UMIN-CTR Clinical Trial

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
Last 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
1st 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