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

NCT05868070 | Unknown DMC

• 2 other identifiers: 0720234107202013C18
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

clinical trial; critically ill patient; in-bed cycling; in-bed stepping; intensive care unit

Outcome Measures

Primary Outcomes (3)

• the number and percentage of completed in-bed cycling/stepping sessions

  the number and percentage of completed in-bed cycling/stepping sessions

  at every intervention (from baseline to ICU discharge, an average of 3 weeks)

• the duration and percentage of in-bed cycling/stepping sessions

  the duration and percentage of in-bed cycling/stepping sessions

  at every intervention (from baseline to ICU discharge, an average of 3 weeks)

• the number of cessations of in-bed cycling/stepping sessions

  the number of cessations of in-bed cycling/stepping sessions

  at every intervention (from baseline to ICU discharge, an average of 3 weeks)

Secondary Outcomes (25)

• the interval from ICU admission to the first session of in-bed cycling/stepping

  at every intervention (from baseline to ICU discharge, an average of 3 weeks)

• the number and percentage of completed conventional rehabilitation sessions

  at every intervention (from baseline to hospital discharge, an average of 2 months)

• the duration and percentage of conventional rehabilitation sessions

  at every intervention (from baseline to hospital discharge, an average of 2 months)

• the number of cessations of conventional rehabilitation sessions

  at every intervention (from baseline to hospital discharge, an average of 2 months)

• the number of adverse events

  at every intervention (from baseline to hospital discharge, an average of 2 months)

Study Arms (2)

Conventional rehabilitation

NO INTERVENTION

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.

Conventional rehabilitation plus multimodal exercise

EXPERIMENTAL

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.

Device: Conventional rehabilitation plus multimodal exercise

Interventions

Conventional rehabilitation plus multimodal exercise 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.

Conventional rehabilitation plus multimodal exercise

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Related Publications (1)

• Wi S, Shin HI, Hyun SE, Sung KS, Lee WH. Feasibility and safety of in-bed cycling/stepping in critically ill patients: A study protocol for a pilot randomized controlled clinical trial. PLoS One. 2024 May 10;19(5):e0301368. doi: 10.1371/journal.pone.0301368. eCollection 2024.

  PMID: 38728323 DERIVED

Study Officials

• Woo Hyung Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Soohyun Wi Wi, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

• Hyung-Ik Shin, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

• Sung Eun Hyun, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

• Kwan-Sik Sung, MS

  Seoul National University Hospital

  STUDY DIRECTOR

• Jeong Min Kim, MD

  Seoul National University Hospital

  STUDY DIRECTOR

• Yae Lim Lee, MD

  Seoul National University Hospital

  STUDY DIRECTOR

Central Study Contacts

Woo Hyung Lee, MD, PhD

CONTACT

82-10-4640-6283; whlee909@snu.ac.kr

Soohyun Wi, PhD

CONTACT

82-10-8098-8022; wish.00118@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 22, 2023
• Study Start: July 10, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)