The Effects of Rosuvastatin on Physiological Adaptation and Safety During Regular Long-Distance Running Training: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VO₂max (mL/kg/min)
研究概览
简要总结
Statins lower low-density lipoprotein cholesterol (LDL-C) and help prevent atherosclerotic cardiovascular disease, but some users develop statin-associated muscle symptoms (SAMS) such as soreness, stiffness, weakness, or elevated creatine kinase (CK). These symptoms may be more noticeable during exercise. Regular long-distance running improves cardiopulmonary fitness-VO₂max, aerobic threshold (AT), and respiratory compensation point (RCP)-mainly through mitochondrial and metabolic adaptations. Prior studies suggest that lipophilic statins like simvastatin may blunt these adaptations, while hydrophilic statins such as rosuvastatin may have a smaller impact. However, prospective data in habitual endurance runners are limited.
This randomized controlled trial will examine how rosuvastatin affects cardiopulmonary fitness improvements and muscle tolerance in individuals who run at least three times per week and meet clinical criteria for statin therapy. After informed consent and baseline cardiopulmonary exercise testing (CPET), participants will be randomized to rosuvastatin 10 mg daily or no statin therapy for three months. Both groups will maintain their usual training routines, and training load will be recorded using heart-rate-based TRIMP. CPET will be repeated monthly to assess changes in VO₂max, AT, and RCP, and muscle enzymes and SAMS will be evaluated at each visit.
The study aims to clarify whether rosuvastatin influences endurance-related physiological adaptations or increases muscle symptoms in regular long-distance runners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years.
- •Meets clinical criteria for statin therapy, including at least one of the following:
- •Family history of hyperlipidemia.
- •LDL-C ≥ 160 mg/dL.
- •10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk ≥ 7.5%
- •Diabetes mellitus with LDL-C ≥ 70 mg/dL.
- •Determined by a clinician to require lipid-lowering therapy.
- •Currently using or eligible to initiate rosuvastatin therapy.
- •Performs long-distance running at least 3 times per week and is willing to maintain regular training for 3 months.
- •Able and willing to undergo cardiopulmonary exercise testing (CPET) and to record training data using a sports watch (for TRIMP calculation).
- •No known drug allergies and provides written informed consent after study explanation.
排除标准
- •Known allergy or intolerance to statins or rosuvastatin.
- •History of severe statin-related adverse events, including rhabdomyolysis or marked creatine kinase (CK) elevation.
- •Liver dysfunction with AST or ALT > 3× upper limit of normal.
- •Moderate to severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- •Current lower-limb pain, tendon injury, or other conditions that prevent running training.
- •Not suitable for maximal cardiopulmonary exercise testing (CPET), such as unstable angina, uncontrolled hypertension, or recent cardiovascular events.
- •Pregnant or breastfeeding.
- •Inability to comply with study procedures, including use of a sports watch, regular follow-up visits, or maintaining running training.
研究组 & 干预措施
Rosuvastatin group
干预措施: Rosuvastatin (Drug)
Control group
结局指标
主要结局
VO₂max (mL/kg/min)
时间窗: Baseline (Month 0), Month 1, Month 2, Month 3
Maximum oxygen consumption obtained from cardiopulmonary exercise testing (CPET). Used to assess changes in cardiopulmonary fitness over the 3-month intervention period.
Aerobic Threshold (AT)
时间窗: Baseline, Month 1, Month 2, Month 3
Aerobic threshold determined by standardized CPET. Represents the transition from aerobic to anaerobic metabolism during exercise.
Respiratory Compensation Point (RCP)
时间窗: Baseline, Month 1, Month 2, Month 3
RCP measured via CPET, representing the ventilatory response to metabolic acidosis. Used to evaluate endurance training adaptation.
次要结局
- Calculated Training Load Score (using TRIMP method)(Through the end of the 3-month intervention period)
- Number of Participants with Statin-Associated Muscle Symptoms (SAMS)(Month 1, Month 2, and Month 3)
- Change from Baseline in Body Weight (kg)(Baseline, Month 1, Month 2, Month 3)
- Change from Baseline in Body Mass Index (kg/m^2)(Baseline, Month 1, Month 2, Month 3)