UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033196 |
|---|---|
| Receipt number | R000037851 |
| Scientific Title | Effects of activities of daily living training postoperatively started in intensive care units on delirium after cardiovascular surgery |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/01/20 08:13:06 |
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Basic information
Public title
Effects of activities of daily living training postoperatively started in intensive care units on delirium after cardiovascular surgery
Acronym
Effects of activities of daily living training postoperatively started in intensive care units on delirium after cardiovascular surgery
Scientific Title
Effects of activities of daily living training postoperatively started in intensive care units on delirium after cardiovascular surgery
Scientific Title:Acronym
Effects of activities of daily living training postoperatively started in intensive care units on delirium after cardiovascular surgery
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiovascular surgery | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For delirium after cardiovascular surgery, investigate its duration and ADL. Then, we aim to improve ADL and delirium by conducting ADL training from ICU.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measure(FIM)
Key secondary outcomes
JAPAN-NEECHAM Confusion Scale(J-NCS)
Intensive Care Delirium Screening Checklist(ICDSC)
Confusion Assessment Method for the ICU(CAM-ICU)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
ICU intervention group
Start ADL training from the ICU staffing period
Intervention period: Length of hospital stay(About 14 to 30 days)
Training time: 20 to 40 minutes/days
Interventions/Control_2
Non-ICU intervention group Start ADL training after leaving The ICU as before Intervention period: Length of hospital stay (About 14 to 30 days) Training time: 20 to 40 minutes/day
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who underwent open chest surgery during waiting hospitalization
2)Rehabilitation intervention is possible from the next day of surgery
Key exclusion criteria
Ventilator management
Circulatory kinetic defect
Conscious disturbance
When intervention is canceled due to medical judgment of the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Sakashita |
Organization
Fukuokatokushukai hospital of tokushukai medical Corporation
Division name
Rehabilitation
Zip code
816-0864
Address
4-5 Sukukita Kasuga Fukuoka Prefecture,Japan 816-0864
TEL
0925736622
stap6997@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Sakashita |
Organization
Fukuokatokushukai hospital of tokushukai medical Corporation
Division name
Rehabilitation
Zip code
816-0864
Address
4-5 Sukukita Kasuga Fukuoka Prefecture,Japan 816-0864
TEL
0925736622
Homepage URL
stap6997@yahoo.co.jp
Sponsor or person
Institute
Fukuokatokushukai hospital of tokushukai medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Fukuokatokushukai hospital of tokushukai medical Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
International Medical Welfare University Graduate School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuokatokushukai hospital of tokushukai medical Corporation
Address
4-5 Sukukita Kasuga Fukuoka Prefecture,Japan 816-0864
Tel
0925736622
stap6997@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
| 2018 | Year | 07 | Month | 01 | 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
41
Results
ADL training starting from the postoperative ICU for postoperative delirium patients was suggested to increase spontaneity of ADL performance and to achieve early acquisition of ADL, but no effect was found to lead to delirium disappearance Was.
Results date posted
| 2020 | Year | 01 | Month | 20 | Day |
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037851
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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