UMIN-CTR Clinical Trial

Basic information
Public title	A study on improvement of respiratory function in the elderly living at home
Acronym	A study on improvement of respiratory function in the elderly living at home
Scientific Title	A study on improvement of respiratory function in the elderly living at home
Scientific Title:Acronym	A study on improvement of respiratory function in the elderly living at home
Region	Japan

Condition
Condition	Elderly living at home
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The necessity of maintaining and improving respiratory function for elderly people living in the community to prevent aspiration is confirmed, and the respiratory function improvement program for preventing aspiration from an early stage and its effect are verified.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcomes will be measured by (1) respiratory function measurements. Evaluations are made immediately before the respiratory function improvement program and three months after the intervention.
Key secondary outcomes	Primary outcomes will be measured by (2) self-administered questionnaire surveys, etc. Evaluations are made immediately before the respiratory function improvement program and three months after the intervention.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	A (+) intervention group Preventive intervention with respiratory function improvement program Conduct place: Home and salon B Control group (no intervention)
Interventions/Control_2
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	Elderly living at home People without dementia
Key exclusion criteria	dementia
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takemi Middle name Last name Matsuda
Organization	Faculty of nursing, Chubu Gakuin University
Division name	Faculty of Human Welfare
Zip code	501-3993
Address	2-1 Kirigaoka, Seki City, Gifu Prefecture
TEL	0575-24-2211
Email	matsuda-takemi@chubu-gu.ac.jp

Public contact
Name of contact person	1st name Takemi Middle name Last name Matsuda
Organization	University of Human Environments
Division name	Graduate School of Nursing
Zip code	474-0035
Address	3-220 Ebata-cho, Obu City, Aichi Prefecture
TEL	0562-43-0701
Homepage URL
Email	dn17008@uhe.ac.jp

Sponsor
Institute	Faculty of nursing, Chubu Gakuin University
Institute
Department

Funding Source
Organization	Faculty of nursing, Chubu Gakuin University
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	University of Human Environments
Address	3-220 Ebata-cho, Obu City, Aichi Prefecture
Tel	0575-24-2211
Email	dn17008@uhe.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 03 Month 28 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	25
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	No longer recruiting
Date of protocol fixation	2018 Year 10 Month 30 Day
Date of IRB	2018 Year 10 Month 30 Day
Anticipated trial start date	2020 Year 03 Month 28 Day
Last follow-up date	2020 Year 08 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 03 Month 25 Day
Last modified on	2020 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045543