NCT06379204CompletedNot Applicable
A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test
Taiyuan Central Hospital of Shanxi Medical University1 site in 1 country52 target enrollmentStarted: November 4, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Peak oxygen uptake
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
the maximum physiological value standardized group
Experimental
Intervention: the maximum physiological value standardized group (Behavioral)
the ventilatory threshold individualized group
Active Comparator
Intervention: the ventilatory threshold individualized group (Behavioral)
Outcomes
Primary Outcomes
Peak oxygen uptake
Time Frame: From enrollment to the end of 12 weeks of treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Liu Ruojiang
Chief Therapist
Taiyuan Central Hospital of Shanxi Medical University
Study Sites (1)
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