Statin Adverse ReactionSTN-EXNCT07563452
Exercise Intensity and Muscle Recovery in Statin Users
A study testing Dose-Escalation Exercise Protocol in people with Statin Adverse Reaction, run by Raffaele Mazzolari at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Statin Adverse Reaction
- What is being tested?
- Dose-Escalation Exercise Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University of Innsbruck
Innsbruck, Tyrol, 6020
Raffaele Mazzolari, Dr., +393468754234, raffaele.mazzolari@i-med.ac.at
About this study
Official title: Investigating the Role of Mechanical Muscle Loading in the Context of Preventive Exercise for Statin Users - a Pilot Study
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.
Read the detailed description
Study Design This is a matched-pairs, non-randomized, dose-escalation exercise trial with within-subject replication. Statin users (STN) and statin-naïve controls (CON) are matched by sex, age (±2 years), and body mass index (BMI) (±2 kg/m²). Due to ethical and safety reasons (risk of injury in untrained individuals exposed to high-intensity resistance exercise), the order of experimental periods is fixed: all participants begin with endurance exercise (lowest muscle strain), then progress to resistance training at 40%, 60%, and 80% of e1RM.
Interventions Endurance training sessions (END): 40 minutes cycling at 60% heart rate reserve (HRR), plus 5 min warm-up and cool-down.
Resistance training sessions (RT1-RT3): 8 machine-based exercises (e.g., leg press, chest press, lat pull-down). Two sets per exercise, repetitions decrease with intensity (20 reps at 40% e1RM, 12 reps at 60%, 8 reps at 80%). Rest between sets ~120 sec. Each intensity period includes two identical sessions, separated by a 5-21-day washout.
Procedures Screening: Medical history, physical exam, resting electrocardiogram (ECG), cardiopulmonary exercise test (CPET).
Baseline: Two measurements of CK from capillary blood and pressure pain threshold (PPT) on the rectus femoris.
Familiarization: Two low-intensity RT sessions to teach correct technique and breathing.
10-repetition maximum (10RM) testing: For each RT exercise, participants perform up to three attempts to find the maximal load for 10 controlled repetitions; then e1RM is calculated for intensity prescription.
Experimental periods: Each exercise session is preceded by a pre-exercise capillary CK sample and PPT assessment. Participants return 24h later for post-exercise CK and PPT. Before, during and/or immediately after exercise, heart rate (HR) and blood lactate are recorded. The rating of perceived exertion (RPE) is recorded 10 minutes after exercise. Daily online monitoring of muscle symptoms and recovery needs is performed throughout the study.
Outcome Measures Primary: Change in serum CK from pre- to 24h post-exercise (ΔCK).
Secondary: Change in PPT from pre- to 24h post-exercise (ΔPPT), change in blood lactate pre- to post-exercise, average HR during exercise, session-RPE, subjective recovery need (questionnaire) 24 hours after exercise.
Target Sample Size 40 participants (20 per group).
Statistical Analysis Linear mixed model with fixed effects: medication (statin vs. control), exercise intensity (END, RT1, RT2, RT3), and their interaction (main research question). Pre-exercise values as covariates; random intercept for subject. No time trend included as focus is on acute responses.
Ethics and Data Management All procedures follow preventive exercise guidelines. Participants benefit from supervised training and receive post-study exercise recommendations. Data are pseudonymized, stored within the European Union, and GDPR-compliant. Capillary sampling from the earlobe minimizes risks (only minor swelling/bruising possible).
Study Duration Total data acquisition <15 months; experimental phase per participant <4 months.
- Conditions
- Statin Adverse Reaction
- Being tested
- Dose-Escalation Exercise Protocol
- Keywords
- Statin, Statin-associated muscle symptoms, SAMS, Resistance training, Endurance training, Muscle loading, Creatine kinase, Recovery need, Exercise intensity
- Medical subject headings
- Short Stature, Auditory Canal Atresia, Mandibular Hypoplasia, Skeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-Escalation Exercise ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Statin-users (STN) | Experimental | stable statin therapy ≥8 weeks Receives: Other: Dose-Escalation Exercise Protocol |
| Statin-naïve controls (CON) | Active comparator | matched to STN Receives: Other: Dose-Escalation Exercise Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatine kinase (CK) level from pre-exercise to 24 hours post-exercise
Serum CK will be measured from capillary blood samples drawn from the earlobe. The outcome measure is the calculated change from the pre-exercise baseline value to the value obtained 24 hours after each exercise session.
Measured: Baseline and 24 hours post-exercise
Secondary outcomes (5)
Change in pressure pain threshold (PPT) from pre-exercise to 24 hours post-exercise
PPT will be measured using a handheld algometer with a 1-cm² probe on the rectus femoris. The outcome is the change from the pre-exercise baseline value to the value obtained 24 hours after each exercise session.
Measured: Baseline and 24 hours post-exercise
Heart rate (HR) during exercise
HR will be measured continuously in beats per minute during the entire exercise session. The outcome measure will be the average heart rate sustained over the duration of the session.
Measured: Continuous during each exercise session (from the start to the end of each endurance and resistance training session).
Blood lactate concentration before and after exercise
Blood lactate concentration will be measured from capillary blood samples drawn from the earlobe before and after each exercise session. The outcome is the change from the pre-exercise baseline value to the value obtained immediately after each exercise session.
Measured: Before the start and immediately after each endurance and resistance training session.
Subjective Need for Recovery after exercise (questionnaire)
Subjective sensation of the need for recovery will be quantified using a validated questionnaire. The specific questionnaire and its scoring range (minimum and maximum values) will be entered in the results reporting phase. Higher scores indicate a greater need for recovery.
Measured: Questionnaires will be collected daily to enable intra-individual robust scaling. However, the analysis will focus on recovery needs 24 hours post-exercise.
Session rating of perceived exertion (RPE)
Participants will rate their overall RPE for the entire exercise session using the Borg CR-10 scale. Scores range from 0 (no exertion at all) to 10 (maximal exertion). Session-RPE will be calculated by multiplying the RPE score by the duration of each exercise session.
Measured: RPE will be measured 10 minutes after the end of each endurance and resistance training session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start8 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Statin Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two parallel groups: STN and CON. CON are matched to STN by sex, age (±2 years), and BMI (±2 kg/m²). Allocation is non-randomized due to the nature of the exposure (statin medication status). Both groups undergo the same four acute exercise periods with dose escalation (END, RT1, RT2, RT3), each replicated twice, with a 5-21 day wash-out between sessions. Fixed order (non-randomized) for ethical/safety reasons; familiarization and intermittent strength testing calibrate intensity.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raffaele Mazzolari
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaet Innsbruck
- Responsible party
- Sponsor-investigator, Raffaele Mazzolari, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563452
- Sponsor's protocol ID
- 1098/2025
- Acronym
- STN-EX
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Rendered code will be shared, and IPD data might not be available due to privacy constraints.
Publications
Ruscica M, Ferri N, Banach M, Sirtori CR, Corsini A. Side effects of statins: from pathophysiology and epidemiology to diagnostic and therapeutic implications. Cardiovasc Res. 2023 Jan 18;118(17):3288-3304. doi: 10.1093/cvr/cvac020.
PubMed 35238338Sinzinger H, O'Grady J. Professional athletes suffering from familial hypercholesterolaemia rarely tolerate statin treatment because of muscular problems. Br J Clin Pharmacol. 2004 Apr;57(4):525-8. doi: 10.1111/j.1365-2125.2003.02044.x.
PubMed 15025753Hoppstadter J, Valbuena Perez JV, Linnenberger R, Dahlem C, Legroux TM, Hecksteden A, Tse WKF, Flamini S, Andreas A, Herrmann J, Herr C, Muller R, Meyer T, Bals R, Riccardi C, Bruscoli S, Kiemer AK. The glucocorticoid-induced leucine zipper mediates statin-induced muscle damage. FASEB J. 2020 Mar;34(3):4684-4701. doi: 10.1096/fj.201902557RRR. Epub 2020 Feb 6.
PubMed 32030813Hecksteden A, Hoppstadter J, Bizjak DA, Jerg A, Kirsten J, Kruger K, Niess A, Steinacker J, Kiemer AK. Effects of acute exercise and training status on glucocorticoid-induced leucine zipper (GILZ) expression in human skeletal muscle. J Sci Med Sport. 2023 Dec;26(12):707-710. doi: 10.1016/j.jsams.2023.10.007. Epub 2023 Oct 21.
PubMed 37951824Paul S, Donath L, Hoppstadter J, Hecksteden A. Resistance but not endurance training suppresses glucocorticoid-induced leucine zipper (GILZ) expression in human skeletal muscle. Eur J Appl Physiol. 2025 Apr;125(4):1023-1036. doi: 10.1007/s00421-024-05644-7. Epub 2024 Nov 5.
PubMed 39499305Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Moreno-Cabanas A, Mora-Rodriguez R. Exercise Training Adaptations in Metabolic Syndrome Individuals on Chronic Statin Treatment. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz304. doi: 10.1210/clinem/dgz304.
PubMed 31875915Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, Roden M, Stein E, Tokgozoglu L, Nordestgaard BG, Bruckert E, De Backer G, Krauss RM, Laufs U, Santos RD, Hegele RA, Hovingh GK, Leiter LA, Mach F, Marz W, Newman CB, Wiklund O, Jacobson TA, Catapano AL, Chapman MJ, Ginsberg HN; European Atherosclerosis Society Consensus Panel. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J. 2015 May 1;36(17):1012-22. doi: 10.1093/eurheartj/ehv043. Epub 2015 Feb 18.
PubMed 25694464Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.
PubMed 23583255Parker BA, Augeri AL, Capizzi JA, Ballard KD, Troyanos C, Baggish AL, D'Hemecourt PA, Thompson PD. Effect of statins on creatine kinase levels before and after a marathon run. Am J Cardiol. 2012 Jan 15;109(2):282-7. doi: 10.1016/j.amjcard.2011.08.045. Epub 2011 Oct 28.
PubMed 22036108Kearns AK, Bilbie CL, Clarkson PM, White CM, Sewright KA, O'Fallon KS, Gadarla M, Thompson PD. The creatine kinase response to eccentric exercise with atorvastatin 10 mg or 80 mg. Atherosclerosis. 2008 Sep;200(1):121-5. doi: 10.1016/j.atherosclerosis.2007.12.029. Epub 2008 Feb 7.
PubMed 18261731Laufs U, Filipiak KJ, Gouni-Berthold I, Catapano AL; SAMS expert working group. Practical aspects in the management of statin-associated muscle symptoms (SAMS). Atheroscler Suppl. 2017 Apr;26:45-55. doi: 10.1016/S1567-5688(17)30024-7.
PubMed 28434484
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Mechanical Muscle Loading in the Context of Preventive Exercise for Statin Users - a Pilot Study
- ClinicalTrials.gov ID
- NCT07563452
- Acronym / sponsor ID
- STN-EX / 1098/2025
- Conditions
- Statin Adverse Reaction
- Keywords
- Statin, Statin-associated muscle symptoms, SAMS, Resistance training, Endurance training, Muscle loading, Creatine kinase, Recovery need
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Raffaele MazzolariUniversity, hospital or other
- Collaborators
- Universitaet Innsbruck
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design This is a matched-pairs, non-randomized, dose-escalation exercise trial with within-subject replication. Statin users (STN) and statin-naïve controls (CON) are matched by sex, age (±2 years), and body mass index (BMI) (±2 kg/m²). Due to ethical and safety reasons (risk of injury in untrained individuals exposed to high-intensity resistance exercise), the order of experimental periods is fixed: all participants begin with endurance exercise (lowest muscle strain), then progress to resistance training at 40%, 60%, and 80% of e1RM.
Interventions Endurance training sessions (END): 40 minutes cycling at 60% heart rate reserve (HRR), plus 5 min warm-up and cool-down.
Resistance training sessions (RT1-RT3): 8 machine-based exercises (e.g., leg press, chest press, lat pull-down). Two sets per exercise, repetitions decrease with intensity (20 reps at 40% e1RM, 12 reps at 60%, 8 reps at 80%). Rest between sets ~120 sec. Each intensity period includes two identical sessions, separated by a 5-21-day washout.
Procedures Screening: Medical history, physical exam, resting electrocardiogram (ECG), cardiopulmonary exercise test (CPET).
Baseline: Two measurements of CK from capillary blood and pressure pain threshold (PPT) on the rectus femoris.
Familiarization: Two low-intensity RT sessions to teach correct technique and breathing.
10-repetition maximum (10RM) testing: For each RT exercise, participants perform up to three attempts to find the maximal load for 10 controlled repetitions; then e1RM is calculated for intensity prescription.
Experimental periods: Each exercise session is preceded by a pre-exercise capillary CK sample and PPT assessment. Participants return 24h later for post-exercise CK and PPT. Before, during and/or immediately after exercise, heart rate (HR) and blood lactate are recorded. The rating of perceived exertion (RPE) is recorded 10 minutes after exercise. Daily online monitoring of muscle symptoms and recovery needs is performed throughout the study.
Outcome Measures Primary: Change in serum CK from pre- to 24h post-exercise (ΔCK).
Secondary: Change in PPT from pre- to 24h post-exercise (ΔPPT), change in blood lactate pre- to post-exercise, average HR during exercise, session-RPE, subjective recovery need (questionnaire) 24 hours after exercise.
Target Sample Size 40 participants (20 per group).
Statistical Analysis Linear mixed model with fixed effects: medication (statin vs. control), exercise intensity (END, RT1, RT2, RT3), and their interaction (main research question). Pre-exercise values as covariates; random intercept for subject. No time trend included as focus is on acute responses.
Ethics and Data Management All procedures follow preventive exercise guidelines. Participants benefit from supervised training and receive post-study exercise recommendations. Data are pseudonymized, stored within the European Union, and GDPR-compliant. Capillary sampling from the earlobe minimizes risks (only minor swelling/bruising possible).
Study Duration Total data acquisition <15 months; experimental phase per participant <4 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to two parallel groups: STN and CON. CON are matched to STN by sex, age (±2 years), and BMI (±2 kg/m²). Allocation is non-randomized due to the nature of the exposure (statin medication status). Both groups undergo the same four acute exercise periods with dose escalation (END, RT1, RT2, RT3), each replicated twice, with a 5-21 day wash-out between sessions. Fixed order (non-randomized) for ethical/safety reasons; familiarization and intermittent strength testing calibrate intensity.
| Arm | Type | Receives |
|---|---|---|
| Statin-users (STN) | Experimental | Other: Dose-Escalation Exercise Protocolstable statin therapy ≥8 weeks |
| Statin-naïve controls (CON) | Active comparator | Other: Dose-Escalation Exercise Protocolmatched to STN |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose-Escalation Exercise ProtocolA 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. | Other | Statin-naïve controls (CON), Statin-users (STN) |
Primary outcome
Change in serum creatine kinase (CK) level from pre-exercise to 24 hours post-exercise
Time frame: Baseline and 24 hours post-exercise
Serum CK will be measured from capillary blood samples drawn from the earlobe. The outcome measure is the calculated change from the pre-exercise baseline value to the value obtained 24 hours after each exercise session.
5 secondary outcomes
Change in pressure pain threshold (PPT) from pre-exercise to 24 hours post-exercise
Time frame: Baseline and 24 hours post-exercise
Heart rate (HR) during exercise
Time frame: Continuous during each exercise session (from the start to the end of each endurance and resistance training session).
Blood lactate concentration before and after exercise
Time frame: Before the start and immediately after each endurance and resistance training session.
Subjective Need for Recovery after exercise (questionnaire)
Time frame: Questionnaires will be collected daily to enable intra-individual robust scaling. However, the analysis will focus on recovery needs 24 hours post-exercise.
Session rating of perceived exertion (RPE)
Time frame: RPE will be measured 10 minutes after the end of each endurance and resistance training session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 35238338Ruscica M, Ferri N, Banach M, Sirtori CR, Corsini A. Side effects of statins: from pathophysiology and epidemiology to diagnostic and therapeutic implications. Cardiovasc Res. 2023 Jan 18;118(17):3288-3304. doi: 10.1093/cvr/cvac020.
- Background: PubMed 15025753Sinzinger H, O'Grady J. Professional athletes suffering from familial hypercholesterolaemia rarely tolerate statin treatment because of muscular problems. Br J Clin Pharmacol. 2004 Apr;57(4):525-8. doi: 10.1111/j.1365-2125.2003.02044.x.
- Background: PubMed 32030813Hoppstadter J, Valbuena Perez JV, Linnenberger R, Dahlem C, Legroux TM, Hecksteden A, Tse WKF, Flamini S, Andreas A, Herrmann J, Herr C, Muller R, Meyer T, Bals R, Riccardi C, Bruscoli S, Kiemer AK. The glucocorticoid-induced leucine zipper mediates statin-induced muscle damage. FASEB J. 2020 Mar;34(3):4684-4701. doi: 10.1096/fj.201902557RRR. Epub 2020 Feb 6.
- Background: PubMed 37951824Hecksteden A, Hoppstadter J, Bizjak DA, Jerg A, Kirsten J, Kruger K, Niess A, Steinacker J, Kiemer AK. Effects of acute exercise and training status on glucocorticoid-induced leucine zipper (GILZ) expression in human skeletal muscle. J Sci Med Sport. 2023 Dec;26(12):707-710. doi: 10.1016/j.jsams.2023.10.007. Epub 2023 Oct 21.
- Background: PubMed 39499305Paul S, Donath L, Hoppstadter J, Hecksteden A. Resistance but not endurance training suppresses glucocorticoid-induced leucine zipper (GILZ) expression in human skeletal muscle. Eur J Appl Physiol. 2025 Apr;125(4):1023-1036. doi: 10.1007/s00421-024-05644-7. Epub 2024 Nov 5.
- Background: PubMed 31875915Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Moreno-Cabanas A, Mora-Rodriguez R. Exercise Training Adaptations in Metabolic Syndrome Individuals on Chronic Statin Treatment. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz304. doi: 10.1210/clinem/dgz304.
- Background: PubMed 25694464Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, Roden M, Stein E, Tokgozoglu L, Nordestgaard BG, Bruckert E, De Backer G, Krauss RM, Laufs U, Santos RD, Hegele RA, Hovingh GK, Leiter LA, Mach F, Marz W, Newman CB, Wiklund O, Jacobson TA, Catapano AL, Chapman MJ, Ginsberg HN; European Atherosclerosis Society Consensus Panel. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J. 2015 May 1;36(17):1012-22. doi: 10.1093/eurheartj/ehv043. Epub 2015 Feb 18.
- Background: PubMed 23583255Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.
- Background: PubMed 22036108Parker BA, Augeri AL, Capizzi JA, Ballard KD, Troyanos C, Baggish AL, D'Hemecourt PA, Thompson PD. Effect of statins on creatine kinase levels before and after a marathon run. Am J Cardiol. 2012 Jan 15;109(2):282-7. doi: 10.1016/j.amjcard.2011.08.045. Epub 2011 Oct 28.
- Background: PubMed 18261731Kearns AK, Bilbie CL, Clarkson PM, White CM, Sewright KA, O'Fallon KS, Gadarla M, Thompson PD. The creatine kinase response to eccentric exercise with atorvastatin 10 mg or 80 mg. Atherosclerosis. 2008 Sep;200(1):121-5. doi: 10.1016/j.atherosclerosis.2007.12.029. Epub 2008 Feb 7.
- Background: PubMed 28434484Laufs U, Filipiak KJ, Gouni-Berthold I, Catapano AL; SAMS expert working group. Practical aspects in the management of statin-associated muscle symptoms (SAMS). Atheroscler Suppl. 2017 Apr;26:45-55. doi: 10.1016/S1567-5688(17)30024-7.
- Individual participant dataSharing planned: Undecided. Rendered code will be shared, and IPD data might not be available due to privacy constraints.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose-Escalation Exercise Protocol in people with Statin Adverse Reaction, run by Raffaele Mazzolari at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Mazzolari, Dr. (+393468754234, raffaele.mazzolari@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum creatine kinase (CK) level from pre-exercise to 24 hours post-exercise (time frame: Baseline and 24 hours post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07563452, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.