UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of the multi-domain intervention on cognitive function among community-dwelling older adults
Title of the study (Brief title)	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	Katsuhiko Suzuki
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL	0429476898
Email	katsu.suzu@waseda.jp

Public contact
Name of contact person	Yuta Nemoto
Organization	Waseda University
Division name	Graduate School of Sport Sciences
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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