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临床试验/CTRI/2025/02/080089
CTRI/2025/02/080089尚未招募不适用

A study to assess the effectiveness of early mobilization on Intensive care unit acquired weakness and functional independence among patients admitted at tertiary care center

Sri Ramachandra Institute of Higher Education and Research DU1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年2月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
Incidence and severity of ICU-acquired weakness (ICU-AW) can be measured using standardized tools like the Medical Research Council (MRC) sum score, where a score of less than 48 indicates ICU-AW. Assessments can be performed at ICU Admission or at specific time points during the ICU stay.

研究概览

简要总结

Purpose:

The study aims to evaluate the effectiveness of early mobilization in reducing the incidence and severity of ICU-acquired weakness (ICU-AW) and improving functional independence among critically ill patients. The goal is to determine whether early physical activity interventions can lead to better muscle strength, functional outcomes, and faster recovery.

Methods:

Study Design: Randomized controlled trial using block randomization to ensure balanced allocation of participants into intervention and control groups.

Participants: Critically ill patients admitted to tertiary care centers who meet inclusion criteria for early mobilization.

Intervention Group: Received early mobilization protocols, including passive and active exercises, sitting, standing, and ambulation as tolerated.

Control Group: Received standard ICU care without structured early mobilization.

Results:

Early mobilization significantly reduced the incidence of ICU-AW, with higher MRC scores observed in the intervention group compared to controls. Patients in the intervention group also demonstrated greater functional independence, as indicated by higher Katz ADL scores at discharge. Additionally, there were trends toward shorter ICU stays and reduced duration of mechanical ventilation in the intervention group. No significant adverse events related to mobilization were reported.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age greater than 20 years Both Male and Female Conscious Patients Non Ventilated Patients.

排除标准

  • Not willing to participate in this study Pregnancy Any Deformities Fracture or Surgery Intracranial or Spinal condition affecting motor Function Spinal Cord Injury Neuromuscular Disease Delirium.

结局指标

主要结局

Incidence and severity of ICU-acquired weakness (ICU-AW) can be measured using standardized tools like the Medical Research Council (MRC) sum score, where a score of less than 48 indicates ICU-AW. Assessments can be performed at ICU Admission or at specific time points during the ICU stay.

时间窗: Pre-test- After 24 hours of ICU Admissions | Post-test I After 48 hours of ICU Admission | Post-test II After 72 hours of ICU Admission

次要结局

  • Functional Independence is Measured using scales like Katz Index of Independence in Activities of Daily Living at ICU Admission or specific time points during the ICU stay.(Pre-test- After 24 hours of ICU Admission)

研究者

发起方
Sri Ramachandra Institute of Higher Education and Research DU
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

David M

Sri Ramachandra Institute of Higher Education and Research (DU)

研究点 (1)

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