UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051941 |
|---|---|
| Receipt number | R000059272 |
| Scientific Title | A Large-scale Longitudinal Cohort Study to MaintainWell-Being and Functioning in Middle and Elderly Adults |
| Date of disclosure of the study information | 2023/08/19 |
| Last modified on | 2023/08/19 15:54:58 |
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Basic information
Public title
A Large-scale Longitudinal Cohort Study to MaintainWell-Being and Functioning in Middle and Elderly Adults
Acronym
A Large-scale Longitudinal Cohort Study to MaintainWell-Being and Functioning in Middle and Elderly Adults
Scientific Title
A Large-scale Longitudinal Cohort Study to MaintainWell-Being and Functioning in Middle and Elderly Adults
Scientific Title:Acronym
A Large-scale Longitudinal Cohort Study to MaintainWell-Being and Functioning in Middle and Elderly Adults
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to elucidate the relationship between various diseases and the need for nursing care by conducting a long-term survey of middle-aged and elderly adults (45-89 years old) on items such as exercise, nutrition, sleep, and social activities from middle age onward.
Basic objectives2
Others
Basic objectives -Others
Cohort study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function, sleep status, mental and physical status, physical function, social network, nursing care classification
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Health and Lifestyle Survey for Tsukuba Citizens: Tsukuba City residents aged 45 to 89 years old
2)Tsukuba Happiness Life Health Examination
(1)Persons who have given consent to participate in this study
(2)Those who have participated in either the "Health and Life Survey for Tsukuba Citizens" or the "Human Health Checkup" at the Research Center for Preventive Medicine, University of Tsukuba Hospital, and meet one of the following conditions: i) to iv)
i)Those prone to cognitive decline: Picked up in the order of their Everyday Cognition scores from the highest (worst) to the highest (best).
ii)Those who tend to have sleep disorder: Pick up those in order of their scores on the Athens Insomnia Scale from the highest (lowest) to the highest (highest).
iii)Those who tend to have decreased life function:
[45-59 years old]: Those who answered, stroke aftereffects, cardiac disease or musculoskeletal disease in the current medical history on the mail survey form
[60-89 years old]: (A)Those who answered, Sequelae of stroke, cardiac disease or musculoskeletal disease in the current medical history on the mail survey form
(B)Those who answered "No" in the current medical history on the mail survey form(Q52) Have you lost 2 to 3 kg or more in the last 6 months?
(C)(Q104) Do you walk continuously for about 15 minutes?
Those who answered at least one of (A), (B) and (C).
iv)Normal subjects: Those who do not fall into any of the categories from i to iii (The scores of the items from i to iii were converted into standard scores, and the subjects were selected from the order of the highest total score).
3)Those who can come to the venue (Preventive Medicine Research Center of University of Tsukuba Hospital) by themselves.
Key exclusion criteria
1) Persons who could not give consent to participate in this study
2) Those who are unable to confirm their own will due to dementia or other reasons
3) Persons who are judged by the principal investigator to be unsuitable to participate in this study
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | OKURA |
Organization
University of Tsukuba
Division name
Institute of Health and Sport Sciences
Zip code
305-8577
Address
1-2 Tennodai Tsukuba
TEL
029-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | YOON |
| Middle name | |
| Last name | Jieun |
Organization
Institute of Health and Sport Sciences
Division name
Institute of Health and Sport Sciences
Zip code
305-8577
Address
1-2 Tennodai Tsukuba
TEL
029-859-1593
Homepage URL
https://tsukubadigitalbio.jp/info/504/
yoon.jieun.fu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
2-1-1, Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
| 2023 | Year | 08 | Month | 19 | 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
10000
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations
(1) Basic information: date of birth, sex, status of support and nursing care required, current medical history, family situation, smoking and drinking habits, financial status, educational history, work status
(2) Infectious diseases: medical history, vaccination history, antibody testing history
(3) Cognitive function (Memory): Everyday Cognition, memory complaints
(4) Sleep quality: Pittsburgh Sleep Quality Index, Athens Insomnia Scale
(5) Physical funtion: height, weight, dental condition
(6) Social network
(7) Mood: subjective wellneing, depression
(8) Living environment: International Physical Activity Questionnaire Environmental Module
(9) Sports
(10) Stress
(11) Daily life: Basic checklist, TMIG-IC (TMIG-IC)
etc.
Management information
Registered date
| 2023 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059272
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
