Exercise as an Modulator of Immunological Risk Factors for Osteoporosis

NCT02765945 | Completed

• 1 other identifier: 96-028f
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Exercise; Osteoporosis; Cytokines

Outcome Measures

Primary Outcomes (6)

• 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)

  6 months

• 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

  6 months

• 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

  6 months

• Evidence of altered blood mononuclear cell phenotypes

  Immunophenotyping of blood mononuclear cells by FACScan flow cytometer

  6 months

• Evidence of altered serum factors of bone homeostasis

  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

  Measurements of IL-2, IL-4, IL-12

  6 months

Interventions

Supervised exercise program OTHER

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

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal exercise treadmill test

You may not qualify if:

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

Sponsors & Collaborators

• East Tennessee State University: lead

Study Sites (1)

James H. Quillen College of Medicine

Johnson City, Tennessee, 70571, United States

Location

Related Publications (1)

• 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.

  PMID: 27642534 DERIVED

MeSH Terms

Conditions

Osteoporosis; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• John K Smith, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 9, 2016
• Study Start: December 1, 1996
• Primary Completion: April 1, 1998
• Study Completion: April 1, 1998
• Last Updated: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)