Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina)

Cardiovascular Diseases Clinical Trial

— LiFitChina  

Official title:

Effects of Lifestyle and Physical Fitness on Cardiovascular Health: a Cohort Study in Chinese Occupational Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275009
• Other study ID #: 2023-1990
• Status: Recruiting
• Start date: December 11, 2023
• Est. completion date: December 11, 2026

Study information

• Verified date: February 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Hongyi Du, MD PhD
• Phone: 86-10-88396087
• Email: duhy[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18512
• Est. completion date: December 11, 2026
• Est. primary completion date: December 11, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lifestyle
• Physical Fitness

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the composite end point of new major adverse cardiovascular events	including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina pectoris requiring hospitalization	10 years
Secondary	new incidence of each major adverse cardiovascular events	new incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, unstable angina requiring hospitalization and other major adverse cardiovascular events	10 years
Secondary	new incidence of cancer	new incidence of cancer and all-cause death	10 years
Secondary	new incidence of all-cause death	new incidence of all-cause death	10 years
Secondary	level of systolic pressure	The level of systolic pressure measured at each follow-up evaluation time point	10 years
Secondary	level of diastolic pressure	The level of diastolic pressure measured at each follow-up evaluation time point	10 years
Secondary	level of blood lipid	The level of blood lipid measured at each follow-up evaluation time point	10 years
Secondary	level of BMI	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
Secondary	level of maximal oxygen uptake (VO2max)	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
Secondary	level of metabolic equivalents (METs)	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