Cardiovascular DiseasesNCT05625945
Physical Activity Levels and Statin Therapy
An observational study of Cardiovascular Diseases and HMG COA Reductase Inhibitor Adverse Reaction, run by Radboud University Medical Center at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction, Muscle Pain
- What is being tested?
- Physical activity monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 196 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2021to 16 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic statin users (n=100) and asymptomatic statin users (n=100)
Who may be able to join
- Mentally able to give informed consent
- Statin treatment for at least 3 months
Who cannot join
- Known hereditary muscle defect
- Known mitochondrial disease
- Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity Levels and Statin Therapy: Differences Between Symptomatic and Asymptomatic Statin Users
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.
Read the 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.
- Being tested
- Physical activity monitoring
- Medical subject headings
- Cardiovascular Diseases, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity monitoringBehavioural
Physical activity patterns will be measured using the activPAL3 micro monitor
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic statin users | Statin users with self-reported muscle symptoms Receives: Behavioral: Physical activity monitoring | |
| Asymptomatic statin users | Statin users without muscle symptoms Receives: Behavioral: Physical activity monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Physical activity (min/day) will be assessed using the activPAL3 micro monitor
Measured: during 1 week
Sedentary time
Sedentary time (min/day) will be assessed using the activPAL3 micro monitor
Measured: during 1 week
Secondary outcomes (1)
Predictors of statin-associated muscle complaints (SAMS)
Using questionnaires predictors of SAMS will be explored
Measured: 1 moment (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Jan 2021
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625945
- Sponsor's protocol ID
- NL9196
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Levels and Statin Therapy: Differences Between Symptomatic and Asymptomatic Statin Users
- ClinicalTrials.gov ID
- NCT05625945
- Acronym / sponsor ID
- NL9196
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic statin users | – | Behavioral: Physical activity monitoringStatin users with self-reported muscle symptoms |
| Asymptomatic statin users | – | Behavioral: Physical activity monitoringStatin users without muscle symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic statin users (n=100) and asymptomatic statin users (n=100)
Key inclusion criteria (2 listed)
- Mentally able to give informed consent
- Statin treatment for at least 3 months
Key exclusion criteria (3 listed)
- Known hereditary muscle defect
- Known mitochondrial disease
- Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity monitoringPhysical activity patterns will be measured using the activPAL3 micro monitor | Behavioural | Asymptomatic statin users, Symptomatic statin users |
Primary outcome
Physical activity
Time frame: during 1 week
Physical activity (min/day) will be assessed using the activPAL3 micro monitor
Sedentary time
Time frame: during 1 week
Sedentary time (min/day) will be assessed using the activPAL3 micro monitor
1 secondary outcome
Predictors of statin-associated muscle complaints (SAMS)
Time frame: 1 moment (cross-sectional)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and HMG COA Reductase Inhibitor Adverse Reaction, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: during 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.