Exercise Intensity and Muscle Recovery in Statin Users
Investigating the Role of Mechanical Muscle Loading in the Context of Preventive Exercise for Statin Users - a Pilot Study
Raffaele Mazzolari
40 participants
Apr 20, 2026
INTERVENTIONAL
Conditions
Summary
This study aims to investigate how different types and intensities of exercise affect muscle recovery in individuals taking statin medications compared to healthy controls. Statins are essential for cardiovascular prevention but are often associated with muscle-related side effects (SAMS), which can be exacerbated by physical activity. The study will compare aerobic cycling (low muscular strain) with resistance training (RT) at increasing intensities (40%, 60%, and 80% of estimated 1-repetition maximum; e1RM). Researchers will measure markers of muscle damage, such as creatine kinase (CK) levels, and subjective recovery needs to determine which exercise modalities and intensities are best tolerated by statin users. The goal is to provide evidence for more individualized and safer exercise recommendations for this population.
Eligibility
Inclusion Criteria7
- Sedentary behavior (defined as < 1 hour of planned physical activity per week)
- Low occupational physical activity
- Age between 30 and 65 years
- Non-smoker
- Medical clearance to partake in physical exercise (as determined during screening visit)
- For statin users: Current statin medication with stable dosage for at least 8 weeks prior to enrollment
- For controls: Statin-naïve individuals
Exclusion Criteria5
- BMI < 20 kg/m² or > 30 kg/m²
- Smoking or smoking cessation < 1 year ago
- Medical conditions or musculoskeletal issues that preclude eligibility for full physical effort or interfere with outcome measures
- Medication (other than statins) that may interfere with physical exercise or outcome measures (assessment on a case-by-case basis during screening visit)
- Any condition identified during screening (e.g., abnormal ECG, cardiopulmonary exercise test) that, in the opinion of the physician, precludes safe participation
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
A dose-escalation protocol consisting of END (40 minutes of cycling at 60% HRR) and RT at 40%, 60%, and 80% of e1RM. RT includes 8 machine-based exercises, 2 sets per exercise, with repetitions decreasing as intensity increases (20, 12, and 8 reps respectively). Each intensity period comprises two identical sessions with a 5-21 day washout. All sessions are supervised.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07563452