UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054570 |
|---|---|
| Receipt number | R000062321 |
| Scientific Title | Brain-Peripheral Organ Interaction and Exercise Effect: Physiological Study for Extending Healthy Lifespan |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2025/06/05 09:05:48 |
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Basic information
Public title
Brain-Peripheral Organ Interaction and Exercise Effect: Physiological Study for Extending Healthy Lifespan
Acronym
Research on Brain Function and Exercise Effect
Scientific Title
Brain-Peripheral Organ Interaction and Exercise Effect: Physiological Study for Extending Healthy Lifespan
Scientific Title:Acronym
Research on Brain Function and Exercise Effect
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the physiological mechanisms that control the interaction between the brain and peripheral organs, and to examine the effects of age and exercise on the interaction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neurocognitive function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise program (up to 12 months)
Interventions/Control_2
Lifestyle education
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who can provide written informed consent for participation in the study voluntarily.
Individuals between the ages of 18 and 85 at the time of consent, regardless of gender.
Individuals who have sufficient physical fitness to exercise continuously for 30 minutes.
Participants in the exercise training intervention must be under 75 years of age at the start of the study.
Key exclusion criteria
Individuals with a history of heart disease, mental or neurological disorders, cerebrovascular disease, renal failure, or respiratory disorders.
Individuals with dementia (including mild dementia), as assessed by a score of 26 or less on the Mini-Mental State Examination (MMSE).
Individuals whose exercise is limited due to illness or disease.
Individuals with systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher.
Pregnant women or women who may be pregnant.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tarumi |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi Tsukuba, Ibaraki prefecture
TEL
050-3522-3216
takashi.tarumi@aist.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tarumi |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi Tsukuba, Ibaraki prefecture
TEL
050-3522-3216
Homepage URL
takashi.tarumi@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Other
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
National Institute of Advanced Industrial Science and Technology Committee on Bioethics
Address
1-1-1 Higashi
Tel
029-861-2120
safe-life-ml@aist.go.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
| 2024 | Year | 06 | Month | 07 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062321
