UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060586 |
|---|---|
| Receipt number | R000069281 |
| Scientific Title | PET study on skeletal muscle activity: effects of postures and electric stimulation |
| Date of disclosure of the study information | 2026/02/19 |
| Last modified on | 2026/02/18 17:30:59 |
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Basic information
Public title
PET study on the effects of postures and electric stimulation on skeletal muscle activity
Acronym
skeletal muscle PET on postures and electric stimulation
Scientific Title
PET study on skeletal muscle activity: effects of postures and electric stimulation
Scientific Title:Acronym
PETSMA study
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We performed metabolic imaging of the lower leg skeletal muscle groups and brain metabolism during calf raises (heel raises) in the standing posture used in daily life, quantifying changes in skeletal muscle activity dynamics during postural changes. We also examined the relationship between changes in muscle activity due to postural changes and brain activity.
Basic objectives2
Others
Basic objectives -Others
We will perform metabolic imaging of skeletal muscle and the brain during voluntary movement using electrical stimulation (EMS) to skeletal muscle and a bicycle ergometer. This will clarify the differences in tissue metabolism between EMS to skeletal muscle (an involuntary movement) and voluntary movement.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study compares changes in muscle activity dynamics during exercise due to postural changes and the effects of electrical stimulation on movement with voluntary movement. Positron Emission Tomography (PET) using the glucose analog FDG allows investigation of skeletal muscle dynamics during low- to moderate-intensity exercise. The exercises include calf raises and low-intensity cycling, lasting approximately 30 minutes to ensure safety.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Blood Collection and Exercise Safety Management (Heart Rate Measurement)
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy adult males
(2) Individuals aged 20 to 40 with regular exercise habits (25 participants): Engaging in exercise at least once per week
(3) Right-handed individuals
(4) Individuals who agree to be informed of any incidental findings discovered during the examination process
Key exclusion criteria
(1) Individuals with abnormalities detected in brain structure via MRI.
(2) Individuals with contraindications for MR examinations
(3) Individuals with a history of drug or food allergies
(4) Individuals who have experienced discomfort from injections or IV drips.
(5) Individuals determined through physical fitness testing to lack sufficient physical capacity to participate in this study.
(6) Patients with psychiatric disorders or mental symptoms that make study participation difficult.
(7) Individuals with significant impairment in their ability to understand the study content.
(8) Individuals with obesity (BMI 25 or higher). (To ensure safety during exercise)
(9) Individuals with diabetes.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Tohoku University
Division name
Research Center for Accelerator and Radioisotope Science
Zip code
980-8578
Address
6-3Aoba, Aramaki, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-795-7800
manabu.tashiro.a2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Tohoku University
Division name
Research Center for Accelerator and Radioisotope Science
Zip code
980-8578
Address
6-3Aoba, Aramaki, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-795-7800
Homepage URL
manabu.tashiro.a2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
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
Tohoku University Hospital Clinical Research Ethics Committee
Address
2-1 Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
Tel
022-728-4105
ec-hosp@grp.tohoku.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 | 02 | Month | 19 | 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
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2029 | 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 | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069281
