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

Analysis of Data and Development of Physical Function Assessment Indicators for Early Diagnosis and Monitoring Factors of Acquired Weakness in the Intensive Care Unit

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Critical Illness; Cohort Studies; ICU Acquired Weakness (ICUAW)

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 Type: Observational
• Enrollment (Estimated): 51

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to the MICU who are 19 years of age, SamsungMC

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Cohort; 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. This 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. -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. If the participant meets the criteria for sarcopenia based on bioelectrical impedance analysis (BIA), a nerve conduction study will be conducted

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
JH-highest mobility scale(T3)	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)	After 2 weeks of GW admission
MRC sum (T3)	Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness.	After 2 weeks of GW admission
Fitbit charge 5 (T3)	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.	After 2 weeks of GW admission
FSS-ICU(T3)	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.	After 2 weeks of GW admission
Grip strength(T3)	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.	After 2 weeks of GW admission

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Ministry of Health and Welfare

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Early mobilization; Post Intensive Care Syndrome(PICS); Intensive Care Unit acquired weakness; Digital Health Care Device
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Asthenia
• Other Study ID Numbers: 2024-06-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Registration number, age, gender, study measurements.
• IPD Sharing Time Frame: From October 1, 2025, to October 1, 2028.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No