UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060967 |
|---|---|
| Receipt number | R000067777 |
| Scientific Title | Effects of Running and Sprinting Loads on Achilles Tendon Structure and Recovery Process: A Longitudinal Ultrasound Imaging Study in Track and Field Athletes |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/17 20:52:23 |
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Basic information
Public title
Effects of Long-Distance and Short-Distance Running Loads on Achilles Tendon Structure and Recovery Process: An Ultrasound Imaging Evaluation of Track and Field Athletes
Acronym
Ultrasound Imaging Evaluation of Achilles Tendons in Track and Field Athletes
Scientific Title
Effects of Running and Sprinting Loads on Achilles Tendon Structure and Recovery Process: A Longitudinal Ultrasound Imaging Study in Track and Field Athletes
Scientific Title:Acronym
Ultrasound Imaging Evaluation of Achilles Tendon Structure and Recovery Process in Track and Field Athletes
Region
| Japan |
Condition
Condition
Achilles tendon disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the "normal response profile" and "temporal criteria for complete recovery" of healthy Achilles tendons.
To examine the relationship between functional recovery (such as ankle joint range of motion and muscle strength) and structural recovery of the Achilles tendon.
Measure tendon elongation during repeated sprint running ground contact as a dynamic creep response, serving as a biomarker indicating the tendon's integrated deformation response to exercise load. Analyze how differences in dynamic creep response magnitude affect tendon reactivity and recovery time, establishing foundational data for objective evaluation metrics to aid in managing Achilles tendon injury risk.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation/Measurement Timepoints: Before exercise intervention, Immediately after exercise intervention, 6 hours after exercise intervention, 24 hours after exercise intervention, 48 hours after exercise intervention, 72 hours after exercise intervention
Primary Outcome: Cross-sectional Area (CSA)
Key secondary outcomes
Evaluation/Measurement Timepoints: Pre-exercise intervention, Immediately post-exercise intervention, 6 hours post-exercise intervention, 24 hours post-exercise intervention, 48 hours post-exercise intervention, 72 hours post-exercise intervention
Secondary Outcomes: Tendon thickness, fibrillar pattern, brightness distribution, dynamic creep response (change in free Achilles tendon length), gastrocnemius thickness, passive ankle dorsiflexion range of motion, isometric ankle plantar flexion strength, basic information (height, weight, gender, age), athletic history, training status, recovery time for each item
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sprint
Interventions/Control_2
running
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Members of the Gunma University School of Medicine Track and Field Team
2. Individuals with no history of orthopedic conditions affecting the lower limbs within the past three months
3. Individuals who can undergo measurement using an ultrasound imaging device
4. Individuals who have received an explanation of this study and have provided informed consent
Key exclusion criteria
1. Individuals with a history of surgery on the foot or around the ankle
2. Individuals with a history of Achilles tendon rupture
3. Individuals with less than six months of athletic activity
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Kobayashi |
Organization
Gunma University Graduate School
Division name
Graduate School of Health Sciences, Department of Health Sciences
Zip code
371-8514
Address
39-22 Showa-cho 3-chome, Maebashi City, Gunma Prefecture
TEL
027-220-8972
kobatakku@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Kobayashi |
Organization
Gunma University Graduate School
Division name
Graduate School of Health Sciences, Department of Health Sciences
Zip code
371-8514
Address
39-22 Showa-cho 3-chome, Maebashi City, Gunma Prefecture
TEL
027-220-8972
Homepage URL
kobatakku@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University
Address
39-22 Showa-cho 3-chome, Maebashi City, Gunma Prefecture
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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 | 20 | 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 | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2030 | 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 | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067777
