UMIN-CTR Clinical Trial

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
Email	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
Email	a-morino@chitose-reha.ac.jp

Sponsor
Institute	Hokkaido Chitose College of Rehabilitation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044775