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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036730
Receipt No. R000041852
Scientific Title Comparative test
Date of disclosure of the study information 2019/05/14
Last modified on 2019/05/13

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Basic information
Public title Effects of Physical activity on cognitive function and physical functions among older people with dementia living in group homes in Japan
Acronym Comparative test
Scientific Title Comparative test
Scientific Title:Acronym Comparative test
Region
Japan

Condition
Condition Dementia
Classification by specialty
Nursing Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to concurrently and objectively measure, using a modern pedometer ,the day time levels of physical activity over 7 days period ,and to clarify the effects of physical activity on cognitive function and physical functions (heart rate, blood pressure) among older people with dementia living in group homes in Japan.
Basic objectives2 Others
Basic objectives -Others This study aimed to concurrently and objectively measure, using a modern pedometer ,the day time levels of physical activity over 7 days period ,and to clarify the effects of physical activity on cognitive function and physical functions (heart rate, blood pressure) among older people with dementia living in group homes in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical activity,cognitive function
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 men and women who are diagnosed with dementia and who are able to walk on their own in group homes
Key exclusion criteria (1) When the family and the person refuse research cooperation.
(2) When it is judged that it is difficult to obtain the communication necessary to carry out research by collating with the level of cognitive function
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ryoko
Middle name
Last name Maruyama
Organization Health Scicences,Tohoku University Graduation School of Medicine
Division name Science of Nursing Practice
Zip code 980-8575
Address 2-1,Seiryo-machi,Aoba-ku,Sendai,Japan
TEL 022-717-7484
Email maruyama@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Ryoko
Middle name
Last name Maruyama
Organization Health Scicences,Tohoku University Graduation School of Medicine
Division name Science of Nursing Practice
Zip code 980-8575
Address 2-1,Seiryo-machi,Aoba-ku,Sendai,Japan
TEL 022-717-7484
Homepage URL
Email maruyama@med.tohoku.ac.jp

Sponsor
Institute Science of Nursing Practice,Health Scicences,Tohoku University Graduation School of Medicine
Institute
Department

Funding Source
Organization Science of Nursing Practice,Health Scicences,Tohoku University Graduation School of Medicine
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 Health Scicences,Tohoku University Graduation School of Medicine
Address 2-1,Seiryo-machi,Aoba-ku,Sendai,Japan
Tel 022-717-7484
Email maruyama@med.tohoku.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
2019 Year 05 Month 14 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 05 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Physical activity, Cognitive function

Management information
Registered date
2019 Year 05 Month 13 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041852

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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