Physical Activity Levels and Statin Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Muscle Pain; HMG COA Reductase Inhibitor Adverse Reaction
• Intervention / Treatment: Behavioral: Physical activity monitoring

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 Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525 EX
    • Department of Physiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic statin users (n=100) and asymptomatic statin users (n=100)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic statin users; Statin users with self-reported muscle symptoms	Behavioral: Physical activity monitoring; Physical activity patterns will be measured using the activPAL3 micro monitor
Asymptomatic statin users; Statin users without muscle symptoms	Behavioral: Physical activity monitoring; Physical activity patterns will be measured using the activPAL3 micro monitor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Cardiovascular Diseases; Myalgia
• Other Study ID Numbers: NL9196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No