Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise and Inflammation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 10, 2014
Last verified: September 2014

July 14, 2010
September 10, 2014
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, 4 times/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, 4 times/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 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
Both
20 Years to 45 Years
Yes
Contact: Amberle Cusmano 6467748952 cusmano@nyspi.columbia.edu
United States
 
NCT01335737
5948/6956R, 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
September 2014

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