search
Back to results

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

Primary Purpose

Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
East Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Diseases focused on measuring exercise, hyperlipidemia, TNF-alpha, atherogenesis, LDL-cholesterol, oxidized LDL-C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • James H. Quillen College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

6 moths of supervised moderate intensity aerobic and resistive exercise training

Outcomes

Primary Outcome Measures

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)-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
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
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+).

Full Information

First Posted
December 6, 2019
Last Updated
December 10, 2019
Sponsor
East Tennessee State University
search

1. Study Identification

Unique Protocol Identification Number
NCT04195932
Brief Title
Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease
Official Title
Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 1996 (Actual)
Primary Completion Date
May 1998 (Actual)
Study Completion Date
May 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tennessee State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
exercise, hyperlipidemia, TNF-alpha, atherogenesis, LDL-cholesterol, oxidized LDL-C

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after study
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
6 moths of supervised moderate intensity aerobic and resistive exercise training
Intervention Type
Other
Intervention Name(s)
Exercise training
Primary Outcome Measure Information:
Title
Effect of exercise on atherogenic cytokine production by mitogen-stimulated peripheral blood mononuclear cells
Description
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.
Time Frame
1 year
Title
Effect of exercise on plasma lipids and oxidizable low density lipoprotein cholesterol levels
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effect of exercise on blood lymphocyte phenotypes
Description
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+).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K Smith, MD
Organizational Affiliation
East Tennessee State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
James H. Quillen College of Medicine
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
70571
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs