UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057590 |
|---|---|
| Receipt number | R000065803 |
| Scientific Title | Establishment of Exercise Intensity Indicators Using Surface Electromyography as an Alternative to Cardiopulmonary Exercise Testing |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/04/11 16:58:30 |
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Basic information
Public title
Establishment of Exercise Intensity Indicators Using Surface Electromyography as an Alternative to Cardiopulmonary Exercise Testing
Acronym
Establishment of Exercise Intensity Indicators Using Surface Electromyography as an Alternative to Cardiopulmonary Exercise Testing
Scientific Title
Establishment of Exercise Intensity Indicators Using Surface Electromyography as an Alternative to Cardiopulmonary Exercise Testing
Scientific Title:Acronym
Establishment of Exercise Intensity Indicators Using Surface Electromyography as an Alternative to Cardiopulmonary Exercise Testing
Region
| Japan |
Condition
Condition
Healthy university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a non-invasive method for measuring the anaerobic threshold, this study aims to clarify the correspondence between the anaerobic threshold in cardiopulmonary exercise testing and the electromyographic threshold derived from surface electromyography.
Basic objectives2
Others
Basic objectives -Others
To establish a non-invasive method for measuring the anaerobic threshold, this study aims to clarify the correspondence between the anaerobic threshold in cardiopulmonary exercise testing and the electromyographic threshold derived from surface electromyography.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correspondence between anaerobic threshold and electromyographic threshold
Key secondary outcomes
Relationship between electromyographic threshold and expiratory gas analysis parameters, and the association between frequency changes in surface electromyography and knee joint torque variations
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Performing cardiopulmonary exercise testing using a bicycle ergometer
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Individuals 18 years of age or older with capacity for self-determination
Males
University students enrolled in the Department of Physical Therapy, Faculty of Health and Medical Care, Saitama Medical University
Those who have provided consent to participate in this research
Key exclusion criteria
Those with musculoskeletal disorders that impede exercise on a bicycle ergometer
Those with conditions that interfere with the attachment of electrodes to the skin
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Tobita |
Organization
Saitama Medical University
Division name
Department of Physical Therapy Faculty of Health and Medical Care
Zip code
350-0496
Address
981 Kawakado, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-295-1001
k_tobita@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Tobita |
Organization
Saitama Medical University
Division name
Department of Physical Therapy Faculty of Hearth and Medical Care
Zip code
350-0496
Address
981 Kawakado, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-295-1001
Homepage URL
k_tobita@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical 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 of Saitama Medical University
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
049-276-2143
rinri@saitama-med.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
埼玉医科大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | 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
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065803
