UMIN-CTR Clinical Trial

Basic information
Public title	A survey on the walking status of patients who need ventilator treatment until they are discharged or transferred to another hospital
Acronym	A survey on the walking status of patients who need ventilator treatment until they are discharged or transferred to another hospital
Scientific Title	Predictors for Gait Independence in Patients who Underwent Mechanical Ventilation in a Critical Care Center
Scientific Title:Acronym	Predictors for Gait Independence in Patients who Underwent Mechanical Ventilation in a Critical Care Center
Region	Japan

Condition
Condition	critically ill patients
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Predictors affecting gait independence during discharge or transfer of critical ill patients who underwent mechanical ventilation in a critical care center
Basic objectives2	Others
Basic objectives -Others	To clarify the difference in HRQOL between the gait independence and non-independence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Independence rate of gait at transfer/discharge (hazard ratio)
Key secondary outcomes	Comparison of walking independence rate among predictors Comparison between grip strength, MRC-ss (muscular strength), HRQOL, and depressive symptoms between two groups (gait independent/gait non-independence)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	MV management is over 48 hours Age: 18 years old or older at the time of obtaining consent Gender: Any Walkable before hospitalization (including walking aids) Rehabilitation prescription from doctor Surgery: Any Enter the advanced lifesaving emergency center A person who, after receiving a sufficient explanation before participating in this research, has obtained an informed consent of the research subject or his/her family.
Key exclusion criteria	Leave the Advanced Emergency and Critical Care Center within 72 hours Cerebrovascular disease Those who have been on artificial respiration management before admission In-hospital death Fractures of the spine, pelvis, and lower limbs that cause lower limb loading Amputation of upper and lower limbs Irreversible (or prolonged) consciousness disorder Spinal cord injury Malignant tumor and other diseases within 6 months of prognosis Those who cannot understand the purpose of research and have difficulty communicating Post-transplantation (due to this hospitalization) Those who had a walker walk before hospitalization Any other person whom the researcher judges to be inappropriate as a research target person
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ryuji Middle name Last name Yoshinaga
Organization	National Hospital Organization Nagasaki Medical Center
Division name	Department of Rehabilitation
Zip code	8568562
Address	2-1001-1 Kubara, Omura-city, Nagasaki
TEL	0957523121
Email	snowboard_atp@yahoo.co.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Kozu
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Physical Therapy Science
Zip code	852-8520
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7900
Homepage URL
Email	ryokozu@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Graduate School of Biomedical Sciences
Address	1-7-1 Sakamoto, Nagasaki
Tel	095-819-7900
Email	snowboard_atp@yahoo.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 03 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	Open public recruiting
Date of protocol fixation	2020 Year 10 Month 05 Day
Date of IRB	2020 Year 10 Month 05 Day
Anticipated trial start date	2020 Year 10 Month 05 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cohort study

Management information
Registered date	2022 Year 08 Month 03 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047223

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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