UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060533 |
|---|---|
| Receipt number | R000069037 |
| Scientific Title | Impact of a Function-Oriented Rehabilitation Protocol on Functional Outcomes in ICU Patients: A Historical Control Study |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/31 11:10:27 |
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Basic information
Public title
The Impact of Different Rehabilitation Methods During ICU Admission on Physical Function
Acronym
The Impact of Different Rehabilitation Methods During ICU Admission on Physical Function
Scientific Title
Impact of a Function-Oriented Rehabilitation Protocol on Functional Outcomes in ICU Patients: A Historical Control Study
Scientific Title:Acronym
Impact of a Function-Oriented Rehabilitation Protocol on Functional Outcomes in ICU Patients: A Historical Control Study
Region
| Japan |
Condition
Condition
Critically ill patients requiring mechanical ventilation for 48 hours or more
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to introduce a functional extubation protocol based on the Functional Status Score for the ICU (FSS-ICU) for patients admitted to the ICU, and to examine changes in physical functional outcomes before and after its implementation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional Status Score for the ICU (FSS-ICU) at ICU discharge
Key secondary outcomes
At ICU discharge
ICU Mobility Scale (IMS), Medical Research Council sum score (MRCs)
At hospital discharge
Short Physical Performance Battery (SPPB), Barthel Index
At 90 days after ICU discharge
Hospital Anxiety and Depression Scale (HADS), EQ-5D-5L, Barthel Index
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In the intervention group, a stepwise rehabilitation protocol based on the Functional Status Score for the ICU (FSS-ICU) is implemented for patients during their ICU stay. Rehabilitation is provided at least once daily and includes basic functional activities such as rolling, sitting up, sitting balance, standing, and walking.
Progression of the intervention is determined based on hemodynamic and respiratory status and level of consciousness of the patient, following safety assessment by the treating physician and study investigator.
The historical control group utilized data from ICU patients who underwent rehabilitation using the standard mobilization protocol prior to the introduction of the functional mobilization protocol.
Rehabilitation was generally performed at least once daily, with safety confirmed using the same initiation and discontinuation criteria as the intervention group.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who were admitted to the emergency and critical care center of Nihon University hospital and required mechanical ventilation for 48 hours or longer.
Key exclusion criteria
1)Patients who are unable to understand instructions until ICU discharge due to severe impaired consciousness.
2)Patients admitted for cerebrovascular disease with motor paralysis.
3)Patients who develop severe complications during hospitalization.
4)Patients who required total assistance for all activities of daily living prior to hospital admission.
5)Patients who refused to participate in this study.
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Yanagisawa |
Organization
Nihon University Hospital
Division name
Rehabilitation Room
Zip code
101-8309
Address
1-6, Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
yanagisawa.yuya@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Yanagisawa |
Organization
Nihon University Hospital
Division name
Rehabilitation Room
Zip code
101-8309
Address
1-6, Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
yanagisawa.yuya@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Yanagisawa Yuya
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital
Address
1-6, Kanda Surugadai, Chiyoda-ku, Tokyo
Tel
03-3293-1711
yanagisawa.yuya@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
20250901
Org. issuing International ID_1
Nihon University Hospital Clinical Research Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069037
