Cardiovascular Diseases Clinical Trial
Official title:
Physical Activity Levels and Statin Therapy: Differences Between Symptomatic and Asymptomatic Statin Users
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 |
Verified date | November 2023 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Physiology | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
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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