Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of Long-term Exercise on the Production of Osteoclastogenic and Anti-osteoclastogenic Cytokines by Peripheral Blood Mononuclear Cells and on Serum Markers of Bone Metabolism

Conditions
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Osteoporosis

Intervention / Treatment
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* Other: Supervised exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal exercise treadmill test Exclusion Criteria: Any medical condition that would prevent participation in a six month exercise program

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Supervised exercise program|Subjects were enrolled in a hospital-based wellness center where, after analysis of their medical history and previous levels of physical activity ands documentation of a normal exercise stress test, they chose individually tailored exercise programs|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | secretion of IL-1 alpha, TNF-alpha, IFN-gamma by cultured peripheral blood mononuclear cells | 6 months | 
| Evidence of altered secretion of anti-osteoclastogenic cytokines by cultured peripheral blood mononuclear cells | secretion of IL-10, IL-4, TGF-beta, IL-6 by cultured peripheral blood mononuclear cells | 6 months | 
| Evidence of altered blood mononuclear cell phenotypes | Immunophenotyping of blood mononuclear cells by FACScan flow cytometer | 6 months | 
| Evidence of altered serum factors of bone homeostasis | Measurements of serum levels of estradiol, testosterone, PTH, IGF-1 | 6 months | 
| Evidence of altered secretion of growth and differentiation factors by cultures peripheral blood mononuclear cells | Measurements of IL-2, IL-4, IL-12 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Osteoporosis, Cytokines