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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037070
Receipt No. R000042242
Scientific Title Evaluation of cough peak flow and effect of cough training on community dwelling elderly people
Date of disclosure of the study information 2019/06/14
Last modified on 2019/06/14

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Basic information
Public title Evaluation of cough peak flow and effect of cough training on community dwelling elderly people
Acronym Evaluation of cough peak flow and effect of cough training on community dwelling elderly people
Scientific Title Evaluation of cough peak flow and effect of cough training on community dwelling elderly people
Scientific Title:Acronym Evaluation of cough peak flow and effect of cough training on community dwelling elderly people
Region
Japan

Condition
Condition Community dwelling elderly people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of cough peak flow and its relation to diaphragmatic movement, also effect of cough training using peak flow meter on cough strength on community dwelling elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cough peak flow
Key secondary outcomes Pulmonary function(spirometry)
Diaphragmatic movement
Lateral abdominal muscle thickness

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 Cough training using peak flow meter, chest expansion exercise, diaphragmatic breathing exercise, abdominal muscle 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Community dwelling elderly people who participate to the health promotion class regarding cough function and give informed consent for cooperation to the survey.
Key exclusion criteria Persons who have no intention of cooperation to the survey and have physical dysfunction that may influence to outcome measures.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Kouji
Middle name
Last name Ihashi
Organization Fukushima medical university
Division name Preparing section for new faculty of medical science
Zip code 960-1295
Address 1 Hikarigaoka, Fukushima City Fukushima, 960-1295
TEL 024-547-1951
Email ihashi@fmu.ac.jp

Public contact
Name of contact person
1st name Kouji
Middle name
Last name Ihashi
Organization Fukushima Medical University
Division name Preparing section for new faculty of medical science
Zip code 960-1295
Address 1 Hikarigaoka, Fukushima City Fukushima, 960-1295
TEL 024-547-1951
Homepage URL
Email ihashi@fmu.ac.jp

Sponsor
Institute Fkushima medical university
Institute
Department

Funding Source
Organization Fukushima prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University
Address 1 Hikarigaoka, Fukushima City Fukushima, 960-1295
Tel 024-547-1825
Email rs@fmu.ac.jp

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
2019 Year 06 Month 14 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 15 Day
Date of IRB
2019 Year 04 Month 15 Day
Anticipated trial start date
2019 Year 06 Month 18 Day
Last follow-up date
2019 Year 09 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 14 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042242

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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