UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054431 |
|---|---|
| Receipt number | R000062167 |
| Scientific Title | Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase1 |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2024/05/19 20:18:41 |
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Basic information
Public title
Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase1
Acronym
Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase1
Scientific Title
Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase1
Scientific Title:Acronym
Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicator phase1
Region
| Japan |
Condition
Condition
Muscle Fatigue
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Discovering novel biomarkers that change during muscle fatigue to assess muscle fatigue in athletes.
Basic objectives2
Others
Basic objectives -Others
Assessing muscle fatigue in athletes is crucial for performance and injury risk evaluation. While current methods like electromyography and biomarkers have issues with reliability and effort, urine samples offer a non-invasive alternative, rich in biomarkers reflecting body states. This study will use metabolomic analysis of urine to identify new biomarkers for muscle fatigue and establish a simple evaluation method.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urinary metabolite
Key secondary outcomes
Subjective fatigue
Quadriceps and hamstring stretch pain
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) University athletes who belong to the Rikkyo University Athletic Association and are active as athletes.
(2) Those who agree not to be compensated for any events related to this research.
Key exclusion criteria
Individuals who did not give consent for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | NARUTO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Rikkyo University
Division name
College of Sport and Wellness
Zip code
352-8558
Address
1-2-26 Kitano, Niiza-shi, Saitama, Japan
TEL
048-471-7549
naruto-y-ad@rikkyo.ac.jp
Public contact
Name of contact person
| 1st name | NARUTO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Rikkyo University
Division name
College of Sport and Wellness
Zip code
352-8558
Address
1-2-26 Kitano, Niiza-shi, Saitama, Japan
TEL
048-471-7549
Homepage URL
naruto-y-ad@rikkyo.ac.jp
Sponsor or person
Institute
Rikkyo University
Institute
Department
Personal name
NARUTO YOSHIDA
Funding Source
Organization
Rikkyo 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
Rikkyo University
Address
1-2-26 Kitano, Niiza-shi, Saitama, Japan
Tel
048-471-7549
naruto-y-ad@rikkyo.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
| 2024 | Year | 05 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An exercise task (all-out (symptom-limiting) exercise to a linearly progressive exercise load (ramp method) on a bicycle ergometer) is performed to induce fatigue.
Subjective and objective muscle fatigue assessments (VAS assessment and urine sampling) are carried out before, after, one day after and two days after the exercise task (four times in total) to measure changes in various parameters due to muscle fatigue.
Management information
Registered date
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062167
