UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023567 |
|---|---|
| Receipt number | 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 | 2020/02/12 10:01:04 |
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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 | Yusuke |
| Middle name | |
| Last name | Chigira |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health Science
Zip code
370-0033
Address
501 Nakaoorui, Takasakisi, Gunma 370-0033, Japan
TEL
027-352-1291
chigira@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Chigira |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health Science
Zip code
370-0033
Address
501 Nakaoorui, Takasakisi, Gunma 370-0033, Japan
TEL
027-352-1291
Homepage URL
chigira@takasaki-u.ac.jp
Sponsor or person
Institute
Department of Rehabilitation, Kan-etsu Central Hospital
Institute
Department
Personal name
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
Takasaki University of Health and Welfare
Address
501 Nakaoorui, Takasakisi, Gunma 370-0033, Japan
Tel
027-352-1291
chigira@takasaki-u.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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2016 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 12 | Day |
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
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026769
