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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | critically ill patients | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
snowboard_atp@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Cohort study |
Management information | |||||||
Registered date |
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Last modified on |
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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 |