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OpenTrials
Completed

NCT Number: NCT05625945

Physical Activity Levels and Statin Therapy

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.

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Key information

Conditions

Cardiovascular Diseases HMG COA Reductase Inhibitor Adverse Reaction Muscle Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physiology

Nijmegen, 6525 EX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physical activity monitoring

Behavioral

Physical activity patterns will be measured using the activPAL3 micro monitor

Primary outcomes

  1. Physical activity

    Time frame: during 1 week

    Physical activity (min/day) will be assessed using the activPAL3 micro monitor

  2. Sedentary time

    Time frame: during 1 week

    Sedentary time (min/day) will be assessed using the activPAL3 micro monitor

Secondary outcomes

  1. Predictors of statin-associated muscle complaints (SAMS)

    Time frame: 1 moment (cross-sectional)

    Using questionnaires predictors of SAMS will be explored

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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