UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056406 |
|---|---|
| Receipt number | R000064444 |
| Scientific Title | Shanghai Ageing Population Health Management Cohort Study |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/12/09 16:36:21 |
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Basic information
Public title
Shanghai Ageing Population Health Management Cohort Study
Acronym
SAPHMC
Scientific Title
Shanghai Ageing Population Health Management Cohort Study
Scientific Title:Acronym
SAPHMC
Region
| Asia(except Japan) |
Condition
Condition
Open public recruiting
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to explore the correlation between physical performance and nutrition, quality of life, psychological status, cognitive status and mortality in older adults.
Basic objectives2
Others
Basic objectives -Others
The aim of this study was to explore the correlation between physical performance and nutrition, quality of life, psychological status, cognitive status and mortality in older adults.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of this study was to investigate the association between muscle mass, muscle strength as well as physical performance with all-cause mortality in older adults.
Key secondary outcomes
This study was to explore the association between physical performance (such as sarcopenia) with depression, cognitive impairment, quality of life in older adults.
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
Individuals who were over 60 years old and provided informed consent..
Key exclusion criteria
unable to communicate with the study staff or provide informed consent; had a severe hearing impairment or blindness; had a known diagnosis of dementia.
Target sample size
5000
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
18961062323
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
National Natural Science Foundation of China
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
China
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Relationships between sarcopenia, depressive symptoms, and mild cognitive impairment in Chinese comm
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0165032721002019?via%3Dihub
Number of participants that the trial has enrolled
1394
Results
Our findings suggest that sarcopenia may contribute substantially to the development of MCI in the older adults via depressive symptoms, although the
reverse may also be true. These findings may help guide clinicians to better diagnose and manage MCI in the context of concomitant sarcopenia and depressive
symptoms.
Results date posted
| 2024 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
We interviewed all individuals using questionnaire from our previous
study (Zhang et al., 2014). Data on socio-demographic variables
including age, gender, marital status, educational level, and occupation.
Behavioral characteristics consisted of drinking, smoking, sleep duration,
and fall history. We used the short form of the International
Physical Activity Questionnaire (IPAQ) (Bassett, 2003) to assess physical
activity. Nutrition was evaluated by the Mini Nutritional Assessment -
Short Form (MNA- SF), a validated screening tool used in geriatric
health care (Kaiser et al., 2009). In addition, we also reviewed whether
participants had chronic medical conditions, such as diabetes mellitus,
hypertension, hyperlipidemia, coronary heart disease, stroke, kidney
disease, biliary tract disease, peptic ulcer, pulmonary disease, osteoarthritis, Parkinson disease, gout, cancer and thyroid disease. Number of medications also were assessed.
Participant flow
The final analytic sample consisted of 1394 participants (men
574, women 820) after excluding 93 subjects. 6 were unable to perform
the handgrip strength test because of upper limbs disability or injury,
and 12 were unable to measure the gait speed and body composition
since they were dependent on wheelchairs; 32 participants refused to
participant in body composition or physical activity assessment due to
personal reasons; Additional 36 participants had missing data on covariates
or outcomes and 7 were diagnosed of dementia.
Adverse events
No
Outcome measures
Sarcopenia was defined according to the Asian Working Group for Sarcopenia (AWGS) criteria. Depressive symptoms were evaluated by the 30-item Geriatric Depression Scale (GDS). Cognitive function was assessed by Mini-Mental State Examination (MMSE), the Chinese version of the Dementia Rating Scale (CDRS) was used to apply the diagnostic of non-dementia, and instrument activities of daily living (IADL) were used to evaluate daily living activities.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We interviewed all individuals using questionnaire from our previous
study. Data on socio-demographic variables including age, gender, marital status, educational level, and occupation.
Behavioral characteristics consisted of drinking, smoking, sleep duration,
and fall history. We used the short form of the International Physical Activity Questionnaire (IPAQ) to assess physical activity. Nutrition was evaluated by the Mini Nutritional Assessment -Short Form (MNA- SF), a validated screening tool used in geriatric health care. In addition, we also reviewed whether participants had chronic medical conditions, such as diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease, stroke, kidney disease, biliary tract disease, peptic ulcer, pulmonary disease, osteoarthritis, Parkinson disease, gout, cancer and thyroid disease. Number of medications also were assessed.
Management information
Registered date
| 2024 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064444
