Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction, Muscle Damage
Conditions
Keywords
Statin-associated muscle symptoms, Muscle damage markers, Moderate-intensity exercise, Coenzyme Q10
Brief 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.
Interventions
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.
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Mentally able to give informed consent * Statin groups: statin treatment for at least 3 months
Exclusion criteria
* Known hereditary muscle defect * Known mitochondrial disease * Diabetes Mellitus * Hypo- or hyperthyroidism * Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases) * Coenzyme Q10 supplementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle damage markers | Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day) | Change in muscle damage markers (creatine kinase, myoglobin, lactate dehydrogenase, troponin I and BNP) from baseline to post-exercise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle pain scores | Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day) | Muscle pain scores measured with the Brief Pain Inventory questionnaire (10 point scale with 0 representing no pain and 10 the worst pain imaginable) |
| Muscle strength and fatigue | Baseline (before exercise) and after one day of moderate-intensity walking exercise | M. Quadriceps muscle strength and fatigue measured using electrical stimulation |
| Coenzyme Q10 levels | At baseline | Coenzyme Q10 levels measured in leukocytes |
Countries
Netherlands
Outcome results
None listed