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
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
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
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
