NCT05011643

Exercise-induced Muscle Damage in Statin Users

Completed Last updated 27 August 2021

What this trial tests

trial testing Moderate-intensity exercise in Cardiovascular Diseases in 100 participants. Completed in 20 July 2018.

Timeline

29 May 2018

Primary endpoint
20 July 2018

20 July 2018

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	29 May 2018
Primary completion	20 July 2018
Estimated completion	20 July 2018
Sites	1 location across Netherlands

Drugs / interventions tested

• Moderate-intensity exercise

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• HMG COA Reductase Inhibitor Adverse Reaction — all drugs for HMG COA Reductase Inhibitor Adverse Reaction →
• Muscle Damage — all drugs for Muscle Damage →

Sponsor

Radboud University Medical Center

Who can join

Adults 40 to 75, any sex, with Cardiovascular Diseases or HMG COA Reductase Inhibitor Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prolonged Moderate-Intensity Exercise Does Not Increase Muscle Injury Markers in Symptomatic or Asymptomatic Statin Users.
   Allard NAE, Janssen L, Lagerwaard B, Nuijten MAH, et al · · 2023 · cited 8× · PMID 37019582 · DOI 10.1016/j.jacc.2023.01.043
2. Mitochondrial complex III activity: from invasive muscle biopsies to patient-friendly buccal swab analysis.
   Somers T, Allard NAE, Siddiqi S, Janssen MCM, et al · · 2023 · cited 1× · PMID 37316639 · DOI 10.1038/s41598-023-36741-w