UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036409 |
|---|---|
| Receipt number | 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 | 2024/10/07 12:26:33 |
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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
Non-randomized
Randomization unit
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
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
yasutake@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/eiyogakuzashi/81/3/81_111/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/eiyogakuzashi/81/3/81_111/_pdf/-char/ja
Number of participants that the trial has enrolled
82
Results
Before the support period, no significant differences were found in age, body mass index , gender, and level of independence in daily life between the residents of the intervention and non-intervention facilities; furthermore, no significant difference was observed in the total number of foods consumed per day at both facilities. However, after the support period, the residents of the intervention facility consumed significantly more foods per day than those of the non-intervention facility.
Results date posted
| 2024 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age of the residents was 89.0 (85.0-92.0) years, there were 14 men and 68 women, the BMI was 20.7 (18.5-23.6) kg/m2, and 68 (82.9%) were in the stage requiring nursing care (IIIa-M) in terms of the degree of independence in daily living. No statistical differences were found in the attributes of these residents between the intervention and non-intervention facilities.
Participant flow
In this study, families (proxies) of older people residing in group homes were provided oral and written explanations regarding the study from the principal investigator and staff from each affiliated facility.
Adverse events
Nothing
Outcome measures
Changes in the number of foods consumed per day at both base-line and end-line.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | 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
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041474
