Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

Not Applicable

Completed

• Conditions: Osteoporosis

• Registration Number: NCT02765945
• Lead Sponsor: East Tennessee State University

Brief Summary

This is the second phase of a study designed to determine the immunological effects of long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis (phase 2). The results indicate that six months of moderate intensity exercise reduces bone resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral blood mononuclear cells.

Detailed Description

In a before and after trial involving 43 healthy adults the investigators measured the effect of six months of supervised exercise on the spontaneous and phytohemagglutinin-induced production of osteoclastogenic cytokines (interleukin-1α, tumor necrosis factor-α), anti-osteoclastogenic cytokines (transforming growth factor-β, interleukins 4 and10), pleiotropic cytokines with variable effects on osteoclastogenesis (interferon-γ, interleukin-6), and T cell growth and differentiation factors (interleukins 2 and 12) by peripheral blood mononuclear cells. The investigators also measured lymphocyte phenotypes, and serum markers of bone formation (osteocalcin), bone resorption (C-terminal telopeptides of Type I collagen), and bone homeostasis (estradiol, vitamin D2, testosterone, parathyroid hormone, insulin-like growth factor).

Study Timeline

• Study Start: 1996-12
• Primary Completion: 1998-04
• Study Completion: 1998-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-06
• Last Update Submitted: 2016-05-06
• Study First Posted: 2016-05-09
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Normal exercise treadmill test

Exclusion Criteria

• Any medical condition that would prevent participation in a six month exercise program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evidence of altered bone resorption and/or production as measured by measurements of serum levels of osteocalcin and degradation products of Type I collagen (C-terminal telopeptides)	6 months
Evidence of altered secretion of osteoclastogenic cytokines by peripheral blood mononuclear cells	6 months	secretion of IL-1 alpha, TNF-alpha, IFN-gamma by cultured peripheral blood mononuclear cells
Evidence of altered secretion of anti-osteoclastogenic cytokines by cultured peripheral blood mononuclear cells	6 months	secretion of IL-10, IL-4, TGF-beta, IL-6 by cultured peripheral blood mononuclear cells
Evidence of altered blood mononuclear cell phenotypes	6 months	Immunophenotyping of blood mononuclear cells by FACScan flow cytometer
Evidence of altered serum factors of bone homeostasis	6 months	Measurements of serum levels of estradiol, testosterone, PTH, IGF-1
Evidence of altered secretion of growth and differentiation factors by cultures peripheral blood mononuclear cells	6 months	Measurements of IL-2, IL-4, IL-12

Trial Locations

Locations (1)

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