Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness

• Conditions: Cohort Studies; ICU Acquired Weakness (ICUAW); Critical Illness

• Registration Number: NCT06669494
• Lead Sponsor: Samsung Medical Center

Brief Summary

Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired weakness

Detailed Description

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.

Recent 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.

This study seeks to provide foundational data for developing personalized educational programs applicable to remote digital therapeutics in the future.

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-30
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Posted: 2024-11-01
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-10-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Patients admitted to the ICU who are 19 years of age
• Patients who did consent of the study

Exclusion Criteria

• Patients with a history of peripheral nerve injury
• Patients with a history of major surgery within the past 12 weeks or those expected to undergo major surgery during the trial period
• Patients with a history of central nervous system disorders (e.g., stroke, spinal cord injury)
• Patients with cognitive impairment that may interfere with the conduct of the study
• Patients with Do Not Resuscitate (DNR) orders, brain lesions, Clinical Frailty Score (CFS) exceeding 4, or those who have undergone cardiopulmonary resuscitation
• Patients confirmed to have metastatic cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRC sum	Within 72 hours of ICU admission	Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness.
Grip strength	Within 72 hours of ICU admission	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.
FSS-ICU	Within 72 hours of ICU admission	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.
JH-highest mobility scale	Within 72 hours of ICU admission	There are a total of 8 stages : lying 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)
Body composition	Within 72 hours of ICU admission	Height, weight, BMI, body fat percentage, Muscle mass are measured using an InBody device
US ( muscle thickness)	Within 72 hours of ICU admission	Muscle Thickness for a total of 6 tems in the upper and lower limbs, swallowing muscles , is measured using ultrasound examination
Fitbit charge 5	During ICU status	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.
Nerve conduction study	Within 72 hours of ICU admission	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
Clinical Characteristics	Within 72 hours of ICU admission	Age,Diagnosis,CCI,Medical History,Education Level,Marital status

Secondary Outcome Measures

Name	Time	Method
MRC sum	Within 24 hours of ICU discharge	Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness.
Grip strength	Within 24 hours of ICU admission	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.
FSS-ICU	Within 24 hours of ICU discharge	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.
JH-highest mobility scale	Within 24 hours of ICU discharge	There are a total of 8 stages : lying 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)
Fitbit charge 5	Within 24 hours of ICU discharge	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.
US -muscle thickness (T2)	Within 24 hours of ICU discharge	Muscle Thickness for a total of 6 tems in the upper and lower limbs, swallowing muscles , is measured using ultrasound examination
Body composition(T2)	Within 24 hours of ICU discharge	Height, weight, BMI, body fat percentage, Muscle mass are measured using an InBody device

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of