Exercise and Inflammation

Cardiovascular Disease Clinical Trial

Official title:

Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335737
• Other study ID #: 5948/6956R
• Secondary ID: HL094423
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: April 2015

Study information

• Verified date: June 2018
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Inflammation

Intervention

Behavioral:
• aerobic training
12 weeks of aerobic training, 4 times/week
• Wait list
wait list control condition

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Feinstein Institute for Medical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 (1985). 2007 Sep;103(3):1007-11. Epub 2007 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor necrosis factor (TNF-alpha)	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	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
Secondary	interleukin 1 (IL-1), IL-6, IL-8, IL-10	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
Secondary	TLR-4	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
Secondary	cerebral blood volume (CBV) in the dentate gyrus		change from before (pre) to after (post) 12 weeks of training