UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036781
Receipt number 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 2021/10/21 06:37:44

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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

08034802039

Email

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

2020021

Address

2-7-5 Higashifushimi, Nishitokyo city, Tokyo

TEL

08034802039

Homepage URL


Email

kato@yahoo.co.jp


Sponsor or person

Institute

Waseda univesity

Institute

Department

Personal name



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

11

Results

We found peak titin N-terminal fragment 5.5 h after cycling exercise.
Those results are difference from damage after eccentric exercise.

Results date posted

2020 Year 05 Month 24 Day

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

2019 Year 06 Month 30 Day

Date of IRB

2019 Year 08 Month 30 Day

Anticipated trial start date

2019 Year 06 Month 15 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 10 Month 01 Day

Date trial data considered complete

2020 Year 10 Month 01 Day

Date analysis concluded

2020 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2019 Year 05 Month 17 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=R000041911


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name