UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023283
Receipt No. R000026827
Scientific Title Study on Effect of Multimodal Dementia Prevention Program in Community- Dwelling Elderly
Date of disclosure of the study information 2016/09/01
Last modified on 2021/05/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Acronym Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Scientific Title Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Scientific Title:Acronym Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Region
Japan

Condition
Condition healthy community-dwelling elderly
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether dementia prevention exercise is associated with a reduced risk for dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mini mental state examination
Key secondary outcomes CFI, EQ-5D, Five Cog, Timed Up & Go test, Physical Activity Scale for the Elderly and Geriatric Depression Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Group1: intensive training and booster training group
intensive training: once a week for 10 weeks
booster training: once every 3 months
training: physical exercise, dual task training, cognitive exercise, nutritional guidance
Interventions/Control_2 Group2: intensive training group
intensive training: once a week for 10 weeks
no booster training
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria healthy community-dwelling elderly
Key exclusion criteria people with dementia
walking difficulty
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Kajita
Organization Kobegakuin university
Division name Faculty of rehabilitation
Zip code 6512180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL 078-974-1551
Email kajita@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Kajita
Organization Kobegakuin university
Division name Faculty of rehabilitation
Zip code 6512180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL 078-974-1551
Homepage URL
Email kajita@reha.kobegakuin.ac.jp

Sponsor
Institute Faculty of rehabilitation, Kobegakuin university
Institute
Department

Funding Source
Organization World Health Organizati
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kobe university
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobegakuin university
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
Tel 0789741551
Email kajita@reha.kobegakuin.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
2016 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
2017 Year 02 Month 02 Day
Anticipated trial start date
2017 Year 08 Month 01 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

Management information
Registered date
2016 Year 07 Month 22 Day
Last modified on
2021 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026827

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.