UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022869
Receipt number R000026354
Scientific Title Prevalence of exercise-induced bronchoconstriction in St.Marianna University School of Medicine students
Date of disclosure of the study information 2016/07/01
Last modified on 2016/06/24 11:20:20

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Basic information

Public title

Prevalence of exercise-induced bronchoconstriction in St.Marianna University School of Medicine students

Acronym

Exercise-induced bronchoconstriction screening in college students

Scientific Title

Prevalence of exercise-induced bronchoconstriction in St.Marianna University School of Medicine students

Scientific Title:Acronym

Exercise-induced bronchoconstriction screening in college students

Region

Japan


Condition

Condition

Exercise-induced bronchoconstriction

Classification by specialty

Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of our study is to investigate prevalence of EIB with EIB screening questionnaires and laboratory exercise challenge in St.Marianna University School of Medicine students.

Basic objectives2

Others

Basic objectives -Others

screening

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Respiratory function at before and after laboratory exercise challenge(PEF,FVC,FEV1.0,FEV1.0%(G),V50,V25)

Key secondary outcomes

Questionnaire(asthma,allergy,exercise-related symptoms,smoking,sports, e.g.)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Multistep exercise protocols for the cycle ergometer is adopted.
Started at 25W/min and increase each 25W/min per minutes.
Participants exercise for 5 minutes and keep rest for 3 minutes after exercise.
Participants undergo spirometry at before and after exercise.

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

40 years-old >

Gender

Male and Female

Key inclusion criteria

St.Marianna University School of Medicine students

Key exclusion criteria

pregnancy
recent upper-respiratory tract infection
severe cardiovascular or respiratory diseases
musculoskeletal disorders

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruki Musha

Organization

St.Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code


Address

2-16-1, Sugao, Miyamaeku, Kawasaki, Kanagawa

TEL

044-977-8111

Email

musha@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Aya Uchino

Organization

St.Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code


Address

2-16-1, Sugao, Miyamaeku, Kawasaki, Kanagawa

TEL

044-977-8111

Homepage URL


Email

a2kaneko@marianna-u.ac.jp


Sponsor or person

Institute

St.Marianna University School of Medicine
Department of Sports Medicine

Institute

Department

Personal name



Funding Source

Organization

St.Marianna University School of Medicine

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


Address


Tel


Email



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

2016 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2016 Year 03 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 24 Day

Last modified on

2016 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026354


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name