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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048575
Receipt No. R000047223
Scientific Title Predictors for Gait Independence in Patients who Underwent Mechanical Ventilation in a Critical Care Center
Date of disclosure of the study information 2022/08/03
Last modified on 2022/08/03

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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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