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Completed

NCT Number: NCT01335737

Exercise and Inflammation

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

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic training

Behavioral

12 weeks of aerobic training, 4 times/week

Other names: Training, aerobic

Wait list

Behavioral

wait list control condition

Other names: Condition, wait list control

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. cerebral blood volume (CBV) in the dentate gyrus

    Time frame: change from before (pre) to after (post) 12 weeks of training

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Feinstein Institute for Medical Research

Registry information

Official study title

Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2011
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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