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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05625945
Other study ID # NL9196
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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