Side effects of statins: from pathophysiology and epidemiology to diagnostic and therapeutic implications.
Massimiliano Ruscica, Nicola Ferri, Maciej Banach...
https://pubmed.ncbi.nlm.nih.gov/35238338Actively Recruiting
Led by Raffaele Mazzolari · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
R
Raffaele Mazzolari
Lead Sponsor
U
Universitaet Innsbruck
Collaborating Sponsor
Researchers are evaluating how different types and intensities of exercise affect muscle recovery in people taking statin medications compared to healthy individuals not using statins. The study aims to understand muscle-related side effects linked to statins, especially when combined with physical activity, to help create safer exercise guidelines for statin users. This is a non-randomized, dose-escalation trial comparing statin users with matched controls based on age, sex, and body mass index. Participants will undergo a stepwise exercise program starting with aerobic cycling for 40 minutes at 60% heart rate reserve, followed by resistance training at increasing intensities of 40%, 60%, and 80% of an estimated one-repetition maximum. Resistance training includes eight machine-based exercises with repetitions decreasing as intensity rises. Each intensity phase consists of two sessions separated by a 5 to 21-day rest period, with all sessions supervised for safety and proper technique. During the study, participants will have medical screening and baseline tests including blood samples and pain assessments. Before and after each exercise session, muscle damage markers, pain thresholds, heart rate, blood lactate, and perceived exertion will be recorded. Participants will also complete daily questionnaires on muscle symptoms and recovery needs. The main measure is the change in blood creatine kinase levels 24 hours after exercise, with study duration per participant under four months.
CONDITIONS
Exercise Intensity and Muscle Recovery in Statin Users
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical history, physical exam, ECG, and exercise test
Duration - 1 week
Participants undergo baseline measurements including capillary blood sampling for CK and assessment of pressure pain threshold on the rectus femoris.
2 visits for baseline measurements
Duration - Approximately 1 week
Participants attend two low-intensity resistance training sessions to learn correct technique and breathing.
2 in-person sessions
Duration - 1 week
Participants perform testing to determine maximal load for 10 controlled repetitions for resistance training intensity prescription.
Up to 1 visit with multiple attempts
Duration - Up to 3 months
Participants complete a dose-escalation exercise protocol starting with endurance cycling sessions followed by resistance training at increasing intensities (40%, 60%, 80% of estimated 1RM). Each intensity period includes two supervised sessions separated by a 5 to 21 day washout.
Multiple supervised sessions: 2 endurance sessions plus 6 resistance training sessions (2 sessions per intensity level)
Duration - Throughout the exercise intervention duration
Participants complete daily online questionnaires to monitor muscle symptoms and recovery needs throughout the intervention period.
Daily online submissions
Total: 1 location
1
University of Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
R
Raffaele Mazzolari, Dr.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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