UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023912 |
|---|---|
| Receipt number | 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 15:23:32 |
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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
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
tsubaki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027537
