The Effect of In-bed Cycling/Stepping on Functional Mobility in Critically Ill Patients

Study Overview
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Brief Summary
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Intensive care unit (ICU)-acquired weakness is one of the most common complications of post-intensive care syndrome. It is the main cause of gait disturbance, decreased activity of daily living, and poor health-related quality of life that may occur and even persist after ICU discharge. Early rehabilitation of critically ill patients can reduce the incidence and severity of ICU-acquired weakness. We have designed a protocol to investigate that conventional rehabilitation plus in-bed cycling/stepping is more effective in restoring functional mobility compared to conventional rehabilitation alone in critically ill patients. This study protocol is a randomized controlled trial with an intervention time from ICU admission to discharge. After the screening, participants are randomly allocated to the intervention group or control group with stratification of the status of mechanical ventilation. The intervention group is provided with graded exercise using the in-bed cycle ergometer/stepper according to consciousness and motor power in addition to conventional rehabilitation whereas the control group is provided with only conventional rehabilitation. The primary outcome is functional mobility in terms of the de Morton Mobility Index at ICU discharge. The secondary outcomes are level of consciousness, mobility, muscle strength, the activity of daily living, and quality of life. All adverse events will be recorded from the beginning of each intervention session. This study is a clinical trial to estimate the effect of in-bed cycling/stepping on functional mobility in critically ill patients. If the expected results are achieved in this study, methods of ICU rehabilitation will be enriched.

Official Title
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The Effect of In-bed Cycling/Stepping on Functional Mobility in Critically Ill Patients: a Prospective, Single-center, Single-blind, Open-label, Exploratory Pilot Clinical Trial

Conditions
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Critically Ill Patient, Intensive Care Unit Acquired Weakness

Intervention / Treatment
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* Device: Conventional rehabilitation plus multimodal exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional rehabilitation<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | hospital discharge (an average of 2 months) | 

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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in-bed cycling, in-bed stepper, Multimodal exercise