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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036409
Receipt No. R000041474
Scientific Title Nutritional and exercise physiological assessment that contributes to prevent the progress of malnutrition and sarcopenia for elderly people with dementia living in nursing homes
Date of disclosure of the study information 2019/04/05
Last modified on 2020/10/05

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Basic information
Public title Nutritional and exercise physiological assessment that contributes to prevent the progress of malnutrition and sarcopenia for elderly people with dementia living in nursing homes
Acronym Nutritional and exercise physiological assessment for elderly people with dementia
Scientific Title Nutritional and exercise physiological assessment that contributes to prevent the progress of malnutrition and sarcopenia for elderly people with dementia living in nursing homes
Scientific Title:Acronym Nutritional and exercise physiological assessment for elderly people with dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Neurology Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effects of nutritional and exercise-physiological interventions on elderly people with dementia who live in nursing homes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in nutritional status at both base-line and end-line.
Key secondary outcomes Changes in physical activity and fitness at both base-line and end-line.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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
Food Behavior,custom
Interventions/Control_1 We offer menu and cooking advice, joint cooking with the target person, exercise advice, etc. to the intervention group once a week.
Interventions/Control_2 We don't offer any intervention to the control group.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Target elderly people living in 5 Dementia Nursing homes which are research collaboration facilities, and can obtain research consent from a representative
Key exclusion criteria Those who cannot obtain the consent of the client
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kenichiro
Middle name
Last name Yasutake
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 8140198
Address 5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL 092-851-2531
Email yasutake@nakamura-u.ac.jp

Public contact
Name of contact person
1st name Kenichiro
Middle name
Last name Yasutake
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 8140198
Address 5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL 092-851-2531
Homepage URL
Email yasutake@nakamura-u.ac.jp

Sponsor
Institute Nakamura Gakuen University
Institute
Department

Funding Source
Organization Nakamura Gakuen University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nakamura Gakuen University
Address Faculty of Nutritional Sciences
Tel 092-851-2531
Email yasutake@nakamura-u.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
2019 Year 04 Month 05 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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 12 Day
Date of IRB
2019 Year 03 Month 30 Day
Anticipated trial start date
2019 Year 04 Month 22 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 04 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041474

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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