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Exercise and Inflammation

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01335737
Collaborator
Feinstein Institute for Medical Research (Other)
241
Enrollment
1
Location
2
Arms
62.9
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: aerobic training
  • Behavioral: Wait list
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
241 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: aerobic training

12 weeks of aerobic training, 4 times/week

Behavioral: aerobic training
12 weeks of aerobic training, 4 times/week
Other Names:
  • Training, aerobic

    		•
    Placebo Comparator: wait list control

    wait list control condition, 12 weeks + 4 to parallel the deconditioning protocol in active intervention group

    Behavioral: Wait list
    wait list control condition
    Other Names:
  • Condition, wait list control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change in mood, including depressive symptomatology and negative affect [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 [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 [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 [change from before (pre) to after (post) 12 weeks of training]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • New York State Psychiatric Institute
    • Feinstein Institute for Medical Research

    Investigators

    • Principal Investigator: Richard P Sloan, PhD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard Sloan, Research Scientist, New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT01335737
    Other Study ID Numbers:
    • 5948/6956R
    • HL094423
    First Posted:
    Apr 14, 2011
    Last Update Posted:
    Jun 11, 2018
    Last Verified:
    Jun 1, 2018
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Inflammation

    Study Results

    No Results Posted as of Jun 11, 2018