UMIN-CTR Clinical Trial

Basic information
Public title	Verification of improvement of physical activities in elderly people using active guide
Acronym	Verification of improvement of physical activities in elderly people using active guide
Scientific Title	Verification of improvement of physical activities in elderly people using active guide
Scientific Title:Acronym	Verification of improvement of physical activities in elderly people using active guide
Region	Japan

Condition
Condition	physical activities
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify the effect of improving physical activities in elderly people using active guide.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	physical activities
Key secondary outcomes	K6

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	active guide brochure is offered.
Interventions/Control_2	active guide brochure is not offered.
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 people who can install active style pro for 9 days or more.
Key exclusion criteria	1 Elderly people with visceral disease and those who were receiving medical treatment at the time of the study. 2 Elderly people with mental illness and those who were receiving medical treatment at the time of the study. 3 Elderly people with severe motor impairment of the upper/lower extremities. 4 Other conditions that resulted in elderly people being considered to be ineligible by the researcher.
Target sample size	82

Research contact person
Name of lead principal investigator	1st name Middle name Last name owari yutaka
Organization	Shikoku medical college
Division name	Department of Judo Therapy
Zip code
Address	62-1, Hamagoban-chou Utadu-chou, Ayauta-gun, Kagawa 769-0205, Japan
TEL	0877-41-2320
Email	owari@459.ac.jp

Public contact
Name of contact person	1st name Middle name Last name owari yutaka
Organization	Shikoku medical college
Division name	Department of Judo Therapy
Zip code
Address	62-1, Hamagoban-chou Utadu-chou, Ayauta-gun, Kagawa 769-0205, Japan
TEL	0877-41-2320
Homepage URL	http://www.459.ac.jp/
Email	owari@459.ac.jp

Sponsor
Institute	shikoku medical college
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization
Address
Tel
Email

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	四国医療専門学校（香川県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 16 Day

Related information
URL releasing protocol	http://www.459.ac.jp/
Publication of results	Unpublished

Result
URL related to results and publications	http://www.459.ac.jp/
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	2017 Year 06 Month 09 Day
Date of IRB	2017 Year 04 Month 05 Day
Anticipated trial start date	2017 Year 06 Month 16 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 06 Month 16 Day
Last modified on	2020 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031840