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Completed

NCT Number: NCT05011643

Exercise-induced Muscle Damage in Statin Users

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.

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Key information

Conditions

Cardiovascular Diseases HMG COA Reductase Inhibitor Adverse Reaction Muscle Damage

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physiology

Nijmegen, 6525 EX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate-Intensity Exercise

Other

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.

Primary outcomes

  1. Muscle damage markers

    Time frame: 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 outcomes

  1. Muscle pain scores

    Time frame: 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)

  2. Muscle strength and fatigue

    Time frame: Baseline (before exercise) and after one day of moderate-intensity walking exercise

    M. Quadriceps muscle strength and fatigue measured using electrical stimulation

  3. Coenzyme Q10 levels

    Time frame: At baseline

    Coenzyme Q10 levels measured in leukocytes

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Effects of Statins on Muscle Damage Markers After Moderate-intensity Exercise

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2021
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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