NCT Number: NCT06771895
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6229ER, Netherlands
Bram AJM Sauvé, MSc
SUB_INVESTIGATOR
Lex B Verdijk, Dr.
CONTACT
Lex B Verdijk, Dr.
PRINCIPAL_INVESTIGATOR
Luc JC van Loon, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
as measured by whole-body MRI
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
as measured by whole-body MRI
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
as measured by whole-body MRI
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
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
Time frame: At baseline (week 0) and at the end of the intervention (week 22)
as measured by the Cambridge Neuropsychological Test Automated Battery
Time frame: In week 1, week 11 and week 21 of the intervention
as measured by accelerometry
Time frame: At baseline (week 0)
as measured using a questionnaire
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by a scale
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by a stadiometer
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
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by measuring tape
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured using an automated device
Time frame: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by a dynamometer
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
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
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)
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)
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)
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
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
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
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
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
Time frame: In week 1, week 4 and week 21 of the intervention
as measured by the Bristol Stool Scale
Time frame: In week 1, week 4 and week 21 of the intervention
as measured by dietary diaries
Time frame: In week 1, week 4 and week 21 of the intervention
as measured by dietary diaries
Time frame: In week 1, week 4 and week 21 of the intervention
as measured by dietary diaries
Contact information is provided by the study sponsor or research team.
Bram AJM Sauvé
CONTACT
Lex B Verdijk, Dr.
CONTACT
Maastricht University Medical Center
Other
Acronym: PICOLI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04640441
ICU Survivor, Unable to Sit-to-stand
Taipei, National Taiwan University Hospital, Taiwan
View Trial DetailsNCT05766319
Critical Illness, Critically Ill
Leiden, South Holland, Netherlands
View Trial DetailsNCT07531498
Atrophy, Low Muscle Mass
Memphis, Tennessee, United States
View Trial DetailsNCT07435402
Burns - Multiple, Critical Illness
Prague, Česká Republika, Czechia
View Trial Details