UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Voluntary cough intensity and its influencing factors by gender in community-dwelling adults
Title of the study (Brief title)	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	Atsuhiro Tsubaki
Organization	Niigata University of health and Welfare
Division name	Institute for Human Movement and Medical Sciences
Address	1398 shimami-cho, kita-ku, Niigata-city, Niigata
TEL	025-257-4438
Email	tsubaki@nuhw.ac.jp

Public contact
Name of contact person	Atsuhiro Tsubaki
Organization	Niigata University of health and Welfare
Division name	Institute for Human Movement and Medical Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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