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

Not Applicable

Completed

• Conditions: Heart Diseases
• Interventions: Other: Exercise training

• Registration Number: NCT04195932
• Lead Sponsor: East Tennessee State University

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).

Detailed 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

Study Timeline

• Study Start: 1996-12
• Primary Completion: 1998-05
• Study Completion: 1998-05
• Status Verified: 2019-12
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

• abnormal EKG
• abnormal stress test
• presence of a chronic inflammatory disease
• presence of malignancy
• immunosuppressive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise training	6 moths of supervised moderate intensity aerobic and resistive exercise training

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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+).

Trial Locations

Locations (1)

James H. Quillen College of Medicine; 🇺🇸 Johnson City, Tennessee, United States