UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057682 |
|---|---|
| Receipt number | R000065873 |
| Scientific Title | Exploring Imaging Biomarkers for the Evaluation of Exercise-Induced Dynamic Changes in Leg Muscle Function Using Magnetic Resonance Examination |
| Date of disclosure of the study information | 2025/04/22 |
| Last modified on | 2025/04/22 15:14:58 |
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Basic information
Public title
Exploring Imaging Biomarkers for the Evaluation of Exercise-Induced Dynamic Changes in Leg Muscle Function Using Magnetic Resonance Examination
Acronym
Exploring Imaging Biomarkers for the Evaluation of Exercise-Induced Dynamic Changes in Leg Muscle Function Using Magnetic Resonance Examination
Scientific Title
Exploring Imaging Biomarkers for the Evaluation of Exercise-Induced Dynamic Changes in Leg Muscle Function Using Magnetic Resonance Examination
Scientific Title:Acronym
Exploring Imaging Biomarkers for the Evaluation of Exercise-Induced Dynamic Changes in Leg Muscle Function Using Magnetic Resonance Examination
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To dynamically measure various functional changes caused by exercise of the leg muscles in healthy subjects using magnetic resonance examination techniques, and to explorer for imaging biomarkers that can evaluate the dynamic changes in function in the leg muscles.
Basic objectives2
Others
Basic objectives -Others
Dynamic changes in lower leg muscle function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in various measurements during exercise obtained by magnetic resonance testing techniques
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Leg muscle exercise
Interventions/Control_2
person who has experienced physical 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
| 24 | years-old | >= |
Gender
Male
Key inclusion criteria
1. males who are between 18 and 24 years of age at the time of consent
2. who have been a member of an athletic team (preferably short-distance track and field, jumping sports such as basketball and volleyball, soccer, etc.) for at least two years in high school and are still playing the same sports (only those who are assigned to those with athletic experience)
3. able to perform the specified exercise.
4. who agree to undergo the MR scan and can guarantee the safety of the MR scan.
Key exclusion criteria
1. those who have metal devices, etc. inside the body due to past surgeries, etc., or those who are claustrophobic
2. those who have withdrawn their consent to participate in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kubo |
Organization
Fukushima Medical University
Division name
Department of Radiological Sciences, School of Health Sciencens
Zip code
960-8516
Address
10-6 Sakae-machi, Fukushima
TEL
024-581-5577
kubo-h@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kubo |
Organization
Fukushima Medical University
Division name
Department of Radiological Sciences, School of Health Sciencens
Zip code
960-8516
Address
10-6 Sakae-machi, Fukushima
TEL
024-581-5577
Homepage URL
kubo-h@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima 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
Fukushima Medical University Hospital
Address
1 Hikarigaoka, Fukushima
Tel
090-1938-7374
c-kiban@fmu.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 | 04 | Month | 22 | 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 | 16 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 23 | 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 | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065873
