Exercise and Inflammation

June 7, 2018 updated by: Richard Sloan, New York State Psychiatric Institute

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aerobic training
12 weeks of aerobic training, 4 times/week
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
wait list control condition
Other Names:
  • Condition, wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
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
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
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
change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
cerebral blood volume (CBV) in the dentate gyrus
Time Frame: change from before (pre) to after (post) 12 weeks of training
change from before (pre) to after (post) 12 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 5948/6956R
  • HL094423 (Other Identifier: CU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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