UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053691 |
|---|---|
| Receipt number | R000061272 |
| Scientific Title | Aerobic exercise habits may be associated with lower systemic cellular immune inflammation and higher albumin-to-globulin ratio: implication of preventive effect of aerobic exercise on atherosclerotic cardiovascular disease |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/02/23 15:06:17 |
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Basic information
Public title
Aerobic exercise habits may be associated with lower systemic cellular immune inflammation and higher albumin-to-globulin ratio: implication of preventive effect of aerobic exercise on atherosclerotic cardiovascular disease
Acronym
Aerobic exercise habits may be associated with lower systemic cellular immune inflammation and higher albumin-to-globulin ratio: implication of preventive effect of aerobic exercise on atherosclerotic cardiovascular disease
Scientific Title
Aerobic exercise habits may be associated with lower systemic cellular immune inflammation and higher albumin-to-globulin ratio: implication of preventive effect of aerobic exercise on atherosclerotic cardiovascular disease
Scientific Title:Acronym
Association of inflammation and A/G ratio with aerobic exercise habits
Region
| Japan |
Condition
Condition
Atherosclerotic cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the association between aerobic exercise habits, AGR, and cellular immune-inflammation markers in annually health-checked participants with no ASCVD history and examined the role of cellular immune inflammation markers as a mediator in the association between aerobic exercise habits and AGR using causal median analysis.
Basic objectives2
Others
Basic objectives -Others
This study aimed to investigate the association between aerobic exercise habits, AGR, and cellular immune-inflammation markers in annually health-checked participants with no ASCVD history and examined the role of cellular immune inflammation markers as a mediator in the association between aerobic exercise habits and AGR using causal median analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to investigate the association between aerobic exercise habits, AGR, and cellular immune-inflammation markers in annually health-checked participants with no ASCVD history
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
participants receving annual health check
Key exclusion criteria
refusal to provide informed consent: ASCVD history; white blood cell count more than 10,000, C-reactive protein level more than 2.0 mg/dL, positive for hepatitis B virus surface antigen, hepatitis C antibodies, liver cirrhosis, hepatocellular carcinoma, or metastatic liver cancer, or nephrosis, multiple myeloma, hyperthyroidism or absent data for WBC count, CRP levels, and AGR.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center of Nihon University Hospital
Zip code
101-0062
Address
1-6 Kandasurugadai, chiyodaku, Tokyo, Japan
TEL
09080537841
tani.shigemasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital Health Planning Center
Division name
Nihon University Hospital Health Planning Center
Zip code
101-0062
Address
1-6 Kandasurugadai, chiyodaku
TEL
09080537841
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Shigemasa Tani
Funding Source
Organization
Nihon University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital IRB
Address
Kandasurugadai1-6, Chiyodaku, Tokyo
Tel
09080537841
tani.shigemasa@nihon-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
| 2024 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2024 | Year | 02 | Month | 23 | Day |
Last modified on
| 2025 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061272
