Clinical trial NCT02765945: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Exercise
Osteoporosis
Cytokines
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 43
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: Inclusion Criteria:

* Normal exercise treadmill test

Exclusion Criteria:

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

Primary outcomes:
measure: 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)
timeFrame: 6 months
measure: Evidence of altered secretion of osteoclastogenic cytokines by peripheral blood mononuclear cells
timeFrame: 6 months
measure: Evidence of altered secretion of anti-osteoclastogenic cytokines by cultured peripheral blood mononuclear cells
timeFrame: 6 months
measure: Evidence of altered blood mononuclear cell phenotypes
timeFrame: 6 months
measure: Evidence of altered serum factors of bone homeostasis
timeFrame: 6 months
measure: Evidence of altered secretion of growth and differentiation factors by cultures peripheral blood mononuclear cells
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: James H. Quillen College of Medicine
state: Tennessee
Study officials:
affiliation: James H. Quillen College of Medicine, Johnson City, Tennesse, United States 70571
name: John K Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.