OsteoporosisNCT02765945
Exercise as an Modulator of Immunological Risk Factors for Osteoporosis
A study testing Supervised exercise program in people with Osteoporosis, run by East Tennessee State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Supervised exercise program
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1996to Apr 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal exercise treadmill test
Who cannot join
- Any medical condition that would prevent participation in a six month exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
James H. Quillen College of Medicine
Johnson City, Tennessee, 70571
About this study
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
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.
Read the 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).
- Conditions
- Osteoporosis
- Being tested
- Supervised exercise program
- Keywords
- Exercise, Osteoporosis, Cytokines
- Medical subject headings
- Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 6 months
Evidence of altered blood mononuclear cell phenotypes
Immunophenotyping of blood mononuclear cells by FACScan flow cytometer
Measured: 6 months
Evidence of altered serum factors of bone homeostasis
Measurements of serum levels of estradiol, testosterone, PTH, IGF-1
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startDec 1996
- Primary completionApr 1998
- Study completionApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kelly Smith, East Tennessee State University
- Investigators
- John K Smith, MD, Principal investigator, James H. Quillen College of Medicine, Johnson City, Tennesse, United States 70571
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765945
- Sponsor's protocol ID
- 96-028f
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27642534
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02765945
- Acronym / sponsor ID
- 96-028f
- Conditions
- Osteoporosis
- Keywords
- Exercise, Osteoporosis, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Study start
- Dec 1996
- Primary completion
- Apr 1998 (actual)
- Study completion
- Apr 1998 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal exercise treadmill test
Key exclusion criteria (1 listed)
- Any medical condition that would prevent participation in a six month exercise program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise programSubjects 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 | Other | – |
Primary outcome
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
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
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
Evidence of altered blood mononuclear cell phenotypes
Time frame: 6 months
Immunophenotyping of blood mononuclear cells by FACScan flow cytometer
Evidence of altered serum factors of bone homeostasis
Time frame: 6 months
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
Time frame: 6 months
Measurements of IL-2, IL-4, IL-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Derived from this study: PubMed 27642534Smith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John K Smith, MD principal investigator
James H. Quillen College of Medicine, Johnson City, Tennesse, United States 70571
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise program in people with Osteoporosis, run by East Tennessee State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.