The Effects of Rosuvastatin on Running Training Adaptation and Safety

February 5, 2026 updated by: Taipei Medical University WanFang Hospital

The Effects of Rosuvastatin on Physiological Adaptation and Safety During Regular Long-Distance Running Training: A Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yu-Hsuan Cheng, MD, MS
  • Phone Number: 886-2-2930-7930 Ext. 1600
  • Email: heathcyh@gmail.com

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Rosuvastatin group
Drug: Rosuvastatin
Rosuvastatin 10 mg tablet taken orally once daily at bedtime for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO₂max (mL/kg/min)
Time Frame: 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.
Baseline (Month 0), Month 1, Month 2, Month 3
Aerobic Threshold (AT)
Time Frame: Baseline, Month 1, Month 2, Month 3
Aerobic threshold determined by standardized CPET. Represents the transition from aerobic to anaerobic metabolism during exercise.
Baseline, Month 1, Month 2, Month 3
Respiratory Compensation Point (RCP)
Time Frame: Baseline, Month 1, Month 2, Month 3
RCP measured via CPET, representing the ventilatory response to metabolic acidosis. Used to evaluate endurance training adaptation.
Baseline, Month 1, Month 2, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculated Training Load Score (using TRIMP method)
Time Frame: Through the end of the 3-month intervention period

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).
Through the end of the 3-month intervention period
Number of Participants with Statin-Associated Muscle Symptoms (SAMS)
Time Frame: Month 1, Month 2, and Month 3
Number of participants reporting any muscle soreness, weakness, or stiffness as assessed by the SAMS questionnaire.
Month 1, Month 2, and Month 3
Change from Baseline in Body Weight (kg)
Time Frame: Baseline, Month 1, Month 2, Month 3
Body weight measured in kilograms (kg) to evaluate changes during the training and intervention period.
Baseline, Month 1, Month 2, Month 3
Change from Baseline in Body Mass Index (kg/m^2)
Time Frame: Baseline, Month 1, Month 2, Month 3
Body Mass Index (BMI) calculated as weight in kilograms divided by height in meters squared (kg/m^2).
Baseline, Month 1, Month 2, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Study Chair: Yu-Hsuan Cheng, MD, MS, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2025102501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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