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

Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients: A Study Protocol for a Pilot Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit Acquired Weakness; Critically Ill Patient
• Intervention / Treatment: Device: Conventional rehabilitation plus multimodal exercise

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Woo Hyung Lee, MD, PhD; Phone Number: 82-10-4640-6283; Email: whlee909@snu.ac.kr
• Study Contact Backup: Name: Soohyun Wi, PhD; Phone Number: 82-10-8098-8022; Email: wish.00118@gmail.com

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Soohyun Wi, Ph.D; Phone Number: 821080988022; Email: wish.00118@gmail.com
      • Contact: Woo Hyung Lee, MD, Ph.D; Phone Number: 821046406283; Email: whlee909@snu.ac.kr
      • Principal Investigator: Woo Hyung Lee
      • Sub-Investigator: Soo Hyun Wi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status score (FSS-ICU)	a 5-item to measure physical function for patients in ICU and consists of 5 categories: rolling, supine-to-sit transfers, unsupported sitting, sit-to-stand transfers, and ambulation. Each category was rated from 0 to 7, with a maximum cumulative score of 35.	baseline-ICU discharge (an average of 3 weeks)
Short physical performance battery score (SPPB)	SPPB is a common well-established measurement of physical performance and involves a timed 4-m walk, timed repeated chair sit-to-stand test, and 10-s balance tests including side-by-side, semi-tandem, and full-tandem. Each of the three subtests of the SPPB is scored from 0 to 4, and summed for a total score ranging from 0 to 12.	ICU discharge (an average of 3 weeks)-hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)-3 months after the hospital discharge (an average of 5 months)
Falls efficacy scale (FES)	The FES is a questionnaire that evaluates the fear of falls in daily life at home and is a 16 item questionnaire with a score ranging from minimum 16 to maximum 64.	hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)-3 months after the hospital discharge (an average of 5 months)
Activities-specific balance confidence scale (ABC)	ABC scale is a valid and reliable instrument to self-reporting measure of evaluates the fear of falling not only inside the house but also outside the house .	hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)-3 months after the hospital discharge (an average of 5 months)
Sum of medical research council (MRC)	MRC-sum score is a commonly used for evaluating the strength of the upper and lower extremities from grade 5 to 0. The sum of MRC scores will be evaluated the strength of a total of 12 joints of 6 joints including the arms, elbow, wrist, hip, knee, and ankle on both sides is measured, for a total of 60 points.	baseline-ICU discharge (an average of 3 weeks)-hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)
Hand grip strength (HGS)	HGS is commonly performed to measure hand muscle power using a dynamometer and provide an objective index of the functional integrity of the upper extremity.	baseline-ICU discharge (an average of 3 weeks)-hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)
Richmond agitation-sedation scale (RASS)	RASS is a valid and reliable assessment tool to measure the level of alertness and agitated behaviour in critically-ill patients.	baseline-ICU discharge (an average of 3 weeks)
Modified barthel index (MBI)	The MBI is a measure of activities of daily living and involves 10 domains of activities including bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.	ICU discharge (an average of 3 weeks)-hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)
36-Item Short Form Survey (SF-36) version 2.0.	SF-36 is a well-researched, self-reported measure of functional health. Each item consists of physical functioning, role limitations physical, bodily pain, general medical health, vitality, social functioning, role limitations emotional, mental health, physical component scale, and mental component scale.	hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)-3 months after the hospital discharge (an average of 5 months)
Functional ambulation category (FAC)	FAC is a 6-point functional gait test that assesses walking ability to determine how much support a patient needs when walking, with or without a personal assistive device. Nonfunctional gait is scored as 0, level 2 dependent gait is scored as 1, Level 1 dependent gait is scored as 2, supervised independent gait is scored as 3, independent gait on a flat surface is scored as 4, and independent gait anywhere is scored as 5.	baseline
duration of mechanical ventilation	duration of mechanical ventilation	at every intervention (from baseline to ICU discharge, an average of 3 weeks)
length of stay in the hospital	length of stay in the hospital	at every intervention (from baseline to hospital discharge, an average of 2 months)
the interval from ICU admission to the first session of in-bed cycling/stepping	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	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	a 5-item to measure physical function for patients in ICU and consists of 5 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	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	the number of adverse events	at every intervention (from baseline to hospital discharge, an average of 2 months)
the confusion assessment method for the ICU (CAM-ICU)	The CAM-ICU is a short test for the diagnosis of delirium in adult patients in critical care settings. As a tool to evaluate the presence of delirium, it is evaluated by four characteristics. Trait 1 is characterized by acute changes in mental state or fluctuating mental state, trait 2 is characterized by attention deficit, trait 3 is characterized by unsystematic thinking, and trait 4 is characterized by changes in the level of consciousness. The presence of delirium is when the trait 1 and trait 2 are present, and trait 3 or trait 4 is present.	baseline-ICU discharge (an average of 3 weeks)
de Morton Mobility Index (DEMMI)	DEMMI is a 15 item measure of mobility. In bed, three items will be evaluated: bridge, roll onto side, and lying to sitting. In the chair, three items will be evaluated: sit unsupported in chair, sit to stand from chair, and sit to stand without using arms. In the static balance, four items will be evaluated: stand unsupported, stand feet together, stand on toes, and tandem stand with eyes closed. And walking will be evaluated two items: walking distance and walking independence. In the dynamic balance, three items are evaluated pick up pen from floor, walks 4 steps backwards, jump. The DEMMI is considered an important characteristic of independent mobility and includes items that have validity in measuring the mobility domain defined by the World Health Organization. Using a simple conversion table for 15 evaluation items, it can convert ordinal mobility score (out of 19) into interval mobility score (out of 100).	baseline-ICU discharge (an average of 3 weeks)-hospital discharge (an average of 2 months)-1 month after the hospital discharge (an average of 3 months)
days to initiate ambulation (FAC ≥2)	days to initiate ambulation (FAC ≥2)	at every intervention (from baseline to hospital discharge, an average of 2 months)
mortality-28 days	mortality-28 days	at every intervention (from baseline to hospital discharge, an average of 2 months)
length of stay in the ICU	length of stay in the ICU	at every intervention (from baseline to ICU discharge, an average of 3 weeks)
Pittsburgh rehabilitation participation scale (PRPS)	PRPS is a clinician-rated instrument designed to assess a patient's participation in therapy. It is evaluated on a scale of 1 to 6 as an evaluation of the patient's effort and activeness participating in treatment.	at every intervention (from baseline to ICU discharge, an average of 3 weeks)
concomitant occupational therapy and its application dose	concomitant occupational therapy and its application dose	at every intervention (from baseline to hospital discharge, an average of 2 months)
concomitant pulmonary rehabilitation and its application dose	concomitant pulmonary rehabilitation and its application dose.	at every intervention (from baseline to hospital discharge, an average of 2 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional ambulation category (FAC)	FAC is a 6-point functional gait test that assesses walking ability to determine how much support a patient needs when walking, with or without a personal assistive device. Nonfunctional gait is scored as 0, level 2 dependent gait is scored as 1, Level 1 dependent gait is scored as 2, supervised independent gait is scored as 3, independent gait on a flat surface is scored as 4, and independent gait anywhere is scored as 5.	baseline
Pittsburgh rehabilitation participation scale (PRPS)	PRPS is a clinician-rated instrument designed to assess a patient's participation in therapy. It is evaluated on a scale of 1 to 6 as an evaluation of the patient's effort and activeness participating in treatment.	at every intervention (from baseline to hospital discharge, an average of 2 months)
the number of adverse events and rehabilitation stops	the number of adverse events and rehabilitation stops	at every intervention (from baseline to hospital discharge, an average of 2 months)
moltality	moltality	at every intervention (from baseline to hospital discharge, an average of 2 months)
duration of mechanical ventilation	duration of mechanical ventilation	at every intervention (from baseline to ICU discharge, an average of 3 weeks)
length of stay in ICU	length of stay in ICU	at every intervention (from baseline to ICU discharge, an average of 3 weeks)
length of stay in the hospital	length of stay in the hospital	at every intervention (from baseline to hospital discharge, an average of 2 months)
the presence of respiratory rehabilitation and application dose	the presence of respiratory rehabilitation and application dose	at every intervention (from baseline to hospital discharge, an average of 2 months)
the presence of occupational therapy and application dose	the presence of occupational therapy and application dose	at every intervention (from baseline to hospital discharge, an average of 2 months)
the number of conventional rehabilitation	the number of conventional rehabilitation	at every intervention (from baseline to hospital discharge, an average of 2 months)
the number of multimodal exercise intervention	the number of multimodal exercise intervention	at every intervention (from baseline to ICU discharge, an average of 3 weeks)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Woo Hyung Lee, MD, PhD, Seoul National University Hospital; Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: intensive care unit; clinical trial; critically ill patient; in-bed cycling; in-bed stepping
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 0720234107; 202013C18 (Other Grant/Funding Number: the Korea Medical Device Development Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No