UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049057 |
|---|---|
| Receipt number | R000055872 |
| Scientific Title | Effects of outdoor therapy in patients in the ICU |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/10/01 00:50:27 |
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Basic information
Public title
Effects of outdoor therapy in patients in the intensive care unit
Acronym
Effects of outdoor therapy in patients in the intensive care unit
Scientific Title
Effects of outdoor therapy in patients in the ICU
Scientific Title:Acronym
Effects of outdoor therapy in patients in the ICU
Region
| Japan |
Condition
Condition
Patients admitted to ICU
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of outdoor air bathing on delirium, sleep during hospitalization, autonomic activity, physical function, and ADL, for patients admitted to the ICU.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Delirium
Key secondary outcomes
sleep, autonomic activity, physical function, ADLs, and outcome 1 year after discharge
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients admitted to the Intensive Care Unit (ICU) of Shinshu University Hospital.
2. Patients who have been in the ICU for more than 7 days.
Key exclusion criteria
1. Patients who entered the ICU two or more times during their hospital stay
2. Patients who died during their stay in the ICU
3. Other patients were deemed inappropriate as subjects by the principal investigator.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Tsukakoshi |
Organization
Shinshu University Hospital
Division name
Department of Rehabilitation
Zip code
3900802
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-0802, Japan
TEL
026337286
daichi226@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Tsukakoshi |
Organization
Shinshu University Hospital
Division name
Department of Rehabilitation
Zip code
3900802
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-0802, Japan
TEL
026337286
Homepage URL
daichi226@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Hospital
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
Shinshu University Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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 | 10 | 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
354
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To date, there have been no reports in Japan or overseas examining the effectiveness of outdoor therapy for ICU patients. This study is expected to contribute to the development of new intervention methods for ICU delirium.
Management information
Registered date
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055872
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
