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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023912
Receipt No. R000027537
Scientific Title Voluntary cough intensity and its influencing factors by gender in community-dwelling adults
Date of disclosure of the study information 2016/09/05
Last modified on 2016/09/02

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Basic information
Public title Voluntary cough intensity and its influencing factors by gender in community-dwelling adults
Acronym Gender differences in voluntary cough
Scientific Title Voluntary cough intensity and its influencing factors by gender in community-dwelling adults
Scientific Title:Acronym Gender differences in voluntary cough
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the voluntary cough strength in either gender in community-dwelling adults
Basic objectives2 Others
Basic objectives -Others To determine the factors affecting voluntary cough strength in either gender in community-dwelling adults
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes voluntary cough, respiratory function, respiratory muscle strength, grip strength, thoracic expansion
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria healthy individual
Key exclusion criteria abnormality in respiratory function, smoker
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Tsubaki
Organization Niigata University of health and Welfare
Division name Institute for Human Movement and Medical Sciences
Zip code
Address 1398 shimami-cho, kita-ku, Niigata-city, Niigata
TEL 025-257-4438
Email tsubaki@nuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuhiro Tsubaki
Organization Niigata University of health and Welfare
Division name Institute for Human Movement and Medical Sciences
Zip code
Address 1398 shimami-cho, kita-ku, Niigata-city, Niigata
TEL 025-257-4438
Homepage URL
Email tsubaki@nuhw.ac.jp

Sponsor
Institute Niigata University of health and Welfare
Institute
Department

Funding Source
Organization Niigata University of health and Welfare
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 09 Month 05 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
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 Completed
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 10 Month 31 Day
Date analysis concluded
2016 Year 02 Month 28 Day

Other
Other related information Two-hundred-and-three non-smoking community-dwelling adults (102 men, age: 49.6 +/- 20.2 years; 101 women, age: 51.4 +/- 18.4 years) were participated.

Management information
Registered date
2016 Year 09 Month 02 Day
Last modified on
2016 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027537

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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