Critically Ill PatientNCT05868070
Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients
A study testing Conventional rehabilitation plus multimodal exercise in people with Critically Ill Patient and Intensive Care Unit Acquired Weakness, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Critically Ill Patient, Intensive Care Unit Acquired Weakness
- What is being tested?
- Conventional rehabilitation plus multimodal exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 45
- Admission to ICU ≤ 72 hours
- Patient deemed to need ≥ 48 hours of ICU care
- Premorbid functional ambulation category≥ 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Soohyun Wi, Ph.D, 821080988022, wish.00118@gmail.com
Woo Hyung Lee, MD, Ph.D, 821046406283, whlee909@snu.ac.kr
About this study
Official title: 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.
- Being tested
- Conventional rehabilitation plus multimodal exercise
- Keywords
- clinical trial, critically ill patient, in-bed cycling, in-bed stepping, intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilitation plus multimodal exerciseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Conventional rehabilitation plus multimodal exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number and percentage of completed in-bed cycling/stepping sessions
the number and percentage of completed in-bed cycling/stepping sessions
Measured: 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
Measured: 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
Measured: 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
the interval from ICU admission to the first session of in-bed cycling/stepping
Measured: 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
Measured: 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
Measured: 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
Measured: at every intervention (from baseline to hospital discharge, an average of 2 months)
the number of adverse events
the number of adverse events
Measured: 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.
Measured: 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.
Measured: baseline-ICU discharge (an average of 3 weeks)
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.
Measured: baseline
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.
Measured: 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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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)
days to initiate ambulation (FAC ≥2)
days to initiate ambulation (FAC ≥2)
Measured: at every intervention (from baseline to hospital discharge, an average of 2 months)
mortality-28 days
mortality-28 days
Measured: at every intervention (from baseline to hospital discharge, an average of 2 months)
duration of mechanical ventilation
duration of mechanical ventilation
Measured: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
length of stay in the ICU
length of stay in the ICU
Measured: 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
Measured: at every intervention (from baseline to hospital discharge, an average of 2 months)
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.
Measured: 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
Measured: 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.
Measured: at every intervention (from baseline to hospital discharge, an average of 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start10 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically Ill PatientStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Hyung Lee, Seoul National University Hospital
- Investigators
- Woo Hyung Lee, MD, PhD, Principal investigator, Seoul National University HospitalSoohyun Wi Wi, PhD, Study director, Seoul National University HospitalHyung-Ik Shin, MD, PhD, Study director, Seoul National University HospitalSung Eun Hyun, MD, PhD, Study director, Seoul National University HospitalKwan-Sik Sung, MS, Study director, Seoul National University HospitalJeong Min Kim, MD, Study director, Seoul National University HospitalYae Lim Lee, MD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868070
- Sponsor's protocol ID
- 0720234107
- Other IDs
- 202013C18
- Status last verified
- Jan 2024
- First submitted
- 2 May 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38728323
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients: A Study Protocol for a Pilot Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05868070
- Acronym / sponsor ID
- 0720234107
- Keywords
- clinical trial, critically ill patient, in-bed cycling, in-bed stepping, intensive care unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Conventional rehabilitation plus multimodal exerciseConventional 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 45
- Admission to ICU ≤ 72 hours
- Patient deemed to need ≥ 48 hours of ICU care
- Premorbid functional ambulation category≥ 2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional rehabilitation plus multimodal exerciseDepending 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. | Device | Conventional rehabilitation plus multimodal exercise |
Primary outcome
the number and percentage of completed in-bed cycling/stepping sessions
Time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
the number and percentage of completed in-bed cycling/stepping sessions
the duration and percentage of in-bed cycling/stepping sessions
Time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
the duration and percentage of in-bed cycling/stepping sessions
the number of cessations of in-bed cycling/stepping sessions
Time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
the number of cessations of in-bed cycling/stepping sessions
25 secondary outcomes
the interval from ICU admission to the first session of in-bed cycling/stepping
Time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
the number and percentage of completed conventional rehabilitation sessions
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
the duration and percentage of conventional rehabilitation sessions
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
the number of cessations of conventional rehabilitation sessions
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
the number of adverse events
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
the confusion assessment method for the ICU (CAM-ICU)
Time frame: baseline-ICU discharge (an average of 3 weeks)
Richmond agitation-sedation scale (RASS)
Time frame: baseline-ICU discharge (an average of 3 weeks)
Functional ambulation category (FAC)
Time frame: baseline
Functional status score (FSS-ICU)
Time frame: baseline-ICU discharge (an average of 3 weeks)
Short physical performance battery score (SPPB)
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)
de Morton Mobility Index (DEMMI)
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)
Falls efficacy scale (FES)
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)
Activities-specific balance confidence scale (ABC)
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)
Sum of medical research council (MRC)
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)
Hand grip strength (HGS)
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)
Modified barthel index (MBI)
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)
36-Item Short Form Survey (SF-36) version 2.0.
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)
days to initiate ambulation (FAC ≥2)
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
mortality-28 days
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
duration of mechanical ventilation
Time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
length of stay in the ICU
Time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
length of stay in the hospital
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
Pittsburgh rehabilitation participation scale (PRPS)
Time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)
concomitant occupational therapy and its application dose
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
concomitant pulmonary rehabilitation and its application dose
Time frame: at every intervention (from baseline to hospital discharge, an average of 2 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Derived from this study: PubMed 38728323Wi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Hyung Lee, MD, PhD principal investigator
Seoul National University Hospital
Soohyun Wi Wi, PhD study director
Seoul National University Hospital
Hyung-Ik Shin, MD, PhD study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional rehabilitation plus multimodal exercise in people with Critically Ill Patient and Intensive Care Unit Acquired Weakness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woo Hyung Lee, MD, PhD (82-10-4640-6283, whlee909@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number and percentage of completed in-bed cycling/stepping sessions (time frame: at every intervention (from baseline to ICU discharge, an average of 3 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.