UMIN-CTR Clinical Trial

Basic information
Public title	Effects of regular participation in community salons on mental and physical functions of community-dwelling older adults.
Acronym	Effects of participation in community salons on mental and physical functions of elders.
Scientific Title	Effects of regular participation in community salons on mental and physical functions of community-dwelling older adults.
Scientific Title:Acronym	Effects of participation in community salons on mental and physical functions of elders.
Region	Japan

Condition
Condition	Adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effects of regular participant for community salons on mental and physical functions in community-dwelling elders.
Basic objectives2	Others
Basic objectives -Others	To investigate incident of frailty in community elders.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To implement the following assessments once a year for three years: The 25 items basic checklist to determine frail elderly people, Timed Up and Go test, 30s chair stand test, sit and reach test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention is exercise instruction for 45 minutes per month for 3 years.
Interventions/Control_2	Controls.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Regional elderly in which activities of daily living is independent.
Key exclusion criteria	Those who have received nursing care certification.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Katsuhiko Middle name Last name Takatori
Organization	Kio University
Division name	Department of Physical Therapy
Zip code	6300137
Address	4-2-2 Umami-naka, Koryo-cho, KIta-katsuragi-gun ,Nara, Japan
TEL	0745541601
Email	k.takatori@kio.ac.jp

Public contact
Name of contact person	1st name Katsuhiko Middle name Last name Takatori
Organization	Kio University
Division name	Department of Physical Therapy
Zip code	6300137
Address	4-2-2 Umami-naka, Koryo-cho, KIta-katsuragi-gun ,Nara, Japan
TEL	0745541601
Homepage URL
Email	k.takatori@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kio University
Address	4-2-2 Umami-naka, Koryo-cho, KIta-katsuragi-gun ,Nara, Japan
Tel	0745541601
Email	k.takatori@kio.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	2017 Year 01 Month 12 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://doi.org/10.15063/rigaku.11463
Number of participants that the trial has enrolled	294
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 05 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2023 Year 03 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	2017 Year 01 Month 11 Day
Last modified on	2022 Year 07 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029477