UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039259 |
|---|---|
| Receipt number | R000044775 |
| Scientific Title | Cough training in community-dwelling elderly women |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2021/01/26 10:31:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of cough training methods in community-dwelling elderly women
Acronym
Cough training in community-dwelling elderly women
Scientific Title
Cough training in community-dwelling elderly women
Scientific Title:Acronym
Cough training in community-dwelling elderly women
Region
| Japan |
Condition
Condition
community-dwelling elderly women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effective training methods to improve coughing in community-dwelling elderly women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cough peak flow
Key secondary outcomes
respiratory function
respiratory muscle strength
abdominal muscle strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cough training (60% cough peak flow, 30 times/day, 5 days/week or more, 8 weeks)
Interventions/Control_2
abdominal muscle training (30 times/day, 3 days/week or more, 8 weeks)
Interventions/Control_3
control
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
Female
Key inclusion criteria
those who aged 65 and more
Key exclusion criteria
cognitive impairment (MMSE < 21)
orthopedic disease that affect the motor function test
respiratory disease
forced expiratory volume % in one second less than 70%
history of respiratory disease within one month
Difficult to voluntarily cough
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | AKIRA |
| Middle name | |
| Last name | MORINO |
Organization
Hokkaido Chitose College of Rehabilitation
Division name
Department of Rehabilitation
Zip code
066-0055
Address
Satomi 2-10, Chitose, Hokkaido
TEL
0123285331
a-morino@chitose-reha.ac.jp
Public contact
Name of contact person
| 1st name | AKIRA |
| Middle name | |
| Last name | MORINO |
Organization
Hokkaido Chitose College of Rehabilitation
Division name
Department of Rehabilitation
Zip code
066-0055
Address
Satomi 2-10, Chitose, Hokkaido
TEL
0123285331
Homepage URL
a-morino@chitose-reha.ac.jp
Sponsor or person
Institute
Hokkaido Chitose College of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido chitose college of rehabilitation ethics committee
Address
Satomi 2-10, Chitose, Hokkaido
Tel
0123285331
rinrishinsa@chitose-reha.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
| 2020 | Year | 02 | 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
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
Suspended
Date of protocol fixation
| 2019 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 01 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044775
