Effects of a 12-Week Waltz Dance Intervention on Cardiovascular Health in Women Aged 45-65 With Dyslipidemia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Total Cholesterol (TC) Level
研究概览
简要总结
The goal of this clinical trial is to learn whether Waltz dance can improve cardiometabolic and bone health in sedentary women aged 45-65 with abnormal lipid levels. The main questions it aims to answer are:
Can Waltz dance improve blood lipid profiles, including total cholesterol, triglycerides, HDL-C, and LDL-C? Can it improve body composition, cardiorespiratory fitness, vascular function, and bone mineral density? Researchers will compare a Waltz dance group with a control group that maintains their usual lifestyle to see if the dance intervention leads to better health outcomes.
Participants will:
Attend supervised Waltz dance classes three times a week for 12 weeks, each session lasting 105 minutes.
Complete physical tests and blood draws before and after the program to measure changes in lipid levels, body composition, fitness, and bone density.
Wear an accelerometer to monitor energy expenditure and physical activity during the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged between 45 and 65 years.
- •Diagnosed with dyslipidemia (based on clinical lipid profile: TC ≥ 6.2 mmol/L, TG ≥ 2.3 mmol/L, LDL-C ≥ 4.1 mmol/L, or HDL-C < 1.0 mmol/L).
- •Sedentary lifestyle (less than 60 minutes of structured physical activity per week in the last 6 months).
- •Able to participate safely in moderate-intensity exercise as confirmed by a medical evaluation.
- •Willing to participate in a 12-week supervised exercise program, 3 times per week.
- •Able to understand study procedures and provide written informed consent.
排除标准
- •Diagnosis of cardiovascular disease requiring medical supervision during exercise (e.g., unstable angina, recent myocardial infarction).
- •Severe musculoskeletal disorders (e.g., advanced osteoarthritis, recent fractures) limiting mobility or physical activity.
- •Neurological or cognitive disorders affecting motor function or communication.
- •Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg at rest).
- •Diagnosed osteoporosis with high fracture risk (T-score ≤ -2.5 and history of fragility fractures).
- •Any endocrine disorder that significantly affects lipid metabolism (e.g., uncontrolled thyroid disease, Cushing's syndrome).
- •Participation in structured exercise or dance programs within the past 12 months.
- •Current use of medications significantly affecting lipid levels (e.g., high-dose statins) unless dose has been stable for at least 3 months.
- •Any condition judged by the investigator to interfere with safe participation in the study.
结局指标
主要结局
Total Cholesterol (TC) Level
时间窗: From enrollment to the end of treatment at 12 weeks
Total cholesterol (TC) levels will be measured using fasting venous blood samples collected at baseline and after 12 weeks of intervention. Blood will be drawn in the morning after at least 8 hours of fasting. Serum will be analyzed in a certified laboratory using standard enzymatic colorimetric assays. TC is expressed in milligrams per deciliter (mg/dL). Elevated TC is a known risk factor for cardiovascular disease. Changes from baseline to post-intervention will be calculated.
Triglycerides (TG) Level
时间窗: From enrollment to the end of treatment at 12 weeks
Triglyceride (TG) levels will be assessed through fasting blood samples taken before and after the 12-week intervention. Samples will be processed using standardized laboratory techniques. TG is measured in mg/dL and high levels are associated with increased risk for metabolic and cardiovascular conditions. This outcome measures the change in TG levels between baseline and the end of the study.
High-Density Lipoprotein Cholesterol (HDL-C) Level
时间窗: From enrollment to the end of treatment at 12 weeks
HDL-C will be measured in serum obtained from fasting venous blood samples collected at baseline and 12 weeks. HDL-C is commonly known as "good" cholesterol due to its protective effect against cardiovascular disease. Standard enzymatic methods will be used for quantification. The change in HDL-C from baseline to post-intervention will be analyzed.
Low-Density Lipoprotein Cholesterol (LDL-C) Level
时间窗: From enrollment to the end of treatment at 12 weeks
LDL-C will be measured from fasting blood samples collected at the beginning and end of the 12-week intervention. LDL-C, often referred to as "bad" cholesterol, is a key risk factor for atherosclerosis and cardiovascular disease. The value will be determined using direct measurement or calculation by the Friedewald formula. Results will be reported in mg/dL, and changes from baseline to week 12 will be evaluated.
次要结局
- Systolic and Diastolic Blood Pressure and Pulse Pressure (mmHg)(From enrollment to the end of treatment at 12 weeks)
- Pulse Wave Velocity (m/s)(From enrollment to the end of treatment at 12 weeks)
- Ankle-Brachial Index (ABI)(From enrollment to the end of treatment at 12 weeks)
- Cardiorespiratory Fitness - Maximal Oxygen Uptake (VO2max)(From enrollment to the end of treatment at 12 weeks)
- Peak Exercise Heart Rate (bpm)(From enrollment to the end of treatment at 12 weeks)