UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063305 |
|---|---|
| Receipt number | R000072463 |
| Scientific Title | Effects of Functional Insole/Shoe Use on Physiological and Perceptual Recovery After Long-Distance Running |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/10/16 10:00:01 |
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Basic information
Public title
Effects of Insole/Shoe Use on Recovery After Long-Distance Running
Acronym
Recovery After Long-Distance Running
Scientific Title
Effects of Functional Insole/Shoe Use on Physiological and Perceptual Recovery After Long-Distance Running
Scientific Title:Acronym
Functional Insole/Shoe Use and Physiological and Perceptual Recovery After Long-Distance Running
Region
| Japan |
Condition
Condition
muscle fatigue / muscle soreness
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of functional insole/shoe use on physiological and perceptual recovery after long-distance running.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle strength / muscle soreness
Key secondary outcomes
dynamic balance
muscle stiffness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will wear functional insoles/shoes (grabbing shoes) for 72 hours after long-distance running.
Interventions/Control_2
Participants will wear control shoes that do not have functional features for 72 hours after long-distance 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older.
Individuals who belong to a university long-distance running club and regularly engage in running training.
Individuals who are able to safely complete a 20-km run.
Individuals who are able to comply with the assigned footwear intervention and participate in all scheduled assessments.
Individuals who provide written informed consent after receiving a full explanation of the study.
Key exclusion criteria
Individuals with lower-limb or low-back pain, injury, or musculoskeletal disorders that may affect running or outcome assessments.
Individuals with cardiovascular, respiratory, metabolic, or other medical conditions that may interfere with safe completion of a 20-km run.
Individuals who regularly use medications that may affect muscle function, muscle soreness, or post-exercise recovery.
Individuals with fever, acute infection, or any other health condition considered inappropriate for exercise at the time of the study.
Individuals with foot conditions that prevent appropriate use of the study footwear.
Individuals judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Yanaoka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima
TEL
0824246846
yanaoka@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Yanaoka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1, kagamiyama, Higashi-Hiroshima, Hiroshima
TEL
0824246846
Homepage URL
yanaoka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
BMZ, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
BMZ, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Board in the Graduate School of Humanities and Social Sciences
Address
1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima
Tel
082-424-6705
kyoiku-in@office.hiroshima-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 | 10 | Month | 31 | 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 | 20 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 10 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072463
