NCT06528639招募中不适用
Primary Prevention Study of Cardiovascular Diseases and Diabetes in the Population With Metabolic Syndrome-A Clinical Study on Physical Exercise Guided by Cardiopulmonary Exercise Testing to Reduce the Risk of Metabolic Cardiovascular Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in composite cardiovascular disease risk score (z-score)
研究概览
简要总结
The main purpose of this study is to validate the effect of an individualized exercise prescription developed based on cardiopulmonary exercise testing (CPET) in subjects with metabolic syndrome. This study aims to assess the improvement in cardiovascular metabolic risk associated with the personalized exercise regimen,known as individualized HIIT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 65, for both males and females;
- •Inadequate exercise: Sedentary lifestyle: Sitting for more than 6 hours daily over the past 6 months; Insufficient physical activity evaluated by the International Physical Activity Questionnaire (IPAQ), with an average weekly duration of moderate-intensity physical activity less than 150 minutes or high-intensity physical activity less than 75 minutes;
- •Meeting the criteria for metabolic syndrome according to the 2009 AHA/IDF definition: Must have three or more of the following: Abdominal obesity(Waist circumference ≥90 cm for males, ≥80 cm for females); Elevated fasting blood glucose: ≥5.6 mmol/L; Elevated blood pressure: Systolic blood pressure ≥130 mm Hg, or diastolic blood pressure ≥85 mm Hg; Elevated fasting triglycerides (TG): ≥1.7 mmol/L (150 mg/dl); Reduced fasting high-density lipoprotein cholesterol (HDL-C): <1.0 mmol/L for males, <1.3 mmol/L for females.
- •Additionally, must meet the following conditions: TG <500 mg/dl (5.6 mmol/L); fasting blood glucose <7 mmol/L; baseline blood pressure <140/90 mm Hg;
- •Willingness to improve health status through reasonable exercise.
排除标准
- •Contraindications to CPET (Cardiopulmonary Exercise Testing);
- •Positive results in CPET exercise electrocardiogram;
- •The patient has elevated LDL-C levels and has been indicated for statin therapy.
- •Currently undergoing treatment with antihypertensive, antidiabetic, lipid-lowering, or antiarrhythmic medications;
- •The doctor evaluates dietary supplements or over-the-counter medications that may affect the results (such as fish oil products, red yeast rice extract, over-the-counter weight loss drugs, meal replacements, probiotics, berberine, etc.)
- •Mental disorders;
- •Conditions related to exercise impairment, or occurrence of lower limb exercise-related injuries in the past 6 months;
- •Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- •Other situations deemed unsuitable for participation in this study by the researchers;
- •Refusal to sign the informed consent form.
结局指标
主要结局
Change in composite cardiovascular disease risk score (z-score)
时间窗: through study completion, an average of 2 year
The primary outcome is the change from baseline in the composite cardiovascular disease risk score (z-score) calculated using resting blood pressure, high-density lipoprotein cholesterol, fasting glucose, waist circumference and triglyceride. Each risk factor will be individually standardized and expressed as sex-specific z-score by using the formula = (value - mean)/standard deviation for each participant.
次要结局
- Biochemical and metabolic indicators(through study completion, an average of 2 year)
- CPET (Cardiopulmonary Exercise Testing) related indicators(through study completion, an average of 2 year)
- calf circumference, waist circumference, and hip circumference(through study completion, an average of 2 year)
- Oral Glucose Tolerance Test (OGTT) Related Indicators(through study completion, an average of 2 year)
研究者
Tang Yida
Professor
Peking University Third Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Autonomic Nervous System and Exercise In Gestational DiabetesGestational DiabetesCardiovascular Risk FactorsNCT01675271Helsinki University Central Hospital66
进行中（未招募）
不适用
Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac EventsCardiovascular Primary Prevention StrategyNCT03439267Intermountain Health Care, Inc.5,765
已完成
不适用
Prestudy: Lifestyle and Cardiovascular DiseaseCardiovascular DiseasesObesityDiabetes MellitusNCT00592397Norwegian University of Science and Technology5
已完成
不适用
NC Enhanced WISEWOMAN ProjectCardiovascular DiseaseNCT00288327University of North Carolina, Chapel Hill258
已完成
不适用
Staying Healthy Through Education and Prevention StudyDisabilityNCT00817193LeadingAge320