UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057221 |
|---|---|
| Receipt number | R000065409 |
| Scientific Title | Search for genetic polymorphism to determine interindividual differences in preventive and therapeutic effects of exercise based on the "Jukunen-taiikudaigaku" project |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2025/03/06 11:13:03 |
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Basic information
Public title
Search for genes to determine interindividual differences in preventive and therapeutic effects of exercise
Acronym
Genes to determine interindividual differences in effects of exercise
Scientific Title
Search for genetic polymorphism to determine interindividual differences in preventive and therapeutic effects of exercise based on the "Jukunen-taiikudaigaku" project
Scientific Title:Acronym
Search for genetic polymorphism to determine interindividual differences in preventive and therapeutic effects of exercise
Region
| Japan |
Condition
Condition
Lifestyle-related diseases
Classification by specialty
| Medicine in general | Geriatrics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To search for genetic polymorphism to determine interindividual differences in preventive and therapeutic effects of exercise
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
genetic polymorphism, adherence rate to exercise training, aerobic capacity, muscle strength, symptoms of lifestyle-related diseases
Key secondary outcomes
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who are aged from 30 to 85 years old.
2) Those who can walk independently.
3) Those who perform interval walking training by using the system to remotely prescribe exercise program for individuals.
4) Those who are allowed to participate in the study by their home doctors or doctors in chage if they are patients visting Shinshu University Medical School Hospital.
5) Those who give their informed consent to partipate in the study base on their free will after receiving detailed explanation on the study by face to face. If they are persons in need of care so that they can not make the decision, their representative consenter can do it.
Key exclusion criteria
1) Those who do not meet the inclusion criteria.
2) Those who are judged inappropriate to patrcipate in the study by the primary investigator.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano
TEL
0263-37-2682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Graduate School of Medicine
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263-37-2527
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
| 2025 | Year | 03 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065409
