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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033846
Receipt No. 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

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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
Email 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
Email 7ga01c@ruri.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038600

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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