Actively Recruiting
Primary Prevention Study of Cardiovascular Diseases and Diabetes in People With Metabolic Syndrome Using Exercise Guided by Cardiopulmonary Exercise Testing
Led by Peking University Third Hospital · Updated on 2024-07-30
220
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
B
Beijing Chao Yang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a personalized exercise plan based on cardiopulmonary exercise testing (CPET) for people with metabolic syndrome. The study aims to see if this individualized high-intensity interval training (HIIT) can reduce cardiovascular and metabolic risks in this population. The trial is designed to validate how well the exercise prescription improves health outcomes related to metabolic cardiovascular diseases. Participants are randomly assigned to one of two groups. One group receives supervised individualized HIIT guided by CPET three times a week for 24 weeks, with exercise prescriptions adjusted after 12 weeks based on testing results. They also receive guidance on healthy dietary habits. The control group receives only guidance on healthy diet and exercise methods and can choose to start HIIT or home training after 24 weeks. Throughout the study, participants undergo various assessments including CPET, inspiratory muscle strength tests, and measurements of biochemical, metabolic, and physical indicators like waist and hip circumference. The main outcome measured is the change in a composite cardiovascular disease risk score over approximately two years. Safety and health improvements are monitored during the study and follow-up periods.
CONDITIONS
Brief Title
A Clinical Study on Exercise Guided by CPET to Reduce the Risk of Metabolic Cardiovascular Diseases（C-MET Trial）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 65 years, male or female
- Sedentary lifestyle with sitting more than 6 hours per day over the past 6 months
- Insufficient physical activity: less than 150 minutes of moderate or 75 minutes of high-intensity activity weekly as per IPAQ
- Diagnosis of metabolic syndrome by having three or more of the following: abdominal obesity (waist circumference ≥90 cm for males, ≥80 cm for females), fasting blood glucose ≥5.6 mmol/L, elevated blood pressure (≥130/85 mm Hg), fasting triglycerides ≥1.7 mmol/L, or low HDL cholesterol (<1.0 mmol/L for males, <1.3 mmol/L for females)
- Additional criteria: triglycerides <500 mg/dl, fasting blood glucose <7 mmol/L, baseline blood pressure <140/90 mm Hg
- Willingness to improve health through exercise
You will not qualify if you...
- Contraindications to cardiopulmonary exercise testing (CPET)
- Abnormal results on CPET exercise electrocardiogram
- Elevated LDL cholesterol requiring statin therapy
- Currently treated with antihypertensive, antidiabetic, lipid-lowering, or antiarrhythmic drugs
- Use of dietary supplements or over-the-counter medications affecting study results (e.g., fish oil, red yeast rice, weight loss drugs, probiotics, berberine)
- Mental disorders
- Exercise impairment or lower limb injury in the past 6 months
- Pregnant, breastfeeding, or planning pregnancy
- Any condition deemed unsuitable by researchers
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants in the exercise group undergo supervised individualized high-intensity interval training (HIIT) guided by cardiopulmonary exercise testing (CPET) three times per week for 24 weeks. Participants also receive guidance on healthy dietary habits. At 12 weeks, CPET and inspiratory muscle strength tests are conducted to evaluate training effects and adjust exercise prescriptions. Participants in the control group receive guidance on healthy dietary habits and exercise methods without supervised training.
Three visits per week for supervised exercise sessions; assessments at baseline, Week 12, and Week 24
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
J
Jun Gao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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