UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028633 |
|---|---|
| Receipt number | R000032760 |
| Scientific Title | The investigation of reliability and validity in the N-terminal fragment of titin in urine as muscle damage markers for eccentric exercise-induced muscle damage |
| Date of disclosure of the study information | 2017/08/12 |
| Last modified on | 2021/10/21 06:38:37 |
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Basic information
Public title
The investigation of reliability and validity in the N-terminal fragment of titin in urine as muscle damage markers for eccentric exercise-induced muscle damage
Acronym
The investigation of reliability and validity in the N-terminal fragment of titin in urine
Scientific Title
The investigation of reliability and validity in the N-terminal fragment of titin in urine as muscle damage markers for eccentric exercise-induced muscle damage
Scientific Title:Acronym
The investigation of reliability and validity in the N-terminal fragment of titin in urine
Region
| Japan |
Condition
Condition
Eccentric exercise-induced muscle damage
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of present study is investigation of relationship between traditional muscle damage maker in blood and the N-terminal fragment of titin in urine, in order to clarify the reliability and validity in the N-terminal fragment of titin in urine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Titin fragment concentration in urine during 24 to 48 hours after eccentric exercise
Key secondary outcomes
muscle soreness
Range of motion
upper arm circumference
Creatine kinase activity
Aldolase activity
Myoglobin concentration
Aspartate aminotransferase activity
Alanine transferase activity
Lactate dehydrogenase activity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention period will be 1 day, and until the 2 to 7 day will be the observation duration. Contents of the intervention will work out 3 sets of eccentric contraction exercise 10 times.
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
Key inclusion criteria
1.Those who obtain written consent from the subject concerning research participation.
2.The 20 to 30 years old healthy male.
Key exclusion criteria
1.Those who regularly conduct training during the past half year.
2.Those who has injury sickness which impedes the performance of this research.
3.Persons who are taking supplements, medicines, etc. on a daily basis.
4.Those who experienced blood collection of 200 ml or more within 12 weeks of the start of the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Okada |
Organization
Waseda University
Division name
faculty of sport science
Zip code
202 0021
Address
3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL
08030438030
kato@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | kato |
Organization
Waseda University
Division name
Sport science graduate course
Zip code
202 0021
Address
2-7-5 Higashifushimi, Nishitokyo city, Tokyo
TEL
08030438030
Homepage URL
kato@yahoo.co.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Procedures concerning Research with Human Subjects in Waseda university
Address
1-104 Totsukamachi, Shinjuku-ku, Tokyo 169-8050 Waseda University Research and Development Center, 120-4, 2nd floor
Tel
03-5272-4652
rinri@list.waseda.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
早稲田大学所沢キャンパス
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 12 | 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
17
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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032760
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