- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01335737
Exercise and Inflammation
June 7, 2018 updated by: Richard Sloan, New York State Psychiatric Institute
Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms
The purpose of this study is to test the hypothesis that aerobic exercise leads to attenuation of the inflammatory response to lipopolysaccharide (LPS) stimulation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Aerobic exercise - the most widely recommended health behavior - is recognized to reduce the risk of coronary heart disease, so much so that consensus panels routinely include it as part of a cardioprotective regimen for healthy people, but the physiological or mechanistic basis of this protection is uncertain.
Understanding the mechanisms has considerable public health significance because it will allow development and testing of targeted interventions to produce comparable cardioprotective effects more directly or in cases where aerobic exercise is not possible.
This application proposes to test the hypothesis that aerobic training leads to attenuation of the inflammatory response to LPS stimulation and to examine the role played by exercise-induced increases in vagal activity, improvements in mood, and decreased expression of Toll Receptor 4 (TLR4), the cognate receptor for endotoxin expressed by monocytes.
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 20-45 years old
- English-speaking
- Ambulatory
- BMI < 32
- Pre-menopausal (women only) with regular cycle lengths between 26-32 days
- "Average" fitness as determined by American Heart Association standards (VO2max < 43 ml/kg/min for men, < 37 ml/kg/min for women) VO2max test
Exclusion Criteria:
- Use of anti-psychotic medications
- Current of past major depressive disorder, or total symptom score > 10
- BMI<18
- Heart disease
- Hypertension
- Diabetes mellitus
- Neurologic disease
- Smoking
- Individuals with ischemic heart disease, cardiac arrhythmias, peripheral vascular disease, orthopedic problems such as foot, leg, hip and spine problems,movement disorders, other neurological disorders affecting gait or balance, conditions or treatments associated with impaired thermoregulation, or other medical problems, for which aerobic training would be contraindicated.
- Use of any medication with autonomic effects
- Use of birth control medication
- Ischemic changes, abnormal blood pressure responses, significant ectopy
- Appears to be at high risk to be unable to adhere to study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: aerobic training
12 weeks of aerobic training, 4 times/week
|
12 weeks of aerobic training, 4 times/week
Other Names:
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Placebo Comparator: wait list control
wait list control condition, 12 weeks + 4 to parallel the deconditioning protocol in active intervention group
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wait list control condition
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tumor necrosis factor (TNF-alpha)
Time Frame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
TNF-alpha will be measured from whole blood samples stimulated with lipopolysaccharide
|
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mood, including depressive symptomatology and negative affect
Time Frame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
|
|
interleukin 1 (IL-1), IL-6, IL-8, IL-10
Time Frame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
these cytokines will be measured from whole blood samples stimulated with lipopolysaccharide
|
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
|
TLR-4
Time Frame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
TLR-4 will be measured from blood samples
|
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
|
|
cerebral blood volume (CBV) in the dentate gyrus
Time Frame: change from before (pre) to after (post) 12 weeks of training
|
change from before (pre) to after (post) 12 weeks of training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sloan RP, Shapiro PA, Demeersman RE, McKinley PS, Tracey KJ, Slavov I, Fang Y, Flood PD. Aerobic exercise attenuates inducible TNF production in humans. J Appl Physiol (1985). 2007 Sep;103(3):1007-11. doi: 10.1152/japplphysiol.00147.2007. Epub 2007 Jul 12.
- Sloan RP, Shapiro PA, Lauriola V, McIntyre K, Pavlicova M, Choi CJ, Choo TH, Scodes JM. The Impact of Aerobic Training on Cardiovascular Reactivity to and Recovery From Psychological and Orthostatic Challenge. Psychosom Med. 2021 Feb-Mar 01;83(2):125-137. doi: 10.1097/PSY.0000000000000896.
- McIntyre KM, Puterman E, Scodes JM, Choo TH, Choi CJ, Pavlicova M, Sloan RP. The effects of aerobic training on subclinical negative affect: A randomized controlled trial. Health Psychol. 2020 Apr;39(4):255-264. doi: 10.1037/hea0000836. Epub 2020 Jan 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
July 14, 2010
First Submitted That Met QC Criteria
April 13, 2011
First Posted (Estimate)
April 14, 2011
Study Record Updates
Last Update Posted (Actual)
June 11, 2018
Last Update Submitted That Met QC Criteria
June 7, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5948/6956R
- HL094423 (Other Identifier: CU)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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