UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018401 |
|---|---|
| Receipt number | R000021295 |
| Scientific Title | Non-randomized study to increase physical activity and prevent cognitive decline among community-dwelling elderly. Community-wide intervention including group-based non-supervised exercise. |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2023/03/09 15:12:10 |
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Basic information
Public title
Non-randomized study to increase physical activity and prevent cognitive decline among community-dwelling elderly. Community-wide intervention including group-based non-supervised exercise.
Acronym
Non-randomized study to increase physical activity and prevent cognitive decline among community-dwelling elderly
Scientific Title
Non-randomized study to increase physical activity and prevent cognitive decline among community-dwelling elderly. Community-wide intervention including group-based non-supervised exercise.
Scientific Title:Acronym
Non-randomized study to increase physical activity and prevent cognitive decline among community-dwelling elderly
Region
| Japan |
Condition
Condition
Physical inactivity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of community-wide promotion on increase of physical activity and decrease of cognitive decline among community-dwelling elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity obtained by accelerometer and questionnare, cognitive function obtained by CADi2 (Cognitive Assessment for Dementia, iPad version 2)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Control group:
For 1 year, residents in the control group live as usual.
Interventions/Control_2
Intervention group: Do group-based non-supervised physical activity at least once a week. Individual participants increase daily physical activity based on Japanese physical activity guideline.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-based small groups who do and/or will do group-based, non-supervised exercise at least once a week.
Key exclusion criteria
Patients with dementia.
People with disabilities, who report any limitations in activity due to chronic conditions.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Graduate School of Health Management, Sports Medicine Research Center
Zip code
2230061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
0455661090
yoguma@keio.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Graduate School of Health Management, Sports Medicine Research Center
Zip code
2230061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-566-1090
Homepage URL
http://f-plusten.com/
yoguma@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Graduate School of Health Management, Keio University
Address
4411 Endo, Fujisawa, Kanagawa
Tel
0466-49-6265
nmc-hm@adst.keio.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
| 2015 | Year | 07 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.ypmed.2021.106708
Number of participants that the trial has enrolled
1425
Results
Physical activity was significantly higher at the five-year follow-up than at baseline and at the two-year follow-up. The results of the multivariate analysis indicated that physical activity among older adults the primary target population of the community-wide intervention increased significantly at the five-year follow-up, compared to those aged 20 to 64.
Results date posted
| 2023 | Year | 03 | Month | 09 | Day |
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
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021295
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/08/09 | 研究計画書20160809修正.docx |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
