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Completed

NCT Number: NCT02765945

Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

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.

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Key information

Conditions

Osteoporosis Behavior Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James H. Quillen College of Medicine

Johnson City, Tennessee, 70571, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal exercise treadmill test

Exclusion criteria

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

Treatment and study plan

Supervised exercise program

Other

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

Primary outcomes

  1. 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)

    Time frame: 6 months

  2. Evidence of altered secretion of osteoclastogenic cytokines by peripheral blood mononuclear cells

    Time frame: 6 months

    secretion of IL-1 alpha, TNF-alpha, IFN-gamma by cultured peripheral blood mononuclear cells

  3. Evidence of altered secretion of anti-osteoclastogenic cytokines by cultured peripheral blood mononuclear cells

    Time frame: 6 months

    secretion of IL-10, IL-4, TGF-beta, IL-6 by cultured peripheral blood mononuclear cells

  4. Evidence of altered blood mononuclear cell phenotypes

    Time frame: 6 months

    Immunophenotyping of blood mononuclear cells by FACScan flow cytometer

  5. Evidence of altered serum factors of bone homeostasis

    Time frame: 6 months

    Measurements of serum levels of estradiol, testosterone, PTH, IGF-1

  6. Evidence of altered secretion of growth and differentiation factors by cultures peripheral blood mononuclear cells

    Time frame: 6 months

    Measurements of IL-2, IL-4, IL-12

Sponsors and collaborators

Lead sponsor

East Tennessee State University

Other

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
1998
Study completion
1998
First posted
May 9, 2016
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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