UMIN-CTR Clinical Trial

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
Email	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
Email	hkaneko@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036153