UMIN-CTR Clinical Trial

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