UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevalence of exercise-induced bronchoconstriction in St.Marianna University School of Medicine students
Title of the study (Brief title)	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.)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Haruki Musha
Organization	St.Marianna University School of Medicine
Division name	Department of Sports Medicine
Address	2-16-1, Sugao, Miyamaeku, Kawasaki, Kanagawa
TEL	044-977-8111
Email	musha@marianna-u.ac.jp

Public contact
Name of contact person	Aya Uchino
Organization	St.Marianna University School of Medicine
Division name	Department of Sports Medicine
Address	2-16-1, Sugao, Miyamaeku, Kawasaki, Kanagawa
TEL	044-977-8111
Homepage URL
Email	a2kaneko@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine Department of Sports Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026354