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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023567
Receipt No. R000026769
Scientific Title Effect of breath strength training in Elderly Including the intervention by electrical stimulation
Date of disclosure of the study information 2016/08/22
Last modified on 2016/08/09

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Basic information
Public title Effect of breath strength training in Elderly
Including the intervention by electrical stimulation
Acronym Effect of breath strength training in Elderly
Scientific Title Effect of breath strength training in Elderly
Including the intervention by electrical stimulation
Scientific Title:Acronym Effect of breath strength training in Elderly
Region
Japan

Condition
Condition Elderly
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of breath strength training in Elderly
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Respiratory function
Respiratory muscle strength

Key secondary outcomes

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
Other
Interventions/Control_1 Expiratory muscle strength training
2-3/week
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
100 years-old >
Gender Male and Female
Key inclusion criteria 1.without respiratory disease
1.65 years of age or older
Key exclusion criteria Dementia
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke chigira
Organization Takasaki University of Health and Welfare
Division name Faculty of Health Science
Zip code
Address 501 Nakaoorui, Takasakisi, Gunma 370-0033, Japan
TEL 027-352-1291
Email chigira@takasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke chigira
Organization Takasaki University of Health and Welfare
Division name Faculty of Health Science
Zip code
Address 501 Nakaoorui, Takasakisi, Gunma 370-0033, Japan
TEL 027-352-1291
Homepage URL
Email chigira@takasaki-u.ac.jp

Sponsor
Institute Department of Rehabilitation, Kan-etsu Central Hospital
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
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 関越中央病院

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 22 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
2016 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 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 08 Month 09 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026769

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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