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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036282
Receipt No. R000041325
Scientific Title Effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults
Date of disclosure of the study information 2019/04/01
Last modified on 2020/05/14

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Basic information
Public title Effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults
Acronym Effect of inspiratory muscle training in frail older adults
Scientific Title Effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults
Scientific Title:Acronym Effect of inspiratory muscle training in frail older adults
Region
Japan

Condition
Condition Frail older adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of inspiratory muscle training on respiratory function,balance function,and exercise tolerance in frail older adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Respiratory muscle strength
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Inspiratory muscle training(30 repetitions per day,at least 5 days per week,for 4 weeks)
Interventions/Control_2 No intervention
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 1.Persons who are using "Medical corporation Yamato Seishinkai Geriatric health services facility Shobuen day care services "
2.Persons who can acquire the consent of research participation,from his/her and family
3.Persons certified in long-term care insurance(at least 65years old)
4.Persons who exist muscle weakness(grip strength: male <26 kg, female <18 kg), physical function deterioration(normal walking speed <=1.0 m/sec)
5.Persons corresponding to either one of the two items of weight loss and fatigue based on J-CHS
Key exclusion criteria 1.Persons who cannot conduct inspection / measurement
2.Persons who have a FEV1.0% less than 70%
3.Persons who has serious heart disease
4.Persons who has pneumothorax in past medical history
5.Persons who have poor control for pain at the time of examination
6.Persons who cannot follow the indicated action due to dementia or psychiatric symptoms
7.Persons who cannot obtain consent for this research
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hideo
Middle name
Last name Kaneko
Organization International University of Health and Welfare
Division name School of Health Sciences at Fukuoka
Zip code 831-0004
Address 137-1 Enokizu,Okawa-shi,Fukuoka,Japan
TEL 0944-89-2000
Email hkaneko@iuhw.ac.jp

Public contact
Name of contact person
1st name Suguru
Middle name
Last name Nonaka
Organization Medical Corporation Yamato Seishinkai Fujioka Hospital
Division name Department of Rehabilitation
Zip code 840-0201
Address 2685 Niiji,Yamato-cho,Saga-shi,Saga,Japan
TEL 0952-62-2200
Homepage URL
Email 18S1134@g.iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization International University of Health and Welfare,Institutional Review Board
Address 137-1 Enokizu,Okawa-shi,Fukuoka,Japan
Tel 0944-89-2031
Email oocamp@iuhw.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 04 Month 01 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 15
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
2019 Year 03 Month 31 Day
Date of IRB
2018 Year 12 Month 25 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 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 03 Month 24 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041325

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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