Exercise-induced Muscle Damage in Statin Users

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011643
• Other study ID #: CMO 2007-148
• Status: Completed
• Start date: May 29, 2018
• Est. completion date: July 20, 2018

Study information

• Verified date: August 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HMG COA Reductase Inhibitor Adverse Reaction
• Muscle Damage

Intervention

Other:
• Moderate-intensity exercise
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.

Locations

Country	Name	City	State
Netherlands	Department of Physiology	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle damage markers	Change in muscle damage markers (creatine kinase, myoglobin, lactate dehydrogenase, troponin I and BNP) from baseline to post-exercise	Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)
Secondary	Muscle pain scores	Muscle pain scores measured with the Brief Pain Inventory questionnaire (10 point scale with 0 representing no pain and 10 the worst pain imaginable)	Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)
Secondary	Muscle strength and fatigue	M. Quadriceps muscle strength and fatigue measured using electrical stimulation	Baseline (before exercise) and after one day of moderate-intensity walking exercise
Secondary	Coenzyme Q10 levels	Coenzyme Q10 levels measured in leukocytes	At baseline