Clinical trial NCT05868070: Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients
Official title: Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients: A Study Protocol for a Pilot Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critically Ill Patient
Intensive Care Unit Acquired Weakness
Keywords: clinical trial
critically ill patient
in-bed cycling
in-bed stepping
intensive care unit
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: the number and percentage of completed in-bed cycling/stepping sessions
timeFrame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
measure: the duration and percentage of in-bed cycling/stepping sessions
timeFrame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
measure: the number of cessations of in-bed cycling/stepping sessions
timeFrame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
Secondary outcomes:
measure: the interval from ICU admission to the first session of in-bed cycling/stepping
timeFrame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
measure: the number and percentage of completed conventional rehabilitation sessions
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: the duration and percentage of conventional rehabilitation sessions
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: the number of cessations of conventional rehabilitation sessions
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: the number of adverse events
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: the confusion assessment method for the ICU (CAM-ICU)
timeFrame: baseline-ICU discharge (an average of 3 weeks)
measure: Richmond agitation-sedation scale (RASS)
timeFrame: baseline-ICU discharge (an average of 3 weeks)
measure: Functional ambulation category (FAC)
timeFrame: baseline
measure: Functional status score (FSS-ICU)
timeFrame: baseline-ICU discharge (an average of 3 weeks)
measure: Short physical performance battery score (SPPB)
timeFrame: 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)
measure: de Morton Mobility Index (DEMMI)
timeFrame: 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)
measure: Falls efficacy scale (FES)
timeFrame: 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)
measure: Activities-specific balance confidence scale (ABC)
timeFrame: 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)
measure: Sum of medical research council (MRC)
timeFrame: 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)
measure: Hand grip strength (HGS)
timeFrame: 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)
measure: Modified barthel index (MBI)
timeFrame: 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)
measure: 36-Item Short Form Survey (SF-36) version 2.0.
timeFrame: 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)
measure: days to initiate ambulation (FAC ≥2)
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: mortality-28 days
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: duration of mechanical ventilation
timeFrame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
measure: length of stay in the ICU
timeFrame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
measure: length of stay in the hospital
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: Pittsburgh rehabilitation participation scale (PRPS)
timeFrame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
measure: concomitant occupational therapy and its application dose
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
measure: concomitant pulmonary rehabilitation and its application dose
timeFrame: at every intervention (from baseline to hospital discharge, an average of 2 months)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Woo Hyung Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Soohyun Wi Wi, PhD
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Hyung-Ik Shin, MD, PhD
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Sung Eun Hyun, MD, PhD
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Kwan-Sik Sung, MS
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Jeong Min Kim, MD
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Yae Lim Lee, MD
role: STUDY_DIRECTOR
References: