Cardiovascular DiseasesNCT05011643
Exercise-induced Muscle Damage in Statin Users
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) and elevated markers of skeletal muscle damage in some patients. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction, Muscle Damage
- What is being tested?
- Moderate-intensity exercise
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 May 2018to 20 Jul 2018
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Symptomatic statin users (n=35), asymptomatic statin users (n=34) and non-statin using controls (n=31).
Who may be able to join
- Mentally able to give informed consent
- Statin groups: statin treatment for at least 3 months
Who cannot join
- Known hereditary muscle defect
- Known mitochondrial disease
- Diabetes Mellitus
- Hypo- or hyperthyroidism
- Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)
- Coenzyme Q10 supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Statins on Muscle Damage Markers After Moderate-intensity Exercise
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) and elevated markers of skeletal muscle damage in some patients.
Several studies have shown that statins augment increases in serum creatine kinase after eccentric or vigorous exercise. If statins also increase muscle damage markers after exercises of moderate intensity is unclear. Symptomatic statin users may be more susceptible to exercise-induced skeletal muscle injury, however, previous studies did not differentiate between symptomatic and asymptomatic statin users.
Objective: To compare the impact of moderate-intensity exercise on muscle damage markers between symptomatic and asymptomatic statin users, and non-statin using controls. A secondary objective is to examine the association between leukocytes coenzyme Q10 levels and exercise-induced muscle damage and muscle complaints.
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) and elevated markers of skeletal muscle damage in some patients.
Several studies have shown that statins augment increases in serum creatine kinase after eccentric or vigorous exercise. However. if statins also increase muscle damage markers after exercises of moderate intensity is unclear. Impaired mitochondrial oxidative function might contribute to SAMS and exercise-induced muscle damage. Several studies showed that statins decrease serum coenzyme Q10 levels, an essential component of the mitochondrial transport chain, but effects on intramuscular coenzyme Q10 levels are inconsistent. The investigators have observed that mitochondrial dysfunction is more pronounced in statin users with SAMS compared to asymptomatic statin users. This suggests that symptomatic statin users may be more susceptible to exercise-induced skeletal muscle injury. However, previous studies examining creatine kinase response to exercise did not differentiate between symptomatic and asymptomatic statin users.
In this cross-sectional observational study the investigators will study the impact of moderate-intensity exercise on muscle damage markers between symptomatic and asymptomatic statin users, and non-statin using controls. A secondary objective is to examine the association between leukocytes coenzyme Q10 levels and exercise-induced muscle damage and muscle complaints.
The investigators hypothesize that statins will not increase muscle damage markers after moderate-intensity exercise and that higher CoQ10 levels are associated with less exercise-induced muscle damage and muscle complaints.
- Being tested
- Moderate-intensity exercise
- Keywords
- Statin-associated muscle symptoms, Muscle damage markers, Moderate-intensity exercise, Coenzyme Q10
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity exerciseOther
Participants will walk either 30km, 40km or 50km for four consecutive days during the Nijmegen Four Days Marches. Measurements will be performed after the finish of the first, second and third walking day.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic statin users | Statin users with self-reported muscle symptoms Receives: Other: Moderate-intensity exercise | |
| Asymptomatic statin users | Statin users without muscle symptoms Receives: Other: Moderate-intensity exercise | |
| Non-statin using controls | Participants not using statins Receives: Other: Moderate-intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle damage markers
Change in muscle damage markers (creatine kinase, myoglobin, lactate dehydrogenase, troponin I and BNP) from baseline to post-exercise
Measured: Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)
Secondary outcomes (3)
Muscle pain scores
Muscle pain scores measured with the Brief Pain Inventory questionnaire (10 point scale with 0 representing no pain and 10 the worst pain imaginable)
Measured: Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)
Muscle strength and fatigue
- Quadriceps muscle strength and fatigue measured using electrical stimulation
Measured: Baseline (before exercise) and after one day of moderate-intensity walking exercise
Coenzyme Q10 levels
Coenzyme Q10 levels measured in leukocytes
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start29 May 2018
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 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
- NCT05011643
- Sponsor's protocol ID
- CMO 2007-148
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allard NAE, Janssen L, Lagerwaard B, Nuijten MAH, Bongers CCWG, Rodenburg RJ, Thompson PD, Eijsvogels TMH, Assendelft WJJ, Schirris TJJ, Timmers S, Hopman MTE. Prolonged Moderate-Intensity Exercise Does Not Increase Muscle Injury Markers in Symptomatic or Asymptomatic Statin Users. J Am Coll Cardiol. 2023 Apr 11;81(14):1353-1364. doi: 10.1016/j.jacc.2023.01.043.
PubMed 37019582
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Statins on Muscle Damage Markers After Moderate-intensity Exercise
- ClinicalTrials.gov ID
- NCT05011643
- Acronym / sponsor ID
- CMO 2007-148
- Keywords
- Statin-associated muscle symptoms, Muscle damage markers, Moderate-intensity exercise, Coenzyme Q10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 18 Aug 2021 (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) and elevated markers of skeletal muscle damage in some patients.
Several studies have shown that statins augment increases in serum creatine kinase after eccentric or vigorous exercise. If statins also increase muscle damage markers after exercises of moderate intensity is unclear. Symptomatic statin users may be more susceptible to exercise-induced skeletal muscle injury, however, previous studies did not differentiate between symptomatic and asymptomatic statin users.
Objective: To compare the impact of moderate-intensity exercise on muscle damage markers between symptomatic and asymptomatic statin users, and non-statin using controls. A secondary objective is to examine the association between leukocytes coenzyme Q10 levels and exercise-induced muscle damage and muscle complaints.
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) and elevated markers of skeletal muscle damage in some patients.
Several studies have shown that statins augment increases in serum creatine kinase after eccentric or vigorous exercise. However. if statins also increase muscle damage markers after exercises of moderate intensity is unclear. Impaired mitochondrial oxidative function might contribute to SAMS and exercise-induced muscle damage. Several studies showed that statins decrease serum coenzyme Q10 levels, an essential component of the mitochondrial transport chain, but effects on intramuscular coenzyme Q10 levels are inconsistent. The investigators have observed that mitochondrial dysfunction is more pronounced in statin users with SAMS compared to asymptomatic statin users. This suggests that symptomatic statin users may be more susceptible to exercise-induced skeletal muscle injury. However, previous studies examining creatine kinase response to exercise did not differentiate between symptomatic and asymptomatic statin users.
In this cross-sectional observational study the investigators will study the impact of moderate-intensity exercise on muscle damage markers between symptomatic and asymptomatic statin users, and non-statin using controls. A secondary objective is to examine the association between leukocytes coenzyme Q10 levels and exercise-induced muscle damage and muscle complaints.
The investigators hypothesize that statins will not increase muscle damage markers after moderate-intensity exercise and that higher CoQ10 levels are associated with less exercise-induced muscle damage and muscle complaints.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic statin users | – | Other: Moderate-intensity exerciseStatin users with self-reported muscle symptoms |
| Asymptomatic statin users | – | Other: Moderate-intensity exerciseStatin users without muscle symptoms |
| Non-statin using controls | – | Other: Moderate-intensity exerciseParticipants not using statins |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic statin users (n=35), asymptomatic statin users (n=34) and non-statin using controls (n=31).
Key inclusion criteria (2 listed)
- Mentally able to give informed consent
- Statin groups: statin treatment for at least 3 months
Key exclusion criteria (6 listed)
- Known hereditary muscle defect
- Known mitochondrial disease
- Diabetes Mellitus
- Hypo- or hyperthyroidism
- 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 |
|---|---|---|
| Moderate-intensity exerciseParticipants will walk either 30km, 40km or 50km for four consecutive days during the Nijmegen Four Days Marches. Measurements will be performed after the finish of the first, second and third walking day. | Other | Asymptomatic statin users, Non-statin using controls, Symptomatic statin users |
Primary outcome
Muscle damage markers
Time frame: Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)
Change in muscle damage markers (creatine kinase, myoglobin, lactate dehydrogenase, troponin I and BNP) from baseline to post-exercise
3 secondary outcomes
Muscle pain scores
Time frame: Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)
Muscle strength and fatigue
Time frame: Baseline (before exercise) and after one day of moderate-intensity walking exercise
Coenzyme Q10 levels
Time frame: At baseline
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 27 Aug 2021.
- Derived from this study: PubMed 37019582Allard NAE, Janssen L, Lagerwaard B, Nuijten MAH, Bongers CCWG, Rodenburg RJ, Thompson PD, Eijsvogels TMH, Assendelft WJJ, Schirris TJJ, Timmers S, Hopman MTE. Prolonged Moderate-Intensity Exercise Does Not Increase Muscle Injury Markers in Symptomatic or Asymptomatic Statin Users. J Am Coll Cardiol. 2023 Apr 11;81(14):1353-1364. doi: 10.1016/j.jacc.2023.01.043.
- 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 6 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 27 Aug 2021. 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?
Muscle damage markers (time frame: Baseline (before exercise) and after three days of moderate-intensity walking exercise (measured each day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011643, which also lists 1 linked publication.
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 27 Aug 2021.