Physical Activity Levels and Statin Therapy

Overview

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 Title of Study: “Physical Activity Levels and Statin Therapy: Differences Between Symptomatic and Asymptomatic Statin Users”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: August 1, 2021

Detailed 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.

Interventions

  • Behavioral: Physical activity monitoring
    • Physical activity patterns will be measured using the activPAL3 micro monitor

Arms, Groups and Cohorts

  • Symptomatic statin users
    • Statin users with self-reported muscle symptoms
  • Asymptomatic statin users
    • Statin users without muscle symptoms

Clinical Trial Outcome Measures

Primary Measures

  • Physical activity
    • Time Frame: during 1 week
    • Physical activity (min/day) will be assessed using the activPAL3 micro monitor
  • Sedentary time
    • Time Frame: during 1 week
    • Sedentary time (min/day) will be assessed using the activPAL3 micro monitor

Secondary Measures

  • Predictors of statin-associated muscle complaints (SAMS)
    • Time Frame: 1 moment (cross-sectional)
    • Using questionnaires predictors of SAMS will be explored

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radboud University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor

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