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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036781
Receipt No. R000041911
Scientific Title Change in concentration of urinary titin N-terminal Fragment after high intensity bicycle exercise
Date of disclosure of the study information 2019/05/17
Last modified on 2019/05/17

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Basic information
Public title Change in concentration of titin N terminal fragment which new muscle damage marker in urine after high intensity bicycle exercise
Acronym Change in urinary muscle damage marker after endurance exercise
Scientific Title Change in concentration of urinary titin N-terminal Fragment after high intensity bicycle exercise
Scientific Title:Acronym Concentration of titin fragment after high intensity bicycle exercise
Region
Japan

Condition
Condition Exercise induced muscle damage
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although change in concentration of urinary titin N-terminal fragment after high intensity anaerobic exercise including eccentric contraction have been known, change in concentration after aerobic exercise is not clear. Therefore, this study aimed to clarify the change in concentration after endurance exercise excluding eccentric contraction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change in concentration of urinary titin fragment between 24 to 144 hours after endurance exercise
Key secondary outcomes muscle soreness
circumference
Creatine kinase activity
Aldolase activity
Myoglobin concentration
Aspartate aminotransferase activity
Alanine transferase activity
Lactate dehydrogenase activity
Aerobic capacity
Muscle hardness

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 points will be 3 days, and until the 4 to 7 day will be the observation period. In the contents of the intervention, subjects will work out bicycle exercise performed by 50 % of VO2max for 90 minutes.
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 1.Those who obtain written consent from the subject concerning research participation.
2.The 18 to 30 years old healthy male and female.
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 15

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 2020021
Address 3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL 090-2673-0660
Email Jun1okd@waseda.jp

Public contact
Name of contact person
1st name Shota
Middle name
Last name Yamaguchi
Organization Waseda university
Division name Sport science graduate course
Zip code 2020021
Address 2-7-5 Higashifushimi, Nishitokyo city, Tokyo
TEL 08020594303
Homepage URL
Email y.shota-56@akane.waseda.jp

Sponsor
Institute Waseda univesity
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
Email 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
2019 Year 05 Month 17 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
2019 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 15 Day
Last follow-up date
2022 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
2019 Year 05 Month 17 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041911

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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