UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061386 |
|---|---|
| Receipt number | R000070235 |
| Scientific Title | Elucidation of efficient running patterns based on the integrated analysis of muscle structural and metabolic characteristics and running biomechanics |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 11:26:03 |
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Basic information
Public title
Development of efficient running patterns based on muscle structural and metabolic characteristics
Acronym
Muscle characteristics and efficient running
Scientific Title
Elucidation of efficient running patterns based on the integrated analysis of muscle structural and metabolic characteristics and running biomechanics
Scientific Title:Acronym
Integration of muscle characteristics and running biomechanics
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between muscle structural and metabolic characteristics and running biomechanics, and to identify the factors that determine individually optimal and efficient running patterns.
Basic objectives2
Others
Basic objectives -Others
Nothing
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Energy cost during steady-state running at a fixed speed (running economy)
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
Diagnosis
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Participants undergo measurements of lower-limb muscle morphological and metabolic characteristics using MRI, followed by treadmill running at fixed speeds. During running, running economy and biomechanics are assessed using respiratory gas analysis and motion capture.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will include 30 male and female endurance runners aged 18-30 years who have achieved a personal best marathon time within the past year of under 4 hours for males and under 4 hours 30 minutes for females, or who have achieved an equivalent performance level based on the World Athletics (WA) scoring system using race distances of 5 km or longer. The corresponding WA scores are 54 points for males and 259 points for females. In addition, 30 healthy male and female adults aged 18-30 years who do not engage in running more than twice per week will also be included.
Key exclusion criteria
-Individuals who do not meet the specified age range.
-Endurance runners who have not performed long-distance running (3 km or more per session, 2 times or more per week) within the past 6 months.
-Individuals with a history of Achilles tendon rupture or anterior cruciate ligament injury within the past 6 months, or those currently restricted from exercise by a physician.
-Individuals currently undergoing treatment for injury or illness.
-Individuals with mental or physical impairments (psychiatric or visual disorders) that may interfere with study participation.
-Individuals requiring assistive devices for daily activities due to injury or disability.
-Individuals experiencing pain that prevents comfortable execution of the running tasks specified in this study.
-Individuals with a history of claustrophobia or panic disorder.
-Individuals unable to remain still during measurements.
Pregnant individuals.
-Individuals with a history of epileptic seizures.
-Individuals with implanted medical devices such as cardiac pacemakers, defibrillators, or artificial heart valves.
-Individuals with metal in the body (orthodontic appliances, dental prostheses, depending on material, surgical clips, etc.).
-Individuals with tattoos (due to potential interaction with magnetic fields).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Isaka |
| Middle name | |
| Last name | Tadao |
Organization
Ritsumeikan University
Division name
Faculty of Sport & Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga, Japan
TEL
075-465-8144
isaka@se.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Eihara |
| Middle name | |
| Last name | Yuuri |
Organization
Ritsumeikan University
Division name
Research Organization of Science and Technology
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga, Japan
TEL
080-5320-7338
Homepage URL
e-uri@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University Research Ethics Committee for Human Subjects
Address
1-1-1 Nojihigashi, Kusatsu, Shiga, Japan
Tel
077-599-4175
b-rinri@st.ritsumei.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 | 04 | Month | 27 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2029 | Year | 03 | Month | 01 | 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 | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070235
