Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients

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.

Conditions

• Critically Ill Patient
• Intensive Care Unit Acquired Weakness

Interventions

DEVICE

Conventional rehabilitation plus multimodal exercise

Depending on the patient's condition, the intervention gradually progressed to passive, active assistive, active, and resistive exercise modes and the frequency of exercise interventions is gradually increased, and the application time of cycling/stepping is 20 minutes per session, and up to 3 times if there is no serious problem corresponding to the safety standards.

Sponsors & Collaborators

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Woo Hyung Lee, MD, PhD · Seoul National University Hospital

• Soohyun Wi Wi, PhD · Seoul National University Hospital

• Hyung-Ik Shin, MD, PhD · Seoul National University Hospital

• Sung Eun Hyun, MD, PhD · Seoul National University Hospital

• Kwan-Sik Sung, MS · Seoul National University Hospital

• Jeong Min Kim, MD · Seoul National University Hospital

• Yae Lim Lee, MD · Seoul National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-10

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• South Korea

Study Locations