NCT05625945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

October 23, 2022

Last Update Submit

November 17, 2023

Conditions

Cardiovascular DiseasesHMG COA Reductase Inhibitor Adverse ReactionMuscle Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Predictors of statin-associated muscle complaints (SAMS)

    1 moment (cross-sectional)

Study Arms (2)

Symptomatic statin users

Statin users with self-reported muscle symptoms

Behavioral: Physical activity monitoring

Asymptomatic statin users

Statin users without muscle symptoms

Behavioral: Physical activity monitoring

Interventions

Physical activity monitoringBEHAVIORAL

Physical activity patterns will be measured using the activPAL3 micro monitor

Asymptomatic statin usersSymptomatic statin users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Mentally able to give informed consent
  • Statin treatment for at least 3 months

You may not qualify if:

  • Known hereditary muscle defect
  • Known mitochondrial disease
  • Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiology

Nijmegen, 6525 EX, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular DiseasesMyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2022

First Posted

November 23, 2022

Study Start

January 1, 2021

Primary Completion

November 16, 2023

Study Completion

November 16, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)