Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

NCT ID: NCT02765945

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Study Completion Date

1998-04-30

Brief Summary

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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

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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).

Conditions

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Normal exercise treadmill test

Exclusion Criteria

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

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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East Tennessee State University

OTHER

Sponsor Role lead

Responsible Party

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John Kelly Smith

Emeritus Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John K Smith, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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James H. Quillen College of Medicine

Johnson City, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27642534 (View on PubMed)

Other Identifiers

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96-028f

Identifier Type: -

Identifier Source: org_study_id

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