Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
Healthy Volunteers
ID07563452

Investigating the Role of Mechanical Muscle Loading in Preventive Exercise for Statin Users - a Pilot Study

Led by Raffaele Mazzolari · Updated on 2026-05-04

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Raffaele Mazzolari

Lead Sponsor

U

Universitaet Innsbruck

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Exercise Intensity and Muscle Recovery in Statin Users

Who Can Participate

Age: 30Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Sedentary behavior defined as less than 1 hour of planned physical activity per week
  • Low occupational physical activity
  • Age between 30 and 65 years
  • Non-smoker
  • Medical clearance to participate in physical exercise
  • For statin users: stable statin medication dosage for at least 8 weeks
  • For controls: statin-nave individuals
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) less than 20 kg/m or greater than 30 kg/m
  • Current smoking or smoking cessation less than 1 year ago
  • Medical or musculoskeletal conditions preventing full physical effort or interfering with study measures
  • Use of medications other than statins that may affect exercise or outcomes (evaluated case-by-case)
  • Any condition identified during screening (e.g., abnormal ECG or exercise test) that precludes safe participation

AI-Screening

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Your Study Journey

Screening

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

Baseline Assessments

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

Familiarization

Duration - Approximately 1 week

Participants attend two low-intensity resistance training sessions to learn correct technique and breathing.

2 in-person sessions

10-Repetition Maximum Testing

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

Exercise Intervention

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)

Daily Monitoring During Intervention

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

Trial Site Locations

Total: 1 location

1

University of Innsbruck

Innsbruck, Tyrol, Austria, 6020

Actively Recruiting

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Research Team

R

Raffaele Mazzolari, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Effects of acute exercise and training status on glucocorticoid-induced leucine zipper (GILZ) expression in human skeletal muscle.

A Hecksteden, J Hoppstädter, D A Bizjak...

https://pubmed.ncbi.nlm.nih.gov/37951824

Resistance but not endurance training suppresses glucocorticoid-induced leucine zipper (GILZ) expression in human skeletal muscle.

Sebastian Paul, Lars Donath, Jessica Hoppstädter...

https://pubmed.ncbi.nlm.nih.gov/39499305

Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management.

Erik S Stroes, Paul D Thompson, Alberto Corsini...

https://pubmed.ncbi.nlm.nih.gov/25694464