UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057878 |
|---|---|
| Receipt number | R000066153 |
| Scientific Title | Effects of different frequencies of belt electrode-skeletal muscle electrical stimulation on microvascular function and macrovascular hemodynamics |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/05/15 16:36:53 |
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Basic information
Public title
Effects of different frequencies of belt electrode-skeletal muscle electrical stimulation on microvascular function and macrovascular hemodynamics
Acronym
Effects of different frequencies of belt electrode-skeletal muscle electrical stimulation on microvascular function and macrovascular hemodynamics
Scientific Title
Effects of different frequencies of belt electrode-skeletal muscle electrical stimulation on microvascular function and macrovascular hemodynamics
Scientific Title:Acronym
Effects of different frequencies of belt electrode-skeletal muscle electrical stimulation on microvascular function and macrovascular hemodynamics
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of optimal stimulation frequency for belt electrode-skeletal muscle electrical stimulation to improve microvascular function and elucidation of the mechanism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microvascular function of the gastrocnemius muscle before, after, and up to 30 minutes after intervention skeletal muscle electrical stimulation intervention.
Key secondary outcomes
- Metabolic rate of the gastrocnemius muscle before, after and up to 30 minutes after skeletal muscle electrical stimulation intervention.
- Blood flow volume, blood flow velocity, and vessel diameter of the superficial femoral artery before, during, after and up to 30 minutes after skeletal muscle electrical stimulation intervention.
- Blood flow volume, blood flow velocity, and blood vessel diameter of the brachial artery before, during, after and up to 30 minutes after skeletal muscle electrical stimulation intervention.
- Heart rate, stroke volume, and cardiac output before, during, after and up to 30 minutes after skeletal muscle electrical stimulation intervention.
- Lactate levels before, after and up to 30 minutes after skeletal muscle electrical stimulation intervention.
- Blood glucose levels before, after and up to 30 minutes after skeletal muscle electrical stimulation intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
After 10 minutes of resting in a supine position, electrical stimulation at a frequency of 4 Hz is administered for 30 minutes at the maximum tolerated intensity without causing discomfort.
Interventions/Control_2
After 10 minutes of resting in a supine position, electrical stimulation at a frequency of 20 Hz is administered for 30 minutes at the maximum tolerated intensity without causing discomfort.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- The age of the individual at the time of obtaining consent is between 18 and 30 years old.
Those who have received a sufficient explanation of this study, fully understood it, and freely provided written consent to participate in the study.
Key exclusion criteria
-People aged 31 or older.
-People with a history of cardiovascular disease or receiving drug treatment.
-People receiving drug treatment or taking supplements.
-People who have regular exercise habits (150 minutes or more of moderate aerobic exercise or 75 minutes or more of vigorous aerobic exercise per week).
-Other people who the principal investigator deems unsuitable to be study subjects.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hina |
| Middle name | |
| Last name | Kawashiri |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Medical and Welfare Sciences, Department of Health Sciences, Physical Therapy
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
080-6791-7231
hpm25012@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hina |
| Middle name | |
| Last name | Kawashiri |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Medical and Welfare Sciences, Department of Health Sciences, Physical Therapy
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
080-6791-7231
Homepage URL
hpm25012@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
info@nihw.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 | 05 | Month | 15 | 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
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066153
