UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062634 |
|---|---|
| Receipt number | R000071516 |
| Scientific Title | Effects of exercise on aging clocks |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/20 13:39:58 |
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Basic information
Public title
The effect of exercise training on the salivary epigenetic clock
Acronym
The effect of exercise on the salivary epigenetic clock
Scientific Title
Effects of exercise on aging clocks
Scientific Title:Acronym
The effect of exercise on the salivary epigenetic clock
Region
| Japan |
Condition
Condition
N.A.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of exercise training on biological aging based on salivary DNA methylation in healthy middle-aged men and women aged 40-55 years.
Basic objectives2
Others
Basic objectives -Others
To assess intervention effects by comparing with existing research data (such as historical control data) or by adjusting for imbalances in background factors, propensity score matching using a nearest-neighbor algorithm will be applied. Covariates including age, sex, BMI, and baseline lifestyle habits will be incorporated. Participants with the most similar logit-transformed propensity scores will be matched in a 1:1 ratio via nearest-neighbor search. By conducting parallel-group comparisons with adjusted background factors, we will exploratorily infer the pure causal effect of exercise intervention on salivary DNA methylation age.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The salivary DNA methylation age
Key secondary outcomes
Morphological Parameters (Height, Weight, Body Composition)
Physical Fitness Parameters (Chester Step Test, Handgrip Strength, Vertical Jump, Sit and Reach Test)
Cognitive Functions (Stroop Task, Flanker Task, N Back Task)
Psychological Functions (WHO QOL 26, POMS2, PSS, K10, Physical Effort Scale, VAS)
Lifestyle Habits (PSQI, BDHQ, MEQ, Basic Information Questionnaire)
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Exercise training Group
Interventions/Control_2
Control group
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
| 40 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy men and women aged 40 to 55 years
Individuals with no regular exercise habits for the past 2 years
Individuals with a BMI between 18.5 and 30.0 kg/m2
Individuals who can participate in a 3-month exercise program consisting of 3 sessions per week during the study period
Individuals who provide written informed consent to participate in the study
Key exclusion criteria
Individuals who do not provide informed consent
Individuals who are medically restricted/prohibited from exercising
Individuals currently participating in other clinical studies
Individuals otherwise deemed unsuitable for study participation by the investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center, Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8824
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Kawamura |
Organization
Tohoku University
Division name
Smart-Aging Research Center, Institute of Development, Aging and Cancer
Zip code
022-717-8824
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8824
Homepage URL
takuji.kawamura.b8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Yasuyuki Taki
Funding Source
Organization
JAPAN POST HOLDINGS Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2026 | Year | 08 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071516
