UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036282 |
|---|---|
| Receipt number | 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 23:22:02 |
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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
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
18S1134@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041325
