UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050364 |
|---|---|
| Receipt number | R000057348 |
| Scientific Title | Pilot Study to Develop Indicators in the Recovery Process |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/02/09 13:15:03 |
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Basic information
Public title
Pilot Study to Develop Indicators in the Recovery Process
Acronym
Pilot Study to Develop Indicators in the Recovery Process
Scientific Title
Pilot Study to Develop Indicators in the Recovery Process
Scientific Title:Acronym
Pilot Study to Develop Indicators in the Recovery Process
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Finding an index that correlates with the process of disease progression or recovery would eliminate the need for hospital visits for testing. Therefore, this study will examine an index of physical activity that can monitor the process of disease progression or recovery from disease in daily life.
Basic objectives2
Others
Basic objectives -Others
Exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, the evaluation of physical condition by the EQ-5D-5L is considered correct and is evaluated by the correlation between the EQ-5D-5L and the increase or decrease in activity (walking, standing, and lying down) time calculated from the accelerometer.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise tolerance
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
(1) Persons suffering from cardiac or respiratory diseases that may put the body at risk due to the exercise load.
(2) Persons who are pregnant.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Morita |
Organization
Okayama University
Division name
Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6898
mizuki@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Morita |
Organization
Okayama University
Division name
Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6898
Homepage URL
mizuki@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-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
| 2023 | Year | 04 | 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
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057348
