Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cohort Studies, ICU Acquired Weakness (ICUAW), Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analysis of Data and Development of Physical Function Assessment Indicators for Early Diagnosis and Monitoring Factors of Acquired Weakness in the Intensive Care Unit
Overview
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.
Primary outcome measures
- MRC sum [Time frame: Within 72 hours of ICU admission]
- Grip strength [Time frame: Within 72 hours of ICU admission]
- FSS-ICU [Time frame: Within 72 hours of ICU admission]
- JH-highest mobility scale [Time frame: Within 72 hours of ICU admission]
- Body composition [Time frame: Within 72 hours of ICU admission]
- US ( muscle thickness) [Time frame: Within 72 hours of ICU admission]
- Fitbit charge 5 [Time frame: During ICU status]
- Nerve conduction study [Time frame: Within 72 hours of ICU admission]
- Clinical Characteristics [Time frame: Within 72 hours of ICU admission]
Secondary outcome measures (7)
- MRC sum [Time frame: Within 24 hours of ICU discharge]
- Grip strength [Time frame: Within 24 hours of ICU admission]
- FSS-ICU [Time frame: Within 24 hours of ICU discharge]
- JH-highest mobility scale [Time frame: Within 24 hours of ICU discharge]
- Fitbit charge 5 [Time frame: Within 24 hours of ICU discharge]
- US -muscle thickness (T2) [Time frame: Within 24 hours of ICU discharge]
- Body composition(T2) [Time frame: Within 24 hours of ICU discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT06669494 · 2024-06-107