UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055537 |
|---|---|
| Receipt number | R000063422 |
| Scientific Title | China Elderly Data of Exercise Health |
| Date of disclosure of the study information | 2024/09/19 |
| Last modified on | 2024/09/18 23:34:03 |
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Basic information
Public title
China Elderly Data of Exercise Health
Acronym
CEDEH
Scientific Title
China Elderly Data of Exercise Health
Scientific Title:Acronym
CEDEH
Region
| Asia(except Japan) |
Condition
Condition
Open public recruiting
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the relationship between physical activity and physical health, aging and disease during natural ageing in a Chinese population, and to conduct a quantitative and qualitative study of the relationship between exercise dose and health benefits in older adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploring the relationship between physical activity and physical health, aging and disease in the natural aging process of Chinese older adults and the effective dose of exercise to enhance physical health and improve chronic disease.
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged over 60 years, voluntary participation in the study, provision of informed consent.
Key exclusion criteria
Participation who are unable to participate properly due to physical limitations or communicate with researchers, etc. and inability to provide informed consent.
Target sample size
13000000
Research contact person
Name of lead principal investigator
| 1st name | Qi |
| Middle name | |
| Last name | Guo |
Organization
Shanghai University of Medicine and Health Sciences
Division name
China
Zip code
201318
Address
279 Zhouzhu highway , Pudong New District, Shanghai
TEL
15620467578
guoqijp@gmail.com
Public contact
Name of contact person
| 1st name | Xiaoyu |
| Middle name | |
| Last name | Chen |
Organization
Shanghai University of Medicine and Health Sciences
Division name
China
Zip code
201318
Address
279 Zhouzhu highway , Pudong New District, Shanghai
TEL
18822002275
Homepage URL
1334427886@qq.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shanghai University of Medicine and Health Sciences
Address
279 Zhouzhu highway , Pudong New District, Shanghai
Tel
15620467578
guoqijp@gmail.com
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
Shanghai University of Medicine and Health Sciences
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All participants were invited to a face-to-face interview to answer a standardized questionnaire. Baseline date of sociodemographic characteristics, health behaviors, condition of chronic diseases were considered as covariates. Demographic characteristics included age, gender, weight, education level. Health behaviors included smoking and drinking habits. Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ). Cognitive assessment was completed using the Mini-Mental State Examination (MMSE) by trained investigators. It includes 30 items, the score ranges from 0 to 30 points, with the higher scores indicating better cognitive performance. The use of MMSE to define MCI is consistent with previous studies, that is, The cut-off points used for cognitive impairment were as follow: less than 17 for illiterate people, less than 20 for people with primary school, and less than 24 for people with middle school or higher. The above cut-off points have been proved to be sensitive and effective in the diagnosis of MCI in Chinese elderly population. The daily activity ability was evaluated using the Instrumental Activities of Daily Living scale (IADL).
Management information
Registered date
| 2024 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063422
