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

NCT06669494 | Enrolling By Invitation

• 1 other identifier: 2024-06-107
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Post Intensive Care Syndrome(PICS); Intensive Care Unit acquired weakness; Early mobilization; Digital Health Care Device

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• MRC sum

  Within 24 hours of ICU discharge

• Grip strength

  Within 24 hours of ICU admission

• FSS-ICU

  Within 24 hours of ICU discharge

• JH-highest mobility scale

  Within 24 hours of ICU discharge

• Fitbit charge 5

  Within 24 hours of ICU discharge

Other Outcomes (5)

• JH-highest mobility scale(T3)

  After 2 weeks of GW admission

• MRC sum (T3)

  After 2 weeks of GW admission

• Fitbit charge 5 (T3)

  After 2 weeks of GW admission

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ministry of Health and Welfare: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD, Assistant professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: November 1, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From October 1, 2025, to October 1, 2028.

Locations

KR (1)