UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033846 |
|---|---|
| Receipt number | R000038600 |
| Scientific Title | The effects of the multi-domain intervention on cognitive function among community-dwelling older adults |
| Date of disclosure of the study information | 2018/08/21 |
| Last modified on | 2019/01/23 08:26:44 |
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Basic information
Public title
The effects of the multi-domain intervention on cognitive function among community-dwelling older adults
Acronym
The effects of the multi-domain intervention on cognitive function
Scientific Title
The effects of the multi-domain intervention on cognitive function among community-dwelling older adults
Scientific Title:Acronym
The effects of the multi-domain intervention on cognitive function
Region
| Japan |
Condition
Condition
cognitive decline, dementia
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of the multi-domain intervention which focus on physical activity and social participation among community-dwelling older adults with subjective cognitive complaints.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Montreal Cognitive Assessment (MoCA-J)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group receive the lecture about the prevention of dementia. After that, participants receive the Nordic walking poles and instructions about how to use them properly.
Additionally, participants in the intervention group receive the programs consist of physical activity and exchange program (e.g. hobby, handcraft, cognitive training) once a week for ten weeks.
Interventions/Control_2
control groups receive the lecture about the prevention of dementia. After that, participants receive the Nordic walking poles and instructions about how to use them properly.
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
Having subjective cognitive complaints
Key exclusion criteria
Limited on the exercise by the doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Suzuki |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
0429476898
katsu.suzu@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Nemoto |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
0429476898
Homepage URL
7ga01c@ruri.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 08 | Month | 21 | 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
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 22 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 22 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038600
