UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063415 |
|---|---|
| Receipt number | R000072578 |
| Scientific Title | Electrical muscle stimulation on arterial function and cognitive function: a randomized controlled trial |
| Date of disclosure of the study information | 2026/10/26 |
| Last modified on | 2026/10/26 11:44:58 |
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Basic information
Public title
Usefulness of electrical muscle stimulation for arterial and cognitive function
Acronym
EMS for arterial and cognitive function
Scientific Title
Electrical muscle stimulation on arterial function and cognitive function: a randomized controlled trial
Scientific Title:Acronym
EMS training for arterial and cognitive function
Region
| Japan |
Condition
Condition
Cardiovascular disease and dementia (prevention)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of electrical muscle stimulation training on arterial and cognitive function in middle-aged and older women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulse Wave Velocity, Flow-Mediated Dilatation, Montreal Cognitive Assessment
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
| Device,equipment |
Interventions/Control_1
EMS training group: Participants receive electrical muscle stimulation using an electrical stimulator in the supine position, applied to the abdomen and back for 20 min, followed by the thighs for 20 min (40 min/day, 5 days/week, for 8 weeks, at home). The stimulation intensity is individually set at a tolerable level and gradually increased as tolerance improves. Participants maintain their usual lifestyle during the intervention period.
Interventions/Control_2
Control group: Participants receive no intervention and maintain their usual lifestyle, including physical activity and dietary habits, for 8 weeks.
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
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Postmenopausal women with more than 12 months since the last menstrual period
No regular exercise habits
Provision of written informed consent after receiving an explanation of the study
Key exclusion criteria
Participation in structured exercise for at least 30 min per session on two or more days per week
Smoking
Hormone replacement therapy
Use of medication for lifestyle-related diseases, such as diabetes or hypertension
Signs, symptoms, or a history of overt chronic disease, including cardiovascular disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Okamoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-0966
tokamoto@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Okamoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-0966
Homepage URL
tokamoto@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
Tel
03-5706-0966
tokamoto@nittai.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 | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://nittaidai.repo.nii.ac.jp/records/2000397
Publication of results
Unpublished
Result
URL related to results and publications
https://nittaidai.repo.nii.ac.jp/records/2000397
Number of participants that the trial has enrolled
36
Results
Significant group x time interactions were observed in baPWV, FMD, and MoCA-J total and delayed recall scores. In the EMS group, baPWV decreased (p = 0.001), and FMD (p < 0.001), MoCA-J total score (p < 0.001), and delayed recall score (p < 0.001) increased significantly, whereas no significant changes were observed in the control group. After the intervention, the MoCA-J total score was significantly higher in the EMS group than in the control group (p = 0.020).
Results date posted
| 2026 | Year | 10 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-one postmenopausal women (age, 59.2 +/- 7.2 years; EMS group, n = 16; control group, n = 15). All participants were non-smokers without regular exercise habits. No significant differences were observed between the groups in physical characteristics, arterial function, or cognitive function at baseline.
Participant flow
Assessed for eligibility, 45; excluded, 3; declined, 6. Randomized, 36 (EMS, 19; control, 17). Withdrew after allocation, 1 per group; excluded for missing data, EMS 2 and control 1. Analyzed, 31 (EMS, 16; control, 15).
Adverse events
None
Outcome measures
Primary: baPWV, FMD, and MoCA-J (total and delayed recall scores)
Secondary: TMT, blood pressure, AIx@75, knee extension strength, quadriceps cross-sectional area, body composition, and blood biochemical parameters
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 26 | 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 | 10 | Month | 26 | Day |
Last modified on
| 2026 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072578
