UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031656 |
|---|---|
| Receipt number | R000036153 |
| Scientific Title | Identification of the reduced cough capacity factor and effective interventions to improve cough capacity in community-dwelling older adults |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2020/09/09 10:16:51 |
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Basic information
Public title
Identification of the reduced cough capacity factor and effective interventions to improve cough capacity in community-dwelling older adults
Acronym
Effective interventions to improve cough capacity in older adults
Scientific Title
Identification of the reduced cough capacity factor and effective interventions to improve cough capacity in community-dwelling older adults
Scientific Title:Acronym
Effective interventions to improve cough capacity in older adults
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify effective interventions to improve cough capacity in community-dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cough peak flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Respiratory muscle training (25 repetitions per day, 5 days per week, for 4 weeks)
Interventions/Control_2
Cough training (25 repetitions per day, 5 days per week, for 4 weeks)
Interventions/Control_3
No intervention
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
Community-dwelling ambulatory older adults
Key exclusion criteria
Older adults with physical dysfunction that may influence outcome measures
Target sample size
60
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
831-8501
Address
137-1 Enokizu, Okawa-shi, Fukuoka, Japan
TEL
0944-89-2000
hkaneko@iuhw.ac.jp
Public contact
Name of contact person
| 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
831-8501
Address
137-1 Enokizu, Okawa-shi, Fukuoka, Japan
TEL
0944-89-2000
Homepage URL
hkaneko@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
International University of Health and Welfare
Address
139-7 Enokizu, Okawa-shi, Fukuoka, Japan
Tel
0944-89-2000
q-rinri@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
| 2018 | Year | 05 | 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
60
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036153
