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Completed

NCT Number: NCT06379204

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taiyuan Cardiac Rehabilitation Center

Taiyuan, Shanxi, 030009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients were aged 25 to 65 years, with no restrictions on number of males or females.
  • 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.
  • Patients were willing to participate and sign the informed consent form.

Exclusion criteria

  • Patients in an acute phase of various diseases or with organ failure, tumor, myocardial infarction, cardiac insufficiency, myocarditis, or chronic lung disease;
  • Patients with long-term alcohol consumption and those unable to ensure regular lifestyle habits during the intervention period;
  • Patients who were unable to ensure that they would carry out the stipulated exercise protocol during the intervention; and
  • Patients with drug modifications during the intervention that could affect the outcome markers.

Treatment and study plan

the maximum physiological value standardized group

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

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.

Primary outcomes

  1. Peak oxygen uptake

    Time frame: From enrollment to the end of 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Taiyuan Central Hospital of Shanxi Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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