UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028633
Receipt No. 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 2019/05/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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 202 0021
Address 2-7-5 Higashifushimi, Nishitokyo city, Tokyo
TEL 080-2059-4303
Homepage URL
Email y.shota-56@akane.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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
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
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 No longer recruiting
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
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=R000032760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.