Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

May 6, 2016 updated by: John Kelly Smith, East Tennessee State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Johnson City, Tennessee, United States, 70571
        • James H. Quillen College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal exercise treadmill test

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

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)
Time Frame: 6 months
6 months
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
6 months
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
6 months
Evidence of altered blood mononuclear cell phenotypes
Time Frame: 6 months
Immunophenotyping of blood mononuclear cells by FACScan flow cytometer
6 months
Evidence of altered serum factors of bone homeostasis
Time Frame: 6 months
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
Time Frame: 6 months
Measurements of IL-2, IL-4, IL-12
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Tennessee State University

Investigators

  • Principal Investigator: John K Smith, MD, James H. Quillen College of Medicine, Johnson City, Tennesse, United States 70571

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Primary Completion (Actual)

April 1, 1998

Study Completion (Actual)

April 1, 1998

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Estimate)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-028f

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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