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
  Purpose

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 Intervention
Cardiovascular Disease
Behavioral: aerobic training
Behavioral: Wait list

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 182
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aerobic training
12 weeks of aerobic training, 4 times/week
Behavioral: aerobic training
12 weeks of aerobic training, 4 times/week
Other Name: 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 Name: Condition, wait list control

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335737

Contacts
Contact: Amberle Cusmano 6467748952 cusmano@nyspi.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Amberle Cusmano    646-774-8952    cusmano@nyspi.columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
Feinstein Institute for Medical Research
Investigators
Principal Investigator: Richard P Sloan, PhD Columbia University
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01335737     History of Changes
Other Study ID Numbers: 5948/6956R, HL094423
Study First Received: July 14, 2010
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014