A Clinical Study on Exercise Guided by CPET to Reduce the Risk of Metabolic Cardiovascular Diseases（C-MET Trial）

Peking University

Status: Enrolling

Conditions: Metabolic Syndrome

Treatments: Behavioral: HIIT

Study type: Interventional

Funder types: Other

Identifiers

NCT06528639

M2024315

Details and patient eligibility

About

The main purpose of this study is to validate the effect of an individualized exercise prescription developed based on cardiopulmonary exercise testing (CPET) in subjects with metabolic syndrome. This study aims to assess the improvement in cardiovascular metabolic risk associated with the personalized exercise regimen,known as individualized HIIT.

Enrollment: 220 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 30 and 65, for both males and females;

2. Inadequate exercise: Sedentary lifestyle: Sitting for more than 6 hours daily over the past 6 months; Insufficient physical activity evaluated by the International Physical Activity Questionnaire (IPAQ), with an average weekly duration of moderate-intensity physical activity less than 150 minutes or high-intensity physical activity less than 75 minutes;

3. Meeting the criteria for metabolic syndrome according to the 2009 AHA/IDF definition: Must have three or more of the following: Abdominal obesity(Waist circumference ≥90 cm for males, ≥80 cm for females); Elevated fasting blood glucose: ≥5.6 mmol/L; Elevated blood pressure: Systolic blood pressure ≥130 mm Hg, or diastolic blood pressure ≥85 mm Hg; Elevated fasting triglycerides (TG): ≥1.7 mmol/L (150 mg/dl); Reduced fasting high-density lipoprotein cholesterol (HDL-C): <1.0 mmol/L for males, <1.3 mmol/L for females.

   Additionally, must meet the following conditions: TG <500 mg/dl (5.6 mmol/L); fasting blood glucose <7 mmol/L; baseline blood pressure <140/90 mm Hg;

4. Willingness to improve health status through reasonable exercise.

Exclusion criteria

1. Contraindications to CPET (Cardiopulmonary Exercise Testing);
2. Positive results in CPET exercise electrocardiogram;
3. The patient has elevated LDL-C levels and has been indicated for statin therapy.
4. Currently undergoing treatment with antihypertensive, antidiabetic, lipid-lowering, or antiarrhythmic medications;
5. The doctor evaluates dietary supplements or over-the-counter medications that may affect the results (such as fish oil products, red yeast rice extract, over-the-counter weight loss drugs, meal replacements, probiotics, berberine, etc.)
6. Mental disorders;
7. Conditions related to exercise impairment, or occurrence of lower limb exercise-related injuries in the past 6 months;
8. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
9. Other situations deemed unsuitable for participation in this study by the researchers;
10. Refusal to sign the informed consent form.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Individualized HIIT Group

Experimental group

Description:

Participants in this group will receive a type of exercise prescription of High-Intensity Interval Training (HIIT). They will undergo supervised individualized intermittent high-intensity training (HIIT) guided by CPET three times per week under the supervision of the hospital. Participants will also receive guidance on healthy dietary habits. At the end of the 12th week, CPET and inspiratory muscle strength tests will be conducted to evaluate the training effects and adjust the exercise prescription. The total duration of the training will be 24 weeks

Treatment:

Behavioral: HIIT

Control Group

No Intervention group

Description:

Participants in this group will receive guidance on healthy dietary habits and exercise methods. They will be informed that after 24 weeks of selection, they will have the option to choose HIIT exercise program or home training.