Physical Activity Levels and Statin Therapy

Completed

• Conditions: Cardiovascular Diseases; HMG COA Reductase Inhibitor Adverse Reaction; Muscle Pain
• Interventions: Behavioral: Physical activity monitoring

• Registration Number: NCT05625945
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Status Verified: 2023-11
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic statin users	Physical activity monitoring	Statin users with self-reported muscle symptoms
Asymptomatic statin users	Physical activity monitoring	Statin users without muscle symptoms

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Physiology; 🇳🇱 Nijmegen, Netherlands