- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06275009
Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina) (LiFitChina)
Effects of Lifestyle and Physical Fitness on Cardiovascular Health: a Cohort Study in Chinese Occupational Population
The incidence and prevalence of metabolic risk factors such as obesity, hypertension, diabetes, and dyslipidemia, as well as cardiovascular diseases (CVD), are continuously rising among the occupational population in China, primarily comprising the middle-aged and young adults. Unhealthy lifestyles and declining physical fitness are independent risk factors affecting cardiovascular health. Additionally, the level of physical fitness is influenced by postnatal lifestyles. Lifestyle factors related to cardiovascular health in the occupational population encompass various aspects, including smoking, physical activity, diet, sleep, psychological stress, etc. These factors may interact or have a synergistic effect, necessitating a comprehensive assessment.
This project proposes a prospective cohort study design to establish a monitoring cohort for lifestyle and physical fitness among the occupational population. The study will track and follow individuals with or without any CVD metabolic risk factors, collecting information on general status, lifestyle, physical fitness, and health examination data. Exposure factors such as lifestyle and physical fitness will be measured annually, and the occurrence of CVD-related health outcomes will be observed. The aim is to develop a comprehensive evaluation index for cardiovascular health lifestyle, analyze the direct and indirect impacts of lifestyle and physical fitness on the occurrence and development of CVD, and explore potential mediating and moderating effects of physical fitness in the association between lifestyle and cardiovascular health.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hongyi Du, MD PhD
- Phone Number: 86-10-88396087
- Email: duhy@bjmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- Xue Feng, MD PhD
- Phone Number: +86-15601378512
- Email: 29611290@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults between 18-59 years of age
- occupational staff
- willing to accept long-term follow-up
Exclusion Criteria:
- participants with previous CVD history such as myocardial infarction, stroke and severe aortic stenosis;
- with cancer;
- with congenital genetic diseases, or cannot cooperate with the investigation and follow-up due to acquired diseases, such as congenital heart disease, paralysis, deafness, dementia, mental abnormality, developmental retardation, etc.;
- with exercise contraindications;
- duration of pregnancy;
- refuse to sign the informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the composite end point of new major adverse cardiovascular events
Time Frame: 10 years
|
including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina pectoris requiring hospitalization
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
new incidence of each major adverse cardiovascular events
Time Frame: 10 years
|
new incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, unstable angina requiring hospitalization and other major adverse cardiovascular events
|
10 years
|
|
new incidence of cancer
Time Frame: 10 years
|
new incidence of cancer and all-cause death
|
10 years
|
|
new incidence of all-cause death
Time Frame: 10 years
|
new incidence of all-cause death
|
10 years
|
|
level of systolic pressure
Time Frame: 10 years
|
The level of systolic pressure measured at each follow-up evaluation time point
|
10 years
|
|
level of diastolic pressure
Time Frame: 10 years
|
The level of diastolic pressure measured at each follow-up evaluation time point
|
10 years
|
|
level of blood lipid
Time Frame: 10 years
|
The level of blood lipid measured at each follow-up evaluation time point
|
10 years
|
|
level of BMI
Time Frame: 10 years
|
The level of BMI (weight and height will be combined to report BMI in kg/m^2) measured at each follow-up evaluation time point
|
10 years
|
|
level of maximal oxygen uptake (VO2max)
Time Frame: 10 years
|
The level of VO2max which is obtained by submaximal exercise testing on cycle ergometer with two-stage workload to assess cardiorespiratory fitness measured at each follow-up evaluation time point
|
10 years
|
|
level of metabolic equivalents (METs)
Time Frame: 10 years
|
The level of METs which is obtained by submaximal exercise testing on cycle ergometer with two-stage workload to assess cardiorespiratory fitness measured at each follow-up evaluation time point
|
10 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-1990
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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