Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06669494
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-19
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'C000657744', 'term': 'postintensive care syndrome'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'JH-highest mobility scale(T3)', 'timeFrame': 'After 2 weeks of GW admission', 'description': 'There are a total of 8 stages :\n\nlying in bed(1pt) Limited to activities in bed only(2 pt) Sitting up in bed (3 pt) Sitting on a chair beside the bed(4 pt) Standing(5 pt) Walking 10 steps beside the bed(6pt) Walking more than 7 meters (7pt) Walking more than 76 meters (8 pt)'}, {'measure': 'MRC sum (T3)', 'timeFrame': 'After 2 weeks of GW admission', 'description': 'Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness.'}, {'measure': 'Fitbit charge 5 (T3)', 'timeFrame': 'After 2 weeks of GW admission', 'description': 'Activity amount assessment The Fitbit Charge 5 is a wristband device equipped with an accelerometer that detects movement across three axes. It tracks information such as step count, distance traveled, calories burned, and active minutes, recording data from the time of wear until the battery depletes. This wearable device enables lifelogging through accelerometry. The Fitbit Charge 5 will be worn continuously from ICU admission upon study enrollment through to two weeks post-ICU discharge.'}, {'measure': 'FSS-ICU(T3)', 'timeFrame': 'After 2 weeks of GW admission', 'description': 'Functional status Score for the4 Intensive Care Unit 5 Functional movement : Rolling / Supine to Sit / Sit to Stand / Sitting on the edge of the bed, Walking Each item is scored from 0 to 7 based on the level of assistance needed, with 0 indicating complete inability and 35 indicating independent function.'}, {'measure': 'Grip strength(T3)', 'timeFrame': 'After 2 weeks of GW admission', 'description': 'To assess forearm strength, grip strength is measured using a dynamometer. Two measurements are taken on both the left and right sides, and the average value is recorded.'}], 'primaryOutcomes': [{'measure': 'MRC sum', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness.'}, {'measure': 'Grip strength', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'To assess forearm strength, grip strength is measured using a dynamometer. Two measurements are taken on both the left and right sides, and the average value is recorded.'}, {'measure': 'FSS-ICU', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'Functional status Score for the4 Intensive Care Unit 5 Functional movement : Rolling / Supine to Sit / Sit to Stand / Sitting on the edge of the bed, Walking Each item is scored from 0 to 7 based on the level of assistance needed, with 0 indicating complete inability and 35 indicating independent function.'}, {'measure': 'JH-highest mobility scale', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'There are a total of 8 stages :\n\nlying in bed(1pt) Limited to activities in bed only(2 pt) Sitting up in bed (3 pt) Sitting on a chair beside the bed(4 pt) Standing(5 pt) Walking 10 steps beside the bed(6pt) Walking more than 7 meters (7pt) Walking more than 76 meters (8 pt)'}, {'measure': 'Body composition', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'Height, weight, BMI, body fat percentage, Muscle mass are measured using an InBody device'}, {'measure': 'US ( muscle thickness)', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'Muscle Thickness for a total of 6 tems in the upper and lower limbs, swallowing muscles , is measured using ultrasound examination'}, {'measure': 'Fitbit charge 5', 'timeFrame': 'During ICU status', 'description': 'Activity amount assessment The Fitbit Charge 5 is a wristband device equipped with an accelerometer that detects movement across three axes. It tracks information such as step count, distance traveled, calories burned, and active minutes, recording data from the time of wear until the battery depletes. This wearable device enables lifelogging through accelerometry. The Fitbit Charge 5 will be worn continuously from ICU admission upon study enrollment through to two weeks post-ICU discharge.'}, {'measure': 'Nerve conduction study', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'IF Sarcopenia are met via Body Composition Assessment, nerve conduction study (NCS) is performed. NCS is conducted to evaluate peripheral nerve function and to determine the presence of peripheral neuropathy in this study. The nerve conduction study uses electrical stimulation to measure nerve conduction velocity, latency, and amplitude'}, {'measure': 'Clinical Characteristics', 'timeFrame': 'Within 72 hours of ICU admission', 'description': 'Age,Diagnosis,CCI,Medical History,Education Level,Marital status'}], 'secondaryOutcomes': [{'measure': 'MRC sum', 'timeFrame': 'Within 24 hours of ICU discharge', 'description': 'Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness.'}, {'measure': 'Grip strength', 'timeFrame': 'Within 24 hours of ICU admission', 'description': 'To assess forearm strength, grip strength is measured using a dynamometer. Two measurements are taken on both the left and right sides, and the average value is recorded.'}, {'measure': 'FSS-ICU', 'timeFrame': 'Within 24 hours of ICU discharge', 'description': 'Functional status Score for the4 Intensive Care Unit 5 Functional movement : Rolling / Supine to Sit / Sit to Stand / Sitting on the edge of the bed, Walking Each item is scored from 0 to 7 based on the level of assistance needed, with 0 indicating complete inability and 35 indicating independent function.'}, {'measure': 'JH-highest mobility scale', 'timeFrame': 'Within 24 hours of ICU discharge', 'description': 'There are a total of 8 stages :\n\nlying in bed(1pt) Limited to activities in bed only(2 pt) Sitting up in bed (3 pt) Sitting on a chair beside the bed(4 pt) Standing(5 pt) Walking 10 steps beside the bed(6pt) Walking more than 7 meters (7pt) Walking more than 76 meters (8 pt)'}, {'measure': 'Fitbit charge 5', 'timeFrame': 'Within 24 hours of ICU discharge', 'description': 'Activity amount assessment The Fitbit Charge 5 is a wristband device equipped with an accelerometer that detects movement across three axes. It tracks information such as step count, distance traveled, calories burned, and active minutes, recording data from the time of wear until the battery depletes. This wearable device enables lifelogging through accelerometry. The Fitbit Charge 5 will be worn continuously from ICU admission upon study enrollment through to two weeks post-ICU discharge.'}, {'measure': 'US -muscle thickness (T2)', 'timeFrame': 'Within 24 hours of ICU discharge', 'description': 'Muscle Thickness for a total of 6 tems in the upper and lower limbs, swallowing muscles , is measured using ultrasound examination'}, {'measure': 'Body composition(T2)', 'timeFrame': 'Within 24 hours of ICU discharge', 'description': 'Height, weight, BMI, body fat percentage, Muscle mass are measured using an InBody device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post Intensive Care Syndrome(PICS)', 'Intensive Care Unit acquired weakness', 'Early mobilization', 'Digital Health Care Device'], 'conditions': ['Cohort Studies', 'ICU Acquired Weakness (ICUAW)', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired weakness', 'detailedDescription': "ICU-acquired weakness (ICU-AW) is a prevalent complication, occurring in more than 50% of ICU patients, and has severe long-term effects on patient outcomes. This condition not only prolongs the duration of hospital stay but also persists long after discharge, continuously impacting patients' health and quality of life. Therefore, monitoring, prevention, and rehabilitation of ICU-AW should not be limited to the ICU period but should continue after transfer to general wards and after discharge. This study aims to provide foundational data for developing a platform capable of continuously monitoring and delivering rehabilitation therapy for ICU-AW from ICU admission through the post-discharge period.\n\nRecent meta-analyses have shown that providing rehabilitation for ICU patients improves physical function at discharge, reduces ICU stay by 0.8 days, and shortens total hospital stay by 1.75 days. Additionally, it increases the distance patients can walk unassisted at discharge, the number of patients capable of standing, the duration of ventilator-free days, and the percentage of patients discharged home. Understanding the recovery process of ICU-AW as a continuum from ICU to post-discharge is essential, and the necessity of continuous rehabilitation throughout this process is evident. However, the challenge lies in implementing this in real-world practice.\n\nThis study seeks to provide foundational data for developing personalized educational programs applicable to remote digital therapeutics in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the MICU who are 19 years of age, SamsungMC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the ICU who are 19 years of age\n* Patients who did consent of the study\n\nExclusion Criteria:\n\n* Patients with a history of peripheral nerve injury\n* Patients with a history of major surgery within the past 12 weeks or those expected to undergo major surgery during the trial period\n* Patients with a history of central nervous system disorders (e.g., stroke, spinal cord injury)\n* Patients with cognitive impairment that may interfere with the conduct of the study\n* Patients with Do Not Resuscitate (DNR) orders, brain lesions, Clinical Frailty Score (CFS) exceeding 4, or those who have undergone cardiopulmonary resuscitation\n* Patients confirmed to have metastatic cancer'}, 'identificationModule': {'nctId': 'NCT06669494', 'acronym': 'Beyond ICU', 'briefTitle': 'Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Analysis of Data and Development of Physical Function Assessment Indicators for Early Diagnosis and Monitoring Factors of Acquired Weakness in the Intensive Care Unit', 'orgStudyIdInfo': {'id': '2024-06-107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': "This exploratory study aims to investigate the relationship between activity levels/muscle mass and clinical indicators. ., assuming an estimated Spearman's rank correlation of 0.7, a sample size of 43 participants would yield a two-sided 95% confidence interval with a margin of error of 0.17. Considering a dropout rate of 15%, a total of 51 participants is required.\n\nThis study will begin enrolling ICU patients with weakness following approval from the Institutional Review Board (IRB). With an estimated enrollment rate of fewer than one participant per week, the enrollment period is expected to last approximately 12 months.\n\n-Lifelog via Wearable Device (Accelerometer::Fitbit) Participants will wear the Fitbit Charge 5 from the time of study registration after ICU admission until two weeks post-ICU discharge.\n\nIf the participant meets the criteria for sarcopenia based on bioelectrical impedance analysis (BIA), a nerve conduction study will be conducted"}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'From October 1, 2025, to October 1, 2028.', 'ipdSharing': 'YES', 'description': 'Registration number, age, gender, study measurements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health and Welfare', 'class': 'AMBIG'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, PhD, Assistant professor', 'investigatorFullName': 'Jong Geol Do', 'investigatorAffiliation': 'Samsung Medical Center'}}}}