Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine whether the effects of rosuvastatin treatment and exercise training can be synergistic, with respect to the innate immune receptor TLR4, markers of systemic inflammation, and stimulated production of inflammatory cytokines, in hypercholesterolemic subjects. It is hypothesized that a rosuvastatin and exercise intervention will synergistically lower measured variables, so as to be anti-inflammatory.


Clinical Trial Description

Both statin drugs and exercise training are known to exert anti-inflammatory effects. We found that both high levels of physical activity and an exercise training program reduced markers of inflammation and lowered monocyte Toll-like receptor 4 (TLR4) expression. It has not been determined whether statins exert their anti-inflammatory effects through the toll-like receptors or whether combined statin/exercise treatment will exert synergistic anti-inflammatory effects. Thus, the primary purposes of this study are two-fold: 1) Determine whether rosuvastatin treatment downregulates LPS-induced inflammatory responses, serum hsCRP, and monocyte TLR4 expression in hypercholesterolemic patients; and 2) Determine whether adding exercise training to rosuvastatin treatment induces an anti-inflammatory synergy and further lowers LPS-induced inflammatory response, hsCRP, and TLR4 expression. Thirty two hypercholesterolemic (total cholesterol > 200 mg/dL, LDL > 130 mg/dL) will be randomly divided into two groups: statin (ST) and statin and exercise (ST+E). Sixteen physically active, no-statin subjects will also be recruited as a control group(CON). After baseline blood sampling, ST and ST+E groups will begin a 10-week course of rosuvastatin calcium treatment (10 mg/d) after which a second blood sample will be obtained. The ST+E group will then begin a 10 week (three days per week) combined endurance (20 min at 70% of heart rate reserve) and resistive training (2 sets of 10 upper- and lower-body exercises) program. The ST group will not exercise and both ST+E and ST groups will continue taking their medication, as prescribed. A final blood sample will be taken at the end of this 10-week segment. Blood samples will also be taken from the CON group at 0, 10 and 20 weeks. Monocyte expression of TLR4, CD14 (LPS receptor) and CD16 (monocyte maturation marker) will be assessed using flow cytometry. LPS-stimulated inflammatory cytokine production and serum levels of hsCRP, TNF-a, oxLDL, LDL, HDL, endotoxin, LPS binding protein, and sCD14 will also be measured at each time point (baseline, 10 weeks, 20 weeks). These experiments will allow us to determine whether rosuvastatin downregulates TLR4, an important mediator of inflammation, and whether exercise, known to lower TLR4 expression, can augment the rosuvastatin effects. Regular exercise and statin treatment are known to reduce disease risk, but the benefits of these treatments is infrequently attributed to their anti-inflammatory effects. It is important to document mechanisms of anti-inflammatory action for exercise training and statin treatment and to determining whether these treatments have combined beneficial effects. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00295373
Study type Interventional
Source Purdue University
Contact
Status Active, not recruiting
Phase Phase 4
Start date February 2006
Completion date August 2007

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT05294692 - Using Behavioural Economics for More Sustainable Physical Activity mHealth Incentives: the Caterpillar App N/A
Recruiting NCT05619250 - Supervised Center-based vs. Unsupervised Home-based Exercise Programs (PRO-Training) N/A
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Not yet recruiting NCT05963893 - Promoting a Healthy Life Through Gender Equity
Enrolling by invitation NCT05461989 - Physical Activity Barriers in Adolescent Hypertension Patients
Completed NCT06063187 - Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Active, not recruiting NCT06089876 - The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement N/A
Recruiting NCT05608707 - APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults. N/A
Enrolling by invitation NCT06033417 - Walking and Blood Pressure in Older Adults With Respiratory Impairment. N/A
Not yet recruiting NCT05887583 - Supporting Physical Literacy at School and Home N/A
Completed NCT05535400 - Effects of Physical-Psychological Integrative Intervention on SCI Patient: a Pilot Randomized Controlled Trial N/A
Recruiting NCT06095999 - Perfect Fit: Evaluation of a Virtual Coach for Smoking Cessation and Physical Activity N/A
Completed NCT06246812 - Text Message and Competition-Based Interventions Among University Students N/A
Recruiting NCT05935982 - Virtual Reality Exercise in a Community Highschool for Children With Disabilities Phase 1
Not yet recruiting NCT06027502 - Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept N/A
Recruiting NCT05147909 - Impact of Dietary Phosphate Excess on Exercise Capacity and Visceral Adiposity N/A
Recruiting NCT06185413 - Children's Cooperation Denmark: a 3-year System Dynamics Trial N/A
Completed NCT06018974 - Digital Gaming Intervention for Older People in Long-term Care N/A
Recruiting NCT05425641 - MoST-Influenced Behavioral Intervention for Walking Phase 2