NCT03360916

Impact of Statin Therapy on Adaptations to Aerobic Exercise

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

Detailed description

High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. Statins may also change the ability to exercise. This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol. This study is expected to last about 14 weeks.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Lipitor 20Mg Tablet	One tablet by mouth every day for 12 weeks.
DRUG	Lipitor 80Mg Tablet	One tablet by mouth every day for 12 weeks.
DRUG	Placebo	One matching placebo tablet by mouth every day for 12 weeks.
BEHAVIORAL	Exercise Program	Exercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.

Timeline

• Start date: 2018-02-01
• Primary completion: 2024-06-05
• Completion: 2024-06-05
• First posted: 2017-12-04
• Last updated: 2025-04-15
• Results posted: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study