Physical Activity Levels and Statin Therapy

Radboud University Medical Center

Status: Completed

Conditions: HMG COA Reductase Inhibitor Adverse Reaction; Cardiovascular Diseases; Muscle Pain

Treatments: Behavioral: Physical activity monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT05625945

NL9196

Details and patient eligibility

About

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).

Objective: To identify predictors for SAMS in statin users and to objectively assess physical activity levels and sedentary time between symptomatic and asymptomatic statin users.

Full 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). Physical activity may exacerbate SAMS, producing decreased physical activity levels or statin nonadherence. However, it is unknown if daily activity patterns differ between symptomatic and asymptomatic statin users.

In this cross-sectional observational study the investigators will assess if physical activity levels and sedentary time differ between symptomatic and asymptomatic statins users. Secondly, questionnaires will be used to assess predictors of SAMS.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Known hereditary muscle defect
• Known mitochondrial disease
• Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)

Trial design

196 participants in 2 patient groups

Symptomatic statin users

Description:

Statin users with self-reported muscle symptoms

Treatment:

Behavioral: Physical activity monitoring

Asymptomatic statin users

Description:

Statin users without muscle symptoms

Treatment:

Behavioral: Physical activity monitoring