Combining exercise training and statins to improve heart health
The Effects of Supervised Exercise Training in the Primary Prevention of Cardiovascular Disease in Stain-Users and Non Statin-Users
This study is testing whether combining moderate exercise with statin medication can help improve heart health in people aged 50-65 who are at risk for heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | Cardiff Metropolitan University Academic / other |
| Locations | 1 site (Cardiff) |
| Trial ID | NCT05474079 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined effects of moderate intensity exercise training and statin therapy on cardiovascular health in individuals at risk for cardiovascular disease (CVD). Participants aged 50-65 with a 10-year CVD-risk score greater than 10% will be recruited, including both statin users and non-users. The study aims to assess how these interventions can improve vascular function and reduce the risk of CVD events. Sensitive ultrasound techniques will be employed to evaluate changes in cardiovascular structure and function throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates are sedentary, non-smoking adults aged 50-65 with a 10-year CVD-risk score greater than 10%.
Not a fit: Patients with established cardiovascular, metabolic, renal, or musculoskeletal diseases, or those with contraindications to exercise, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cardiovascular events in at-risk individuals.
How similar studies have performed: While the combination of exercise and statins has shown promise in secondary prevention, this study's focus on primary prevention is relatively novel and less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Statin Users: * Sedentary * Non-smokers * 50-65 years old * A 10-year CVD-risk score \> 10% (estimated via QRISK3) * Weight stable (\<5% weight change over the last 3 months) * Prescription of an 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA) inhibitor (statin) in stable dose for a minimum of 3 months and maximum of 3 years Non-Statin Users: * Sedentary * Non-smokers * 50-65 years old * A 10-year CVD-risk score \> 10% (estimated via QRISK3) * Weight stable (\<5% weight change over the last 3 months) Exclusion Criteria (Statin Users and Non-Statin Users): * History or signs/symptoms of established cardiovascular, metabolic, renal or musculoskeletal disease * Diagnosed with familial hyperlipidaemia and/or diabetes mellitus * Stage 2 hypertension (≥160/100 mmHg) * Any contraindications to exercise (e.g. unstable angina, severe orthopaedic conditions) and/or advised by GP not to undertake exercise * BMI \>40kg/m2 * Current smoker or within 6 months of cessation * Use of any medication other than statins (e.g., fibrates, metformin, thiazolidinediones, orlistat, anti-hypertensives) that could independently alter lipid metabolism and/or vascular function * Post-menopausal female and using hormone replacement therapy, or pre-menopausal using oral contraceptives that independently alter lipid metabolism and/or vascular function
Where this trial is running
Cardiff
- Cardiff Metropolitan University — Cardiff, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Chris Pugh — Cardiff Metropolitan University
- Study coordinator: Chris Pugh
- Email: cjpugh@cardiffmet.ac.uk
- Phone: 02920 205293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.