Physical Activity Levels and Statin Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-11-16

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.

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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.

Conditions

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Cardiovascular Diseases HMG COA Reductase Inhibitor Adverse Reaction Muscle Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Symptomatic statin users

Statin users with self-reported muscle symptoms

Physical activity monitoring

Intervention Type BEHAVIORAL

Physical activity patterns will be measured using the activPAL3 micro monitor

Asymptomatic statin users

Statin users without muscle symptoms

Physical activity monitoring

Intervention Type BEHAVIORAL

Physical activity patterns will be measured using the activPAL3 micro monitor

Interventions

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Physical activity monitoring

Physical activity patterns will be measured using the activPAL3 micro monitor

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No