Completed

Statins and Exercise Effects on Health in Dyslipidaemia Patients

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What is being tested

Atorvastatin 80mg

+ Exercise

DrugBehavioral
Who is being recruted

Metabolic Diseases+1

+ Nutritional and Metabolic Diseases

+ Dyslipidemias

From 40 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorUniversity of the Faroe Islands
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding how both statin medications and regular exercise affect people with dyslipidaemia, a condition characterized by abnormal cholesterol levels. Dyslipidaemia can lead to serious heart and blood vessel problems, so managing cholesterol levels is crucial. Statins are commonly used to lower bad cholesterol and reduce heart risks. However, there are concerns that statins might lessen the positive effects of exercise on muscle health and overall fitness. This research is important because it aims to discover the best ways to combine medication and exercise for better health outcomes in individuals aged 40-65 with dyslipidaemia. Participants in this study will undergo a program that includes statin therapy, exercise training, or both, to examine their effects on fitness and muscle health. Researchers will use various scientific methods to analyze changes in muscle proteins and metabolic functions. This study will also explore how genetic differences might influence how each person responds to the treatments. By understanding these interactions, the research hopes to provide insights into personalized care plans, improving the balance between medication use and exercise for managing dyslipidaemia effectively.

Official TitleCombined Effects of Statins and Exercise on Physiological Health Markers and Quality of Life in Patients With Dyslipidaemia
NCT06841536
Principal SponsorUniversity of the Faroe Islands
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Metabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders

Criteria

2 inclusion criteria required to participate
Age: 40-65 years
LDL-C > 4.0 mmol/L.
9 exclusion criteria prevent from participating
A history of major depression or other severe psychiatric disorders.
Severe renal dysfunction (creatinine clearance <30 mL/min).
Active pregnancy or breast feeding.
Severe hepatic impairment.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Atorvastatin (80 mg) will be ingested once daily as oral tablets (80 mg/day). The starting dosage is 40 mg per day with a weekly increment of 40 mg reaching the maintenance dosage of 80 mg per day on week two. The titration protocol may be extended for participants with intolerable side-effects, and participants with intolerable side-effects at 80 mg may stay at a lower dosage (40 mg) Exercise: The exercise will be performed as supervised aerobic interval training sessions on cycling ergometers lasting \~45 min, four times weekly for 12 weeks. The exercise training will be conducted as a combination of high- and moderate-intensity interval training to ensure optimal adaptations of the primary outcomes.

Group II

Atorvastatin (80 mg) will be ingested once daily as oral tablets (80 mg/day). The starting dosage is 40 mg per day with a weekly increment of 40 mg reaching the maintenance dosage of 80 mg per day on week two. The titration protocol may be extended for participants with intolerable side-effects, and participants with intolerable side-effects at 80 mg may stay at a lower dosage (40 mg) non-exercise: Participants are instructed to maintain habitual activity levels at the same level as when the participant was enrolled in the study.

Group III

Placebo (CaCO3) will be ingested once daily as oral tablets (volume-matched to atorvastatin group). Exercise: The exercise will be performed as supervised aerobic interval training sessions on cycling ergometers lasting \~45 min, four times weekly for 12 weeks. The exercise training will be conducted as a combination of high- and moderate-intensity interval training to ensure optimal adaptations of the primary outcomes.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of the Faroe Islands

Tórshavn, Faroe IslandsOpen University of the Faroe Islands in Google Maps
CompletedOne Study Center