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

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06379204
• Other study ID #: No.2022026
• Status: Completed
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: September 19, 2023

Study information

• Verified date: April 2024
• Source: Taiyuan Central Hospital of Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 19, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
China	Taiyuan Cardiac Rehabilitation Center	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Taiyuan Central Hospital of Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake		From enrollment to the end of 12 weeks of treatment