Exercise-induced Muscle Damage in Statin Users

NCT05011643 | Completed

• 1 other identifier: CMO 2007-148
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Statin-associated muscle symptoms; Muscle damage markers; Moderate-intensity exercise; Coenzyme Q10

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Muscle pain scores

  Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)

• Muscle strength and fatigue

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

• Coenzyme Q10 levels

  At baseline

Study Arms (3)

Symptomatic statin users

Statin users with self-reported muscle symptoms

Other: Moderate-intensity exercise

Asymptomatic statin users

Statin users without muscle symptoms

Other: Moderate-intensity exercise

Non-statin using controls

Participants not using statins

Other: Moderate-intensity exercise

Interventions

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.

Asymptomatic statin users; Non-statin using controls; Symptomatic statin users

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic statin users (n=35), asymptomatic statin users (n=34) and non-statin using controls (n=31).

You may qualify if:

• Mentally able to give informed consent
• Statin groups: statin treatment for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Physiology

Nijmegen, 6525 EX, Netherlands

Location

Related Publications (1)

• Allard NAE, Janssen L, Lagerwaard B, Nuijten MAH, Bongers CCWG, Rodenburg RJ, Thompson PD, Eijsvogels TMH, Assendelft WJJ, Schirris TJJ, Timmers S, Hopman MTE. Prolonged Moderate-Intensity Exercise Does Not Increase Muscle Injury Markers in Symptomatic or Asymptomatic Statin Users. J Am Coll Cardiol. 2023 Apr 11;81(14):1353-1364. doi: 10.1016/j.jacc.2023.01.043.

  PMID: 37019582 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to analyze muscle damage markers

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 18, 2021
• Study Start: May 29, 2018
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)