Physical Activity Levels and Statin Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Physical Activity Levels and Statin Therapy: Differences Between Symptomatic and Asymptomatic Statin Users

Conditions
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Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction, Muscle Pain

Intervention / Treatment
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* Behavioral: Physical activity monitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic statin users<br>Statin users with self-reported muscle symptoms | Behavioral: Physical activity monitoring<br>* Physical activity patterns will be measured using the activPAL3 micro monitor<br>|
| Asymptomatic statin users<br>Statin users without muscle symptoms | Behavioral: Physical activity monitoring<br>* Physical activity patterns will be measured using the activPAL3 micro monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Physical activity (min/day) will be assessed using the activPAL3 micro monitor | during 1 week | 
| Sedentary time | Sedentary time (min/day) will be assessed using the activPAL3 micro monitor | during 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of statin-associated muscle complaints (SAMS) | Using questionnaires predictors of SAMS will be explored | 1 moment (cross-sectional) |