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

NCT ID: NCT06528639

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Individualized HIIT Group

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

Group Type: EXPERIMENTAL

HIIT

Intervention Type: BEHAVIORAL

Three times a week, 10 sets each session, for 24 weeks of high-intensity interval training.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HIIT

Three times a week, 10 sets each session, for 24 weeks of high-intensity interval training.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role: collaborator

Qingdao Municipal Hospital

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tang Yida

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi-Da Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Gao, PhD

Role: CONTACT

puthxnk@126.com

+86-10-82266697

Facility Contacts

Wenyao Wang, MD, PhD

Role: primary

18810488381

Other Identifiers

M2024315

Identifier Type: -

Identifier Source: org_study_id