Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02765945
Recruitment Status : Completed
First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
John Kelly Smith, 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Other: Supervised exercise program Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : December 1996
Actual Primary Completion Date : April 1998
Actual Study Completion Date : April 1998

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal exercise treadmill test

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765945


Locations
Layout table for location information
United States, Tennessee
James H. Quillen College of Medicine
Johnson City, Tennessee, United States, 70571
Sponsors and Collaborators
East Tennessee State University
Investigators
Layout table for investigator information
Principal Investigator: John K Smith, MD James H. Quillen College of Medicine, Johnson City, Tennesse, United States 70571

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: John Kelly Smith, Emeritus Professor of Medicine, East Tennessee State University
ClinicalTrials.gov Identifier: NCT02765945     History of Changes
Other Study ID Numbers: 96-028f
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Kelly Smith, East Tennessee State University:
Exercise
Osteoporosis
Cytokines

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases