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

Sponsor

East Tennessee State University (Other)

Overall Status

Completed

CT.gov ID

NCT04195932

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases	Other: Exercise training	N/A

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Before and after studyBefore and after study

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 1, 1996

Actual Primary Completion Date :

May 1, 1998

Actual Study Completion Date :

May 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise 6 moths of supervised moderate intensity aerobic and resistive exercise training	Other: Exercise training

Arm

Intervention/Treatment

Experimental: Exercise

6 moths of supervised moderate intensity aerobic and resistive exercise training

Other: Exercise training

Outcome Measures

Primary Outcome Measures

Effect of exercise on atherogenic cytokine production by mitogen-stimulated peripheral blood mononuclear cells [1 year]
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)-1α, tumor necrosis factor (TNF)-α, and interferon (IFN)-γ using solid phase enzyme linked immunoassay kits.
Effect of exercise on plasma lipids and oxidizable low density lipoprotein cholesterol levels [1 year]
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.

Secondary Outcome Measures

Effect of exercise on blood lymphocyte phenotypes [1 year]
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+).