The Effects of Rosuvastatin on Running Training Adaptation and Safety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University WanFang Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years.
Family history of hyperlipidemia.
LDL-C ≥ 160 mg/dL.
10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk ≥ 7.5%
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Rosuvastatin
DrugRosuvastatin 10 mg tablet taken orally once daily at bedtime for 3 months.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Rosuvastatin groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
VO₂max (mL/kg/min)
Maximum oxygen consumption obtained from cardiopulmonary exercise testing (CPET). Used to assess changes in cardiopulmonary fitness over the 3-month intervention period.
Time frame
Baseline (Month 0), Month 1, Month 2, Month 32
Aerobic Threshold (AT)
Aerobic threshold determined by standardized CPET. Represents the transition from aerobic to anaerobic metabolism during exercise.
Time frame
Baseline, Month 1, Month 2, Month 33
Respiratory Compensation Point (RCP)
RCP measured via CPET, representing the ventilatory response to metabolic acidosis. Used to evaluate endurance training adaptation.
Time frame
Baseline, Month 1, Month 2, Month 3Secondary outcomes
1
Calculated Training Load Score (using TRIMP method)
Training load is reported as a single Training Impulse (TRIMP) score. It is calculated by multiplying exercise duration (minutes) by a heart-rate-based intensity factor (e.g., fractional heart rate reserve). This integrates two metrics into one unified numerical value. The formula is: TRIMP = Duration (min) x \[ΔHR ratio\] x y Where: ΔHR ratio = (HR\_ex - HR\_rest) / (HR\_max - HR\_rest) y = A weighting factor derived from an exponential function to account for the disproportionate increase in physiological strain at higher exercise intensities (using gender-specific constants: 0.64e\^(1.92x) for males and 0.86e\^(1.67x) for females).
Time frame
Through the end of the 3-month intervention period2
Number of Participants with Statin-Associated Muscle Symptoms (SAMS)
Number of participants reporting any muscle soreness, weakness, or stiffness as assessed by the SAMS questionnaire.
Time frame
Month 1, Month 2, and Month 33
Change from Baseline in Body Weight (kg)
Body weight measured in kilograms (kg) to evaluate changes during the training and intervention period.
Time frame
Baseline, Month 1, Month 2, Month 34
Change from Baseline in Body Mass Index (kg/m^2)
Body Mass Index (BMI) calculated as weight in kilograms divided by height in meters squared (kg/m\^2).
Time frame
Baseline, Month 1, Month 2, Month 3Sponsors and contacts
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Source ClinicalTrials.gov
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