Physical Activity Levels and Statin Therapy

Sponsor

Radboud University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05625945

Collaborator

(none)

200

Enrollment

Location

25.9

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases HMG COA Reductase Inhibitor Adverse Reaction Muscle Pain	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Physiology	Nijmegen		Netherlands	6525 EX

Sponsors and Collaborators

Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT05625945

Other Study ID Numbers:

NL9196

First Posted:

Nov 23, 2022

Last Update Posted:

Nov 23, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myalgia

Cardiovascular Diseases

Study Results

No Results Posted as of Nov 23, 2022