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Exercise and Inflammation

Not Applicable
Completed
Conditions
Cardiovascular Disease
Interventions
Behavioral: aerobic training
Behavioral: Wait list
Registration Number
NCT01335737
Lead Sponsor
New York State Psychiatric Institute
Brief Summary

The purpose of this study is to test the hypothesis that aerobic exercise leads to attenuation of the inflammatory response to lipopolysaccharide (LPS) stimulation.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
241
Inclusion Criteria
  1. Age 20-45 years old
  2. English-speaking
  3. Ambulatory
  4. BMI < 32
  5. Pre-menopausal (women only) with regular cycle lengths between 26-32 days
  6. "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
  1. Use of anti-psychotic medications
  2. Current of past major depressive disorder, or total symptom score > 10
  3. BMI<18
  4. Heart disease
  5. Hypertension
  6. Diabetes mellitus
  7. Neurologic disease
  8. Smoking
  9. 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.
  10. Use of any medication with autonomic effects
  11. Use of birth control medication
  12. Ischemic changes, abnormal blood pressure responses, significant ectopy
  13. Appears to be at high risk to be unable to adhere to study protocol

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
aerobic trainingaerobic training12 weeks of aerobic training, 4 times/week
wait list controlWait listwait list control condition, 12 weeks + 4 to parallel the deconditioning protocol in active intervention group
Primary Outcome Measures
NameTimeMethod
tumor necrosis factor (TNF-alpha)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

Secondary Outcome Measures
NameTimeMethod
cerebral blood volume (CBV) in the dentate gyruschange from before (pre) to after (post) 12 weeks of training
Change in mood, including depressive symptomatology and negative affectchange 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-10change 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

TLR-4change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning

TLR-4 will be measured from blood samples

Trial Locations

Locations (1)

Columbia University Medical Center

🇺🇸

New York, New York, United States

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