UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060776 |
|---|---|
| Receipt number | R000069537 |
| Scientific Title | Effects of Electrical Stimulation Applied to the Entire Lower-Limb Musculature on Energy Metabolism |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/27 16:44:10 |
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Basic information
Public title
Effects of Electrical Stimulation Applied to the Entire Lower-Limb Musculature on Energy Metabolism
Acronym
Effects of Electrical Stimulation Applied to the Entire Lower-Limb Musculature on Energy Metabolism
Scientific Title
Effects of Electrical Stimulation Applied to the Entire Lower-Limb Musculature on Energy Metabolism
Scientific Title:Acronym
Effects of Electrical Stimulation Applied to the Entire Lower-Limb Musculature on Energy Metabolism
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of electrical stimulation applied to the entire lower-limb musculature on energy metabolism and to examine its applicability for individuals who are unable to perform exercise at sufficient intensity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
oxygen consumption (VO2), blood glucose level, blood lactate concentration, Borg rating of perceived exertion (RPE)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical Stimulation (ES) condition.
Electrical stimulation was applied to the entire lower-limb musculature, with electrode placement over the abdomen (above the iliac crest), both thighs (above the patella), and both lower legs (above the medial and lateral malleoli). Participants were positioned in the supine position. The stimulation mode was set to the metabolic mode (4 Hz). The pulse width was adjusted within the manufacturer-specified range of 56-260 usec, and an exponentially ramping waveform was used at the onset of stimulation. The maximum output current was 48 mA. Stimulation intensity was regulated using a 10-point pain scale and was adjusted as needed to reach the highest tolerable level without discomfort, corresponding approximately to a rating of "8".
Interventions/Control_2
Control condition (CC).
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
students who agreed to participate in the study and submitted a signed informed-consent form
Key exclusion criteria
individuals who are receiving outpatient treatment for illness or injury, or those who have pain in the lower back or lower limbs
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokoha University
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
431-2102
Address
1230 Miyakoda-cho, Hamana-ku, Hamamatsu City
TEL
053-428-3683
ytakeshi@hm.tokoha-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokoha University
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
431-2102
Address
1230 Miyakoda-cho, Hamana-ku, Hamamatsu City
TEL
053-428-3683
Homepage URL
ytakeshi@hm.tokoha-u.ac.jp
Sponsor or person
Institute
Tokoha University
Institute
Department
Personal name
Funding Source
Organization
Tokoha University
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
Tokoha University
Address
1230 Miyakoda-cho, Hamana-ku, Hamamatsu City
Tel
053-428-3511
y-mizutani@hm.tokoha-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
常葉大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 10 | 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
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069537
