UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057559 |
|---|---|
| Receipt number | R000065767 |
| Scientific Title | The combination of low-intensity resistance exercise and electrical muscle stimulation effectively enhances executive function |
| Date of disclosure of the study information | 2025/04/09 |
| Last modified on | 2025/04/09 10:16:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The method to effectively enhance executive function
Acronym
The method to effectively enhance executive function
Scientific Title
The combination of low-intensity resistance exercise and electrical muscle stimulation effectively enhances executive function
Scientific Title:Acronym
The effect of resistance exercise and electrical muscle stimulation on executive function
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The combination of low-intensity resistance exercise and electrical muscle stimulation effectively enhances executive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase in executive function in response to resistance exercise and electrical muscle stimulation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
low-intensity resistance exercise
Interventions/Control_2
electrical muscle stimulation
Interventions/Control_3
combination of low-intensity resistance exercise and electrical muscle stimulation
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) College students aged 18-39
(2) Those who, after receiving a full explanation of their participation in the research, have fully understood it and have given their written consent of their own free will.
Key exclusion criteria
1, Those with color vision and visual problems (due to difficulty in performing cognitive tasks)
2, Those with metabolic diseases (fasting blood glucose level of 110 mg/dL or higher) as well as chronic diseases of the heart, brain, or other organs.
3, Patients who have smoked within 1 year (because the bioavailability of nitric oxide, which affects cognitive function, is affected by smoking)
4, Those who have had more than 200 ml of blood drawn within 12 weeks prior to the start of the study
5, Persons who are deemed inappropriate for the addition of electrical stimulation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu
TEL
0775994134
thashimo@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu
TEL
0775994134
Homepage URL
thashimo@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Takeshi Hashimoto
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Shiga
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu
Tel
0775994175
b-rinri@st.ritsumei.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 | 04 | Month | 09 | 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
17
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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065767
