A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test

NCT ID: NCT06379204

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2023-09-19

Brief Summary

Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

the maximum physiological value standardized group

Group Type: EXPERIMENTAL

the maximum physiological value standardized group

Intervention Type: BEHAVIORAL

10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and HRR heart rate reserve method, gradually increasing.

the ventilatory threshold individualized group

Group Type: ACTIVE_COMPARATOR

the ventilatory threshold individualized group

Intervention Type: BEHAVIORAL

10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and three zone threshold model, gradually increasing.

Interventions

the maximum physiological value standardized group

10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and HRR heart rate reserve method, gradually increasing.

Intervention Type: BEHAVIORAL

the ventilatory threshold individualized group

10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and three zone threshold model, gradually increasing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients were included who met the Chinese Diabetic Society diagnostic criteria for MS-i.e., three or more of the following five items: (i) abdominal obesity (i.e., central obesity) with waist circumference ≥ 90 cm in males and ≥ 85 cm in females; (ii) hyperglycemia defined as fasting blood glucose ≥ 6.1 mmol/L or blood glucose ≥ 7.8 mmol/L two hours after glucose loading, or diagnosis of diabetes mellitus; (iii) hypertension defined as blood pressure ≥ 130/85 mmHg or diagnosed with hypertension; (iv) fasting triglycerides (TG) ≥ 1.70 mmol/L; and (v) fasting high-density lipoprotein cholesterol (HDL-C) < 1.04 mmol/L.

2. Patients were aged 25 to 65 years, with no restrictions on number of males or females.

3. Patients exhibited a long-term sedentary lifestyle and did not carry out moderate-intensity physical activity for at least three d/week of 30 min/d duration within three months of the study.

4. Patients were willing to participate and sign the informed consent form.

Exclusion Criteria

1. Patients in an acute phase of various diseases or with organ failure, tumor, myocardial infarction, cardiac insufficiency, myocarditis, or chronic lung disease;

2. Patients with long-term alcohol consumption and those unable to ensure regular lifestyle habits during the intervention period;

3. Patients who were unable to ensure that they would carry out the stipulated exercise protocol during the intervention; and

4. Patients with drug modifications during the intervention that could affect the outcome markers.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiyuan Central Hospital of Shanxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Liu Ruojiang

Chief Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taiyuan Cardiac Rehabilitation Center

Taiyuan, Shanxi, China

Countries

China

Other Identifiers

No.2022026

Identifier Type: -

Identifier Source: org_study_id