Exercise program to lower metabolic cardiovascular disease risk

Primary Prevention Study of Cardiovascular Diseases and Diabetes in the Population With Metabolic Syndrome-A Clinical Study on Physical Exercise Guided by Cardiopulmonary Exercise Testing to Reduce the Risk of Metabolic Cardiovascular Diseases

This study is testing whether a personalized exercise program can help people with metabolic syndrome lower their risk of heart and metabolic problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06528639 on ClinicalTrials.gov

What this trial studies

This study aims to validate the effectiveness of a personalized exercise regimen based on cardiopulmonary exercise testing (CPET) for individuals with metabolic syndrome. Participants will engage in individualized high-intensity interval training (HIIT) designed to improve their cardiovascular and metabolic health. The study will assess the impact of this tailored exercise approach on reducing cardiovascular metabolic risks associated with a sedentary lifestyle. By focusing on those who meet specific criteria for metabolic syndrome, the study seeks to provide targeted interventions for this high-risk population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 65 who lead a sedentary lifestyle and meet the criteria for metabolic syndrome.

Not a fit: Patients who are already physically active or do not meet the metabolic syndrome criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of metabolic cardiovascular diseases in individuals with metabolic syndrome.

How similar studies have performed: Other studies have shown positive outcomes with personalized exercise interventions for metabolic syndrome, suggesting this approach has potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yi-Da Tang, MD, PhD — Peking University Third Hospital
• Study coordinator: Jun Gao, PhD

Conditions Metabolic Syndrome; metabolic syndrome; insufficient exercise