UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060909 |
|---|---|
| Receipt number | R000069711 |
| Scientific Title | Estimating Delayed Onset Muscle Soreness (DOMS) Using Segmental-Bioelectrical Impedance Spectroscopy (S-BIS) |
| Date of disclosure of the study information | 2026/03/12 |
| Last modified on | 2026/03/12 15:12:48 |
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Basic information
Public title
Estimating Delayed Onset Muscle Soreness (DOMS) Using Segmental-Bioelectrical Impedance Spectroscopy (S-BIS)
Acronym
Estimating Delayed Onset Muscle Soreness (DOMS) Using Segmental-Bioelectrical Impedance Spectroscopy (S-BIS)
Scientific Title
Estimating Delayed Onset Muscle Soreness (DOMS) Using Segmental-Bioelectrical Impedance Spectroscopy (S-BIS)
Scientific Title:Acronym
Estimating Delayed Onset Muscle Soreness (DOMS) Using Segmental-Bioelectrical Impedance Spectroscopy (S-BIS)
Region
| Japan |
Condition
Condition
healthy male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will evaluate the effectiveness of Segmental Bioelectrical Impedance Spectroscopy (S-BIS) in estimating Delayed Onset Muscle Soreness (DOMS) in healthy men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
segmental bioelectrical impedance spectroscopy (S-BIS), maximum voluntary contraction (MVC), electromyography (EMG), and biochemical markers including creatine kinase (CK) and myoglobin (Mb)
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
upper limb exercise
Interventions/Control_2
lower limb exercise
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
(1)Aged 10-40 years
(2)Male
(3)Individuals who have provided written informed consent to participate in the study(3)
Key exclusion criteria
(1) Individuals with a history of surgery in the upper or lower limbs.
(2) Individuals who have experienced muscle pain in the upper or lower limbs within 3 months prior to the start of the study.
(3) Individuals who have been performing regular resistance training for the upper or lower limbs within the past 6 months.
(4) Individuals with a history of neuromuscular diseases.
(5) Individuals with metabolic diseases.
(6) Individuals with respiratory diseases.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Yamada |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8586
yosuke.yamada.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hyeon-Ki |
| Middle name | |
| Last name | Kim |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8586
Homepage URL
hyeon-ki.kim.c8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@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 | 03 | Month | 12 | 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 | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069711
