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

NCT04195932 | Completed

• 1 other identifier: ETSU2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Diseases

Keywords

exercise; hyperlipidemia; TNF-alpha; atherogenesis; LDL-cholesterol; oxidized LDL-C

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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 Outcomes (1)

• Effect of exercise on blood lymphocyte phenotypes

  1 year

Study Arms (1)

Exercise

EXPERIMENTAL

6 moths of supervised moderate intensity aerobic and resistive exercise training

Other: Exercise training

Interventions

Exercise training OTHER

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normal EKG
• normal stress test

You may not qualify if:

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

Sponsors & Collaborators

• East Tennessee State University: lead

Study Sites (1)

James H. Quillen College of Medicine

Johnson City, Tennessee, 70571, United States

Location

MeSH Terms

Conditions

Heart Diseases; Motor Activity; Hyperlipidemias; Atherosclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Behavior; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John K Smith, MD

  East Tennessee State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Medicine

Model Details: Before and after study

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 12, 2019
• Study Start: December 1, 1996
• Primary Completion: May 1, 1998
• Study Completion: May 1, 1998
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)