search
Back to results

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

Primary Purpose

Critically Ill Patient, Intensive Care Unit Acquired Weakness

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Conventional rehabilitation plus multimodal exercise
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Patient focused on measuring in-bed cycling, in-bed stepper, Multimodal exercise

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional rehabilitation

Conventional rehabilitation plus multimodal exercise

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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 .
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 2, 2023
Last Updated
July 23, 2023
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05868070
Brief Title
The Effect of In-bed Cycling/Stepping on Functional Mobility in Critically Ill Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patient, Intensive Care Unit Acquired Weakness
Keywords
in-bed cycling, in-bed stepper, Multimodal exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
An outcome assessor will be blinded after assignment to interventions by blocking access to the web randomization table operated on the website.
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional rehabilitation
Arm Type
No Intervention
Arm Description
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.
Arm Title
Conventional rehabilitation plus multimodal exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional rehabilitation plus multimodal exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
de Morton Mobility Index (DEMMI)
Description
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).
Time Frame
hospital discharge (an average of 2 months)
Secondary Outcome Measure Information:
Title
Functional status score (FSS-ICU)
Description
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.
Time Frame
baseline-ICU discharge (an average of 3 weeks)
Title
Short physical performance battery score (SPPB)
Description
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.
Time Frame
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)
Title
Falls efficacy scale (FES)
Description
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.
Time Frame
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)
Title
Activities-specific balance confidence scale (ABC)
Description
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 .
Time Frame
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)
Title
Sum of medical research council (MRC)
Description
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.
Time Frame
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)
Title
Hand grip strength (HGS)
Description
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.
Time Frame
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)
Title
Confusion assessment method for the ICU (CAM-ICU)
Description
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.
Time Frame
baseline-ICU discharge (an average of 3 weeks)
Title
Richmond agitation-sedation scale (RASS)
Description
RASS is a valid and reliable assessment tool to measure the level of alertness and agitated behaviour in critically-ill patients.
Time Frame
baseline-ICU discharge (an average of 3 weeks)
Title
Modified barthel index (MBI)
Description
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.
Time Frame
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)
Title
36-Item Short Form Survey (SF-36) version 2.0.
Description
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.
Time Frame
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)
Other Pre-specified Outcome Measures:
Title
Functional ambulation category (FAC)
Description
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.
Time Frame
baseline
Title
Pittsburgh rehabilitation participation scale (PRPS)
Description
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.
Time Frame
at every intervention (from baseline to hospital discharge, an average of 2 months)
Title
the number of adverse events and rehabilitation stops
Description
the number of adverse events and rehabilitation stops
Time Frame
at every intervention (from baseline to hospital discharge, an average of 2 months)
Title
moltality
Description
moltality
Time Frame
at every intervention (from baseline to hospital discharge, an average of 2 months)
Title
duration of mechanical ventilation
Description
duration of mechanical ventilation
Time Frame
at every intervention (from baseline to ICU discharge, an average of 3 weeks)
Title
length of stay in ICU
Description
length of stay in ICU
Time Frame
at every intervention (from baseline to ICU discharge, an average of 3 weeks)
Title
length of stay in the hospital
Description
length of stay in the hospital
Time Frame
at every intervention (from baseline to hospital discharge, an average of 2 months)
Title
the presence of respiratory rehabilitation and application dose
Description
the presence of respiratory rehabilitation and application dose
Time Frame
at every intervention (from baseline to hospital discharge, an average of 2 months)
Title
the presence of occupational therapy and application dose
Description
the presence of occupational therapy and application dose
Time Frame
at every intervention (from baseline to hospital discharge, an average of 2 months)
Title
the number of conventional rehabilitation
Description
the number of conventional rehabilitation
Time Frame
at every intervention (from baseline to hospital discharge, an average of 2 months)
Title
the number of multimodal exercise intervention
Description
the number of multimodal exercise intervention
Time Frame
at every intervention (from baseline to ICU discharge, an average of 3 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Woo Hyung Lee, MD, PhD
Phone
82-10-4640-6283
Email
whlee909@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Soohyun Wi, PhD
Phone
82-10-8098-8022
Email
wish.00118@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Hyung Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soohyun Wi Wi, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hyung-Ik Shin, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sung Eun Hyun, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kwan-Sik Sung, MS
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeong Min Kim, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yae Lim Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soohyun Wi, Ph.D
Phone
821080988022
Email
wish.00118@gmail.com
First Name & Middle Initial & Last Name & Degree
Woo Hyung Lee, MD, Ph.D
Phone
821046406283
Email
whlee909@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Woo Hyung Lee
First Name & Middle Initial & Last Name & Degree
Soo Hyun Wi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs