Clinical Trials Logo

Clinical Trial Summary

Intensive care unit (ICU)-acquired weakness (ICU-AW) is one of the most common complications of post-ICU syndrome. It is the leading cause of gait disturbance, decreased activities of daily living, and poor health-related quality of life. The early rehabilitation of critically ill patients can reduce the ICU-AW. We designed a protocol to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. The study is designed as a single-center, open-label, pilot, randomized, parallel-group study. After the screening, participants are randomly allocated to two groups, stratified by mechanical ventilation status. The intervention group will be provided with exercises of in-bed cycling/stepping according to the level of consciousness, motor power, and function in addition to conventional rehabilitation. In contrast, the control group will be provided with only conventional rehabilitation. The length of the intervention is from ICU admission to discharge, and interventions will be conducted for 20 minutes, a maximum of three times per session. The primary outcome is the number and percentage of completed in-bed cycling/stepping sessions, the duration and percentage of in-bed cycling/stepping sessions, and the number of cessations of in-bed cycling/stepping sessions. The secondary outcomes are the interval from ICU admission to the first session of in-bed cycling/stepping, the number and percentage of completed conventional rehabilitation sessions, the duration and percentage of conventional rehabilitation sessions, the number of cessations of conventional rehabilitation sessions, the number of adverse events, level of consciousness, functional mobility, muscle strength, activities of daily living, and quality of life. This study is a pilot clinical trial to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. If the expected results are achieved in this study, the methods of ICU rehabilitation will be enriched.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05868070
Study type Interventional
Source Seoul National University Hospital
Contact Woo Hyung Lee, MD, PhD
Phone 82-10-4640-6283
Email whlee909@snu.ac.kr
Status Recruiting
Phase N/A
Start date July 10, 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT05303623 - The Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients N/A
Recruiting NCT04541602 - Detection of Neuromuscular Complications in Critically Ill Patients
Completed NCT04589910 - Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound. N/A
Completed NCT05297188 - The Effect of Ergonomic Sleep Mask Usage on Patients' Sleep Quality and Comfort
Completed NCT04833621 - Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW? N/A
Active, not recruiting NCT03471247 - CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients N/A
Completed NCT05282576 - Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients N/A
Completed NCT04633421 - PRotEin Provision in Critical IllneSs N/A
Completed NCT02391103 - Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery N/A
Completed NCT04154995 - Intensive Care Unit Recovery
Not yet recruiting NCT06409611 - MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU N/A
Completed NCT06440265 - Validity and Reliability of Korean Version of AM-PAC Inpatient Short Form (Low Function) in Critically Ill Patients
Completed NCT02377830 - CYCLE Pilot Randomized Trial Phase 2
Completed NCT04435080 - Physical Rehabilitation in ICU in ARDS Patients With COVID-19
Terminated NCT04332263 - Neuromuscular Electrical Stimulation in ICU Patients N/A
Terminated NCT05474157 - Sarcopenia and Related Factors in Coronavirus Disease 2019 (COVID-19) Following Intensive Care
Not yet recruiting NCT06442254 - The Effects of Virtual Reality in Intensive Care Patients N/A
Completed NCT04459533 - Sparing in Neuromuscular Blockade in COVID 19 ICU
Completed NCT05591248 - Virtual Reality Rehabilitation on the Intensive Care Unit for Critically Ill Patients N/A