
as measured by dietary diaries
Measured: In week 1, week 4 and week 21 of the intervention
Dietary fat intake
as measured by dietary diaries
Measured: In week 1, week 4 and week 21 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study can be defined as a single-group (uncontrolled) clinical trial.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Sponsor
- Investigators
- Lex B Verdijk, Dr., Principal investigator, Maastricht UniversityLuc JC van Loon, Prof. Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771895
- Sponsor's protocol ID
- METC 24-059
- Acronym
- PICOLI
- Status last verified
- May 2025
- First submitted
- 10 Dec 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet determined
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Intensive Care Optimization Through Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT06771895
- Acronym / sponsor ID
- PICOLI / METC 24-059
- Conditions
- ICU Survivor, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study can be defined as a single-group (uncontrolled) clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Combined exercise and nutritional intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined exercise and nutritional interventionThe 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. | Behavioural | Intervention |
Primary outcome
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
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
Muscle mass
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
as measured by whole-body MRI
27 secondary outcomes
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)
Handgrip strength
Time frame: 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)
Physical function
Time frame: 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)
Myonuclei quantity
Time frame: 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)
Frailty
Time frame: 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)
Mental health
Time frame: 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)
Supplement tolerance
Time frame: 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
Dietary protein intake
Time frame: 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
Dietary fat intake
Time frame: In week 1, week 4 and week 21 of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Undecided. Not yet determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lex B Verdijk, Dr. principal investigator
Maastricht University
Luc JC van Loon, Prof. Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise and nutritional intervention in people with ICU Survivor and Muscle Weakness, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bram AJM Sauvé (+31433885836, bram.sauve@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.