Exercise-induced Muscle Damage in Statin Users
Condition: Cardiovascular Diseases; HMG COA Reductase Inhibitor Adverse Reaction; Muscle Damage
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Rationale: Combining statin treatment and physical activity is very effective for the
      prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may
      cause statin-associated muscle symptoms (SAMS) and elevated markers of skeletal muscle damage
      in some patients.

      Several studies have shown that statins augment increases in serum creatine kinase after
      eccentric or vigorous exercise. If statins also increase muscle damage markers after
      exercises of moderate intensity is unclear. Symptomatic statin users may be more susceptible
      to exercise-induced skeletal muscle injury, however, previous studies did not differentiate
      between symptomatic and asymptomatic statin users.

      Objective: To compare the impact of moderate-intensity exercise on muscle damage markers
      between symptomatic and asymptomatic statin users, and non-statin using controls. A secondary
      objective is to examine the association between leukocytes coenzyme Q10 levels and
      exercise-induced muscle damage and muscle complaints.
    

Detailed description: 
      Combining statin treatment and physical activity is very effective for the prevention of
      cardiovascular diseases. Statins are well-tolerated by most patients, but may cause
      statin-associated muscle symptoms (SAMS) and elevated markers of skeletal muscle damage in
      some patients.

      Several studies have shown that statins augment increases in serum creatine kinase after
      eccentric or vigorous exercise. However. if statins also increase muscle damage markers after
      exercises of moderate intensity is unclear. Impaired mitochondrial oxidative function might
      contribute to SAMS and exercise-induced muscle damage. Several studies showed that statins
      decrease serum coenzyme Q10 levels, an essential component of the mitochondrial transport
      chain, but effects on intramuscular coenzyme Q10 levels are inconsistent. The investigators
      have observed that mitochondrial dysfunction is more pronounced in statin users with SAMS
      compared to asymptomatic statin users. This suggests that symptomatic statin users may be
      more susceptible to exercise-induced skeletal muscle injury. However, previous studies
      examining creatine kinase response to exercise did not differentiate between symptomatic and
      asymptomatic statin users.

      In this cross-sectional observational study the investigators will study the impact of
      moderate-intensity exercise on muscle damage markers between symptomatic and asymptomatic
      statin users, and non-statin using controls. A secondary objective is to examine the
      association between leukocytes coenzyme Q10 levels and exercise-induced muscle damage and
      muscle complaints.

      The investigators hypothesize that statins will not increase muscle damage markers after
      moderate-intensity exercise and that higher CoQ10 levels are associated with less
      exercise-induced muscle damage and muscle complaints.
    

Intervention name(s): Moderate-intensity exercise
Intervention type(s): Other
Intervention description(s): Participants will walk either 30km, 40km or 50km for four consecutive days during the Nijmegen Four Days Marches. Measurements will be performed after the finish of the first, second and third walking day.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Symptomatic statin users (n=35), asymptomatic statin users (n=34) and non-statin using
        controls (n=31).
      
Biospecimen description: 
      Blood samples to analyze muscle damage markers
    
Keywords: Statin-associated muscle symptoms; Muscle damage markers; Moderate-intensity exercise; Coenzyme Q10