Physical Activity Levels and Statin Therapy

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05625945
• Other study ID #: NL9196
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: November 16, 2023

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HMG COA Reductase Inhibitor Adverse Reaction
• Muscle Pain
• Myalgia

Intervention

Behavioral:
• Physical activity monitoring
Physical activity patterns will be measured using the activPAL3 micro monitor

Locations

Country	Name	City	State
Netherlands	Department of Physiology	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Physical activity (min/day) will be assessed using the activPAL3 micro monitor	during 1 week
Primary	Sedentary time	Sedentary time (min/day) will be assessed using the activPAL3 micro monitor	during 1 week
Secondary	Predictors of statin-associated muscle complaints (SAMS)	Using questionnaires predictors of SAMS will be explored	1 moment (cross-sectional)