Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease

Heart Diseases Clinical Trial

Official title:

Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195932
• Other study ID #: ETSU2
• Status: Completed
• Phase: N/A
• Start date: December 1996
• Est. completion date: May 1998

Study information

• Verified date: December 2019
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A before and after study involving 43 adult subjects at risk of having ischemic heart disease. Subjects underwent 6 months of supervised moderate intensity aerobic and resistive exercise training. Blood samples were obtained at entry and at 6 months for measurement of complement (C3), CRP, blood lipid levels, lymphocyte phenotypes, and for the isolation, culture, and measurement of the spontaneous and phytohemagglutinin-induced secretion of proatherogenic and antiatherogenic cytokines by their peripheral blood mononuclear cells (PBMC).

Description:

A before and after study involving 43 adult subjects at risk of having ischemic heart disease. Subjects underwent 6 months of supervised moderate intensity aerobic and resistive exercise training. Blood samples were obtained at entry and at 6 months for measurement of complement (C3), CRP, blood lipid levels, lymphocyte phenotypes, and for the isolation, culture, and measurement of the spontaneous and phytohemagglutinin-induced secretion of proatherogenic and antiatherogenic cytokines by their peripheral blood mononuclear cells (PBMC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 1998
• Est. primary completion date: May 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• normal EKG

• normal stress test

Exclusion Criteria:

• abnormal EKG

• abnormal stress test

• presence of a chronic inflammatory disease

• presence of malignancy

• immunosuppressive therapy

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Exercise training

Locations

Country	Name	City	State
United States	James H. Quillen College of Medicine	Johnson City	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
East Tennessee State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of exercise on atherogenic cytokine production by mitogen-stimulated peripheral blood mononuclear cells	Pre- and post-exercise peripheral blood mononuclear cell (PBMC) preparations are isolated from venous blood, washed three times at 10 degrees C with sterile phosphate buffered saline (pH 7.4, 0.1 M) and suspended at a concentration of 2 million cells/uL in RPMI-1640. Preparations are incubated under 5% CO2 at 37 degrees C for 48 hours with phytohemagglutinin (5 ug/ml). Culture supernatants are rendered cell-free and supernatants assayed for Interleukin (IL)-1a, tumor necrosis factor (TNF)-a, and interferon (IFN)-? using solid phase enzyme linked immunoassay kits.	1 year
Primary	Effect of exercise on plasma lipids and oxidizable low density lipoprotein cholesterol levels	Pre- and post-exercise fasting plasma levels of total cholesterol (TC), very low density lipoprotein cholesterol (VLDL), low density lipoprotein cholesterol (LDL-C), and high density lipoprotein cholesterol (HDL-C) levels are measured using g-Max Quick-Seal tubes and potassium bromide (KBr) (d=1.006 g/mL). Tubes are centrifuged for 120 minutes at 68,000 rpm at 14 degrees C. The top layer (VLDL) is harvested, the bottom 3.7 mL adjusted to a density of 1.063 g/mL with KBr, and the tubes centrifuged for 150 minutes at 68,000 rpm at 14 degrees C to float the LDL-C. The bottom layer contains the HDL-C. TC, VLDL-C, LDL-C, and HDL concentrations are measured colorimetrically. LDL oxidizability is measured by oxidizing LDL-C (0.05 g/L) with 50 ug/mL Cu++ at 30 degrees C and measuring diene levels spectrometrically at 234 nm.	1 year
Secondary	Effect of exercise on blood lymphocyte phenotypes	Pre- and post-exercise blood samples are immunophenotyped using lysed whole blood, a FACScan flow cytometer, and fluorescein- and phycoerythrin-labeled murine monoclonal IgG antibodies to measure levels of T lymphocytes (CD3+), T helper lymphocytes (CD4+), T cytotoxic lymphocytes (CD8+), and T lymphocytes displaying MHC class II antigen (DR+), vascular adhesion molecule-4 (VLA-4) (CD49d+), lymphocyte function-associated antigen-1 (LFA-1) (CD11a+), Fas antigen (CD95+), and gamma-delta T cell receptors (TCR gamma-delta+). Also measured are B lymphocytes (CD3-CD19+), B1 lymphocytes (CD3-CD19+CD5+) and natural killer cells (NK cells) (CD3-CD16+CD56+).	1 year