How exercise intensity affects muscle recovery in people taking statins
Investigating the Role of Mechanical Muscle Loading in the Context of Preventive Exercise for Statin Users - a Pilot Study
This study tests which exercise types and intensities (cycling vs resistance at 40%, 60%, and 80% of e1RM) are best tolerated by adults taking statins compared with similar adults not on statins.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT07563452 on ClinicalTrials.gov |
What this trial studies
This is a matched-pairs, non-randomized, dose-escalation exercise protocol comparing statin users with statin‑naïve controls matched by sex, age, and BMI. All participants begin with an endurance cycling session and then progress through resistance training at 40%, 60%, and 80% of estimated 1‑repetition maximum, with within-subject replication and washout periods. Researchers measure biochemical markers of muscle damage (creatine kinase), pressure pain threshold, and subjective recovery to quantify muscle stress and recovery after each session. The goal is to identify which exercise modalities and intensities are best tolerated by statin users to inform individualized recommendations.
Who should consider this trial
Good fit: Sedentary adults aged 30–65 with BMI 20–30 kg/m² who are non-smokers and medically cleared, either on a stable statin dose for at least 8 weeks or statin‑naïve controls matched to statin users, are ideal candidates.
Not a fit: People outside the age or BMI limits, current or recent smokers, those with musculoskeletal or cardiopulmonary conditions that prevent full effort, or those on unstable or interacting medications are unlikely to qualify or gain benefit.
Why it matters
Potential benefit: If successful, the results could help clinicians provide safer, individualized exercise advice that reduces muscle damage and discomfort for people taking statins.
How similar studies have performed: Previous studies show mixed results—exercise is often safe and beneficial for many statin users, but direct controlled comparisons of exercise modality and stepwise intensity like this are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Innsbruck, Tyrol
- University of Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
Study contacts
- Study coordinator: Raffaele Mazzolari, Dr.
- Email: raffaele.mazzolari@i-med.ac.at
- Phone: +393468754234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.