Physical FitnessNCT00585403
Exercise Changes to Peripheral Blood Mononuclear Cells in Children
An observational study of Physical Fitness and Obesity, run by University of California, Irvine at 1 site in United States.
Trial summary
The goal of this research is to determine how the peripheral immune system is altered by exercise and differences related to gender, pubertal status and health. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Obesity, Child Development
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Dec 2004
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Early and late pubertal boys and girls recruited from Orange County, CA
Who may be able to join
- appropriate Tanner Stage
- No evidence of disease or disability
Who cannot join
- no use of antiinflammatory medications, alcohol, illegal drugs or bronchodilators
- elite children participating in extensive exercise or dance programs
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center
Orange, California, 92868
About this study
Official title: PBMC, Exercise and Children: Initial Mechanisms
The goal of this research is to determine how the peripheral immune system is altered by exercise and differences related to gender, pubertal status and health.
Read the detailed description
SPECIFIC AIMS:
- To systematically measure for the first time in healthy children and adolescents the effects of brief bouts of exercise on:
- Numbers of circulating PMBCs, their subsets and key intercellular adhesion molecules (ICAMs).
- PBMC gene regulation of stress, inflammatory, and growth/repair mediators [including: interleukin-4 (IL-4), IL-6, IL-10, tumor necrosis factor-alpha (TNF-alpha), interferon-gamma), growth hormone (GH), insulin-like growth factor-I (IGF-I), heat shock proteins (Hsp)].
- Circulating (serum) and intracellular PBMC levels of key mediators by flow cytometry and cell culture techniques.
- Circulating endogenous triggers of PBMC mediator responses-soluble Hsp, IL-6, and F2-isoprostanes.
- To determine how the acute PBMC responses are altered by gender, pubertal status, body composition (measured by whole-body and regional DEXA), and fitness (measured by progressive cycle ergometry and gas exchange).
- To determine the relationship in healthy children and adolescents among acute PBMC responses to exercise, biochemical precursors of the metabolic syndrome (insulin, glucose, lipids), and the balance of the TH1/TH2 immune response.
- Conditions
- Physical Fitness, Obesity, Child Development, Growth
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Early and late pubertal girls and boys |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionDec 2004
- Study completionDec 2004
Why it stopped: Nonapplicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan M Cooper, M.D., Principal investigator, Univ. California, Irvine, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585403
- Sponsor's protocol ID
- PBMC Exercise [2004-3967]
- Other IDs
- HL-80947
- Status last verified
- Jan 2021
- First submitted
- 26 Dec 2007
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PBMC, Exercise and Children: Initial Mechanisms
- ClinicalTrials.gov ID
- NCT00585403
- Acronym / sponsor ID
- PBMC Exercise [2004-3967]
- Conditions
- Physical Fitness, Obesity, Child Development, Growth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Nonapplicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 3 Jan 2008 (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.
The goal of this research is to determine how the peripheral immune system is altered by exercise and differences related to gender, pubertal status and health.
Detailed description
SPECIFIC AIMS:
- To systematically measure for the first time in healthy children and adolescents the effects of brief bouts of exercise on:
- Numbers of circulating PMBCs, their subsets and key intercellular adhesion molecules (ICAMs).
- PBMC gene regulation of stress, inflammatory, and growth/repair mediators [including: interleukin-4 (IL-4), IL-6, IL-10, tumor necrosis factor-alpha (TNF-alpha), interferon-gamma), growth hormone (GH), insulin-like growth factor-I (IGF-I), heat shock proteins (Hsp)].
- Circulating (serum) and intracellular PBMC levels of key mediators by flow cytometry and cell culture techniques.
- Circulating endogenous triggers of PBMC mediator responses-soluble Hsp, IL-6, and F2-isoprostanes.
- To determine how the acute PBMC responses are altered by gender, pubertal status, body composition (measured by whole-body and regional DEXA), and fitness (measured by progressive cycle ergometry and gas exchange).
- To determine the relationship in healthy children and adolescents among acute PBMC responses to exercise, biochemical precursors of the metabolic syndrome (insulin, glucose, lipids), and the balance of the TH1/TH2 immune response.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Early and late pubertal girls and boys |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Early and late pubertal boys and girls recruited from Orange County, CA
Key inclusion criteria (2 listed)
- appropriate Tanner Stage
- No evidence of disease or disability
Key exclusion criteria (3 listed)
- no use of antiinflammatory medications, alcohol, illegal drugs or bronchodilators
- elite children participating in extensive exercise or dance programs
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Related trials for Physical Fitness
Active, not recruitingObservational study
Respiratory Functions in Parkinson's Disease
Parkinson Disease
Not yet recruiting
Effects of the 11 for Health Program on Physical Fitness and Health-Related Outcomes in Schoolchildren
Physical Fitness, Health
Recruiting
The STRIVE Before Surgery Trial
Surgery-Complications, Disability Physical
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
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.
Dan M Cooper, M.D. principal investigator
Univ. California, Irvine, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Fitness and Obesity, run by University of California, Irvine 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Jan 2021. 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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 25 Jan 2021.