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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility and Safety of Digital Rehab Platform for Bedridden Patients

NCT06849765

ICU Acquired Weakness (ICUAW)

RECRUITING NA

Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

NCT02920684

Critically Ill Patients Under Mechanical Ventilation Sedated Patients

COMPLETED PHASE3

Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU

NCT02185989

ICU-acquired Muscle Weakness

COMPLETED NA

Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients

NCT06653998

Intensive Care Unit Acquired Weakness Intensive Care Unit Patients

RECRUITING

Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy

NCT02301273

Critical Illness

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critically Ill Patient Intensive Care Unit Acquired Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The group allocation will be performed by an independent researcher who is not involved in the evaluation of treatment outcomes and be concealed to physiotherapists who are involved in the evaluation of treatment outcomes. The participants and in-bed cycling/stepping intervention provider will be instructed not to disclose the allocation to the evaluator.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional rehabilitation

Conventional rehabilitation corresponds to general rehabilitation for critically ill patients and is mainly performed according to functional mobility with a range of motion. This includes Lying without contractures, turning self, sitting balance, sitting at the edge, standing and transfer, assisted gait, and gait endurance.

Group Type NO_INTERVENTION

No interventions assigned to this group

Conventional rehabilitation plus multimodal exercise

Conventional rehabilitation corresponds to general rehabilitation for critically ill patients and is mainly performed according to functional mobility with a range of motion. This includes Lying without contractures, turning self, sitting balance, sitting at the edge, standing and transfer, assisted gait, and gait endurance. Patients in the intervention group additionally receive multimodal exercise using the in-bed cycle/stepper.

Group Type EXPERIMENTAL

Conventional rehabilitation plus multimodal exercise

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 45
* Admission to ICU ≤ 72 hours
* Patient deemed to need ≥ 48 hours of ICU care
* Premorbid functional ambulation category≥ 2

Exclusion Criteria

* Neurologic disorders i.Central nervous system: acute stroke, advanced dementia, hypoxic-ischemic encephalopathy ii. Peripheral nervous system: amyotrophic lateral sclerosis, myasthenia gravis, acute inflammatory demyelinating polyneuropathy
* Acute deep venous thrombosis, pulmonary embolism
* Pneumothorax
* External fixator, superficial metallic implants, amputation, eschar, etc
* Expected ICU discharge within 3 days of admission
* Pregnant
* Difficulty in obtaining consent (rejection, no family, if the family does not agree)
* If the life expectancy is less than 6 months

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Woo Hyung Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR