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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027781
Receipt No. R000031840
Scientific Title Verification of improvement of physical activities in elderly people using active guide
Date of disclosure of the study information 2017/06/16
Last modified on 2018/06/18

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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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 09 Day
Date of IRB
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
2018 Year 06 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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