UMIN-CTR Clinical Trial

Basic information
Public title	The effect of an exercise program at incorporates Kagura movements for residents
Acronym	The effect of an exercise program at incorporates Kagura movements for residents
Scientific Title	The effect of an exercise program at incorporates Kagura movements for residents
Scientific Title:Acronym	The effect of an exercise program at incorporates Kagura movements for residents
Region	Japan

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

Objectives
Narrative objectives1	This study aims to examine the effect of an exercise program that incorporates the movements of Kagura on the physical function, muscle strength, and behavioral change of the inhabitants.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in physical function, muscular strength, and awareness, attitude, and behavior toward exercise
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Ten types of exercises that incorporate the movements of Kagura
Interventions/Control_2	Ten types of exercises that incorporate the movements of Kagura
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Survey area residents who are 20 years of age or older at the time of obtaining consent 2.Those who have no exercise restrictions 3.Those who do not usually exercise 4.Residents who received sufficient explanation before participating in this study, and after obtaining adequate understanding, obtained the written consent of the person himself/herself.
Key exclusion criteria	1.Minors 2.Persons with exercise restrictions due to illness, etc. 3.Those who have regular exercise habits at least once a week 4.Other subjects which the person in charge of implementation deems inappropriate as research subjects
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shuji Middle name Last name TAKAHASHI
Organization	Miyazaki Prefectural Nursing University
Division name	Faculty of Nursing
Zip code	880-0929
Address	3-5-1 Manabino, Miyazaki city, Miyazaki
TEL	0985597700
Email	s-taka@mpu.ac.jp

Public contact
Name of contact person	1st name Shuji Middle name Last name TAKAHASHI
Organization	Miyazaki Prefectural Nursing University
Division name	Faculty of Nursing
Zip code	880-0929
Address	3-5-1 Manabino, Miyazaki city, Miyazaki
TEL	0985-59-7700
Homepage URL
Email	s-taka@mpu.ac.jp

Sponsor
Institute	Miyazaki Prefectural Nursing University
Institute
Department

Funding Source
Organization	Miyazaki Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Miyazaki Prefectural Nursing University Research Ethics Committee
Address	3-5-1 Manabino, Miyazaki city, Miyazaki
Tel	0985-59-7700
Email	i-rinri@mpu.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	2021 Year 06 Month 13 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	Completed
Date of protocol fixation	2020 Year 03 Month 15 Day
Date of IRB	2020 Year 03 Month 10 Day
Anticipated trial start date	2021 Year 06 Month 13 Day
Last follow-up date	2022 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	2021 Year 06 Month 08 Day
Last modified on	2022 Year 08 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050801