Exercise and Inflammation

This study is currently recruiting participants.
Verified February 2013 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Feinstein Institute for Medical Research
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01335737
First received: July 14, 2010
Last updated: October 22, 2013
Last verified: February 2013

July 14, 2010
October 22, 2013
January 2010
December 2015   (final data collection date for primary outcome measure)
tumor necrosis factor (TNF-alpha) [ Time Frame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning ] [ Designated as safety issue: No ]
TNF-alpha will be measured from whole blood samples stimulated with lipopolysaccharide
Same as current
Complete list of historical versions of study NCT01335737 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    these cytokines will be measured from whole blood samples stimulated with lipopolysaccharide
  • TLR-4 [ Time Frame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning ] [ Designated as safety issue: No ]
    TLR-4 will be measured from blood samples
  • cerebral blood volume (CBV) in the dentate gyrus [ Time Frame: change from before (pre) to after (post) 12 weeks of training ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise and Inflammation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Cardiovascular Disease
  • Behavioral: aerobic training
    12 weeks of aerobic training, 4X/week
    Other Name: Training, aerobic
  • Behavioral: Wait list
    wait list control condition
    Other Name: Condition, wait list control
  • Experimental: aerobic training
    12 weeks of aerobic training, 4X/week
    Intervention: Behavioral: aerobic training
  • Placebo Comparator: wait list control
    wait list control condition, 12 weeks + 4 to parallel the deconditioning protocol in active intervention group
    Intervention: Behavioral: Wait list
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. 2007 Sep;103(3):1007-11. Epub 2007 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
182
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 20-45 years old
  2. English-speaking
  3. Ambulatory Interview
  4. BMI < 32
  5. Pre-menopausal (women only) with regular cycle lengths between 26-32 days
  6. "Average" fitness as determined by AHA standards (VO2max < 43 ml/kg/min for men, < 37 ml/kg/min for women) VO2max test

Exclusion Criteria:

  1. Use of psychotropic medications
  2. Past or current psychiatric disorder
  3. Heart disease
  4. Hypertension
  5. Diabetes mellitus
  6. Neurologic disease
  7. Smoking
  8. Any condition for which aerobic training is counterindicated
  9. Use of any medication with autonomic effects
  10. Use of birth control medication
  11. Ischemic changes, abnormal blood pressure responses, significant ectopy
Both
20 Years to 45 Years
Yes
Not Provided
United States
 
NCT01335737
5948, HL094423
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
Feinstein Institute for Medical Research
Principal Investigator: Richard P Sloan, PhD Columbia University
New York State Psychiatric Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP