Physical Activity Levels and Statin Therapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05625945

Enrollment

196

Registered

2022-11-23

Start date

2021-01-01

Completion date

2023-11-16

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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

BEHAVIORALPhysical activity monitoring

Physical activity patterns will be measured using the activPAL3 micro monitor

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026