Exercise as an Modulator of Immunological Risk Factors for Osteoporosis
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised exercise program
Sponsored by
About this trial
This is an interventional basic science trial for Osteoporosis focused on measuring Exercise, Osteoporosis, Cytokines
Eligibility Criteria
Inclusion Criteria:
- Normal exercise treadmill test
Exclusion Criteria:
- Any medical condition that would prevent participation in a six month exercise program
Sites / Locations
- James H. Quillen College of Medicine
Outcomes
Primary Outcome Measures
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)
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
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
Evidence of altered blood mononuclear cell phenotypes
Immunophenotyping of blood mononuclear cells by FACScan flow cytometer
Evidence of altered serum factors of bone homeostasis
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
Measurements of IL-2, IL-4, IL-12
Secondary Outcome Measures
Full Information
NCT ID
NCT02765945
First Posted
May 5, 2016
Last Updated
May 6, 2016
Sponsor
East Tennessee State University
1. Study Identification
Unique Protocol Identification Number
NCT02765945
Brief Title
Exercise as an Modulator of Immunological Risk Factors for Osteoporosis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
April 1998 (Actual)
Study Completion Date
April 1998 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tennessee State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Exercise, Osteoporosis, Cytokines
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Supervised exercise program
Intervention Description
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 Measure Information:
Title
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
Title
Evidence of altered secretion of osteoclastogenic cytokines by peripheral blood mononuclear cells
Description
secretion of IL-1 alpha, TNF-alpha, IFN-gamma by cultured peripheral blood mononuclear cells
Time Frame
6 months
Title
Evidence of altered secretion of anti-osteoclastogenic cytokines by cultured peripheral blood mononuclear cells
Description
secretion of IL-10, IL-4, TGF-beta, IL-6 by cultured peripheral blood mononuclear cells
Time Frame
6 months
Title
Evidence of altered blood mononuclear cell phenotypes
Description
Immunophenotyping of blood mononuclear cells by FACScan flow cytometer
Time Frame
6 months
Title
Evidence of altered serum factors of bone homeostasis
Description
Measurements of serum levels of estradiol, testosterone, PTH, IGF-1
Time Frame
6 months
Title
Evidence of altered secretion of growth and differentiation factors by cultures peripheral blood mononuclear cells
Description
Measurements of IL-2, IL-4, IL-12
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal exercise treadmill test
Exclusion Criteria:
Any medical condition that would prevent participation in a six month exercise program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K Smith, MD
Organizational Affiliation
James H. Quillen College of Medicine, Johnson City, Tennesse, United States 70571
Official's Role
Principal Investigator
Facility Information:
Facility Name
James H. Quillen College of Medicine
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
70571
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27642534
Citation
Smith JK, Dykes R, Chi DS. The Effect of Long-Term Exercise on the Production of Osteoclastogenic and Antiosteoclastogenic Cytokines by Peripheral Blood Mononuclear Cells and on Serum Markers of Bone Metabolism. J Osteoporos. 2016;2016:5925380. doi: 10.1155/2016/5925380. Epub 2016 Aug 24.
Results Reference
derived
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Exercise as an Modulator of Immunological Risk Factors for Osteoporosis
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