UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036730 |
|---|---|
| Receipt number | R000041852 |
| Scientific Title | Comparative test |
| Date of disclosure of the study information | 2019/05/14 |
| Last modified on | 2019/05/13 19:05:03 |
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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
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
maruyama@med.tohoku.ac.jp
Sponsor or person
Institute
Science of Nursing Practice,Health Scicences,Tohoku University Graduation School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041852
