Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-30 @ 12:50 PM
Study NCT ID:
NCT06771895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2024-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Intensive Care Optimization Through Lifestyle Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study can be defined as a single-group (uncontrolled) clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aerobic capacity', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by a VO2-peak test on ergometer'}, {'measure': 'Muscle strength', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by 1-RM max testing'}, {'measure': 'Muscle mass', 'timeFrame': 'At baseline (week 0) and at the end of the intervention (week 22)', 'description': 'as measured by whole-body MRI'}], 'secondaryOutcomes': [{'measure': 'Body fat composition', 'timeFrame': 'At baseline (week 0) and at the end of the intervention (week 22)', 'description': 'as measured by whole-body MRI'}, {'measure': 'Body lean mass composition', 'timeFrame': 'At baseline (week 0) and at the end of the intervention (week 22)', 'description': 'as measured by whole-body MRI'}, {'measure': 'Metabolic health', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'by assessing nutritional status, lipid profile, inflammatory profile, fasting glucose and insulin in plasma and serum samples'}, {'measure': 'Gut health', 'timeFrame': 'In week 1, week 4 and week 21 of the intervention', 'description': 'by assessing intestinal microbiota composition, diversity and taxa abundance, functional capacity of the intestinal microbiota and metabolomics in feces samples'}, {'measure': 'Brain health (cognitive function)', 'timeFrame': 'At baseline (week 0) and at the end of the intervention (week 22)', 'description': 'as measured by the Cambridge Neuropsychological Test Automated Battery'}, {'measure': 'Step count', 'timeFrame': 'In week 1, week 11 and week 21 of the intervention', 'description': 'as measured by accelerometry'}, {'measure': 'Age', 'timeFrame': 'At baseline (week 0)', 'description': 'as measured using a questionnaire'}, {'measure': 'Body mass', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by a scale'}, {'measure': 'Height', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by a stadiometer'}, {'measure': 'Body Mass Index', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as calculated from height and body mass'}, {'measure': 'Waist circumference', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by measuring tape'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured using an automated device'}, {'measure': 'Handgrip strength', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by a dynamometer'}, {'measure': 'Functional capacity', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by the 6-Minute Walk Test'}, {'measure': 'Physical function', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by the Short Physical Performance Battery'}, {'measure': 'Muscle fiber size', 'timeFrame': 'At baseline (week 0) and at the end of the intervention (week 22)', 'description': 'as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)'}, {'measure': 'Myonuclei quantity', 'timeFrame': 'At baseline (week 0) and at the end of the intervention (week 22)', 'description': 'as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)'}, {'measure': 'Proportion (%) of muscle fiber types (type I and type II)', 'timeFrame': 'At baseline (week 0) and at the end of the intervention (week 22)', 'description': 'as determined by immunofluorescence staining of muscle biopsy of vastus lateralis (optional)'}, {'measure': 'Frailty', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by the Clinical Frailty Scale'}, {'measure': 'Quality of Life', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by the Short Form 36 Health Survey v2 and EuroQol-5 Dimensions-5 Levels questionnaires'}, {'measure': 'Mental health', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by the Hospital Anxiety \\& Depression Scale'}, {'measure': 'Sleep quality', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by the Pittsburgh Sleep Quality Index'}, {'measure': 'Supplement tolerance', 'timeFrame': 'At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)', 'description': 'as measured by the Gastrointestinal Symptom Rating Scale'}, {'measure': 'Intestinal transit rate', 'timeFrame': 'In week 1, week 4 and week 21 of the intervention', 'description': 'as measured by the Bristol Stool Scale'}, {'measure': 'Dietary protein intake', 'timeFrame': 'In week 1, week 4 and week 21 of the intervention', 'description': 'as measured by dietary diaries'}, {'measure': 'Dietary carbohydrate intake', 'timeFrame': 'In week 1, week 4 and week 21 of the intervention', 'description': 'as measured by dietary diaries'}, {'measure': 'Dietary fat intake', 'timeFrame': 'In week 1, week 4 and week 21 of the intervention', 'description': 'as measured by dietary diaries'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ICU Survivor', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 years and older\n* Minimum ICU length of stay of 5 days and/or mechanically ventilated for a minimum of 2 days\n* Persistent physical complaints\n* Community-dwelling, living independently (non-assisted)\n* Mentally competent with a Mini-Mental State Examination (MMSE) score of ≥24\n* Willing to participate in a 20-week multimodal lifestyle intervention\n\nExclusion Criteria:\n\n* 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.\n* Any medical condition or circumstance where supplementation with the nutritional supplement is potentially contra-indicated.\n* Known allergy to any of the ingredients present in the nutritional supplement.\n* Simultaneous use of other nutritional supplements during the study period (i.e., unwillingness to stop for the duration of the study).\n* Current participation in other scientific research that conflicts with this study (e.g. intervention studies or weight management studies).\n* No permission to request information from the general practitioner/treating specialist(s) about medical history, medication use.\n\n * Pregnancy."}, 'identificationModule': {'nctId': 'NCT06771895', 'acronym': 'PICOLI', 'briefTitle': 'Post Intensive Care Optimization Through Lifestyle Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Post Intensive Care Optimization Through Lifestyle Intervention', 'orgStudyIdInfo': {'id': 'METC 24-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: Combined exercise and nutritional intervention']}], 'interventions': [{'name': 'Combined exercise and nutritional intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'contacts': [{'name': 'Lex B Verdijk, Dr.', 'role': 'CONTACT', 'email': 'lex.verdijk@maastrichtuniversity.nl', 'phone': '+31433881318'}, {'name': 'Bram AJM Sauvé, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lex B Verdijk, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luc JC van Loon, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maastricht University Medical Center+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Bram AJM Sauvé', 'role': 'CONTACT', 'email': 'bram.sauve@maastrichtuniversity.nl', 'phone': '+31433885836'}, {'name': 'Lex B Verdijk, Dr.', 'role': 'CONTACT', 'email': 'lex.verdijk@maastrichtuniversity.nl', 'phone': '+31433881318'}], 'overallOfficials': [{'name': 'Lex B Verdijk, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}, {'name': 'Luc JC van Loon, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Not yet determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}