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

NCT06379204 | Completed DMC

• 1 other identifier: No.2022026
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake

  From enrollment to the end of 12 weeks of treatment

Study Arms (2)

the maximum physiological value standardized group

EXPERIMENTAL

Behavioral: the maximum physiological value standardized group

the ventilatory threshold individualized group

ACTIVE COMPARATOR

Behavioral: the ventilatory threshold individualized group

Interventions

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 maximum physiological value standardized group

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.

the ventilatory threshold individualized group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taiyuan Central Hospital of Shanxi Medical University: lead

Study Sites (1)

Taiyuan Cardiac Rehabilitation Center

Taiyuan, Shanxi, 030009, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Therapist

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: November 4, 2022
• Primary Completion: August 30, 2023
• Study Completion: September 19, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (1)