Clinical trial NCT01335737: Exercise and Inflammation
Official title: Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Feinstein Institute for Medical Research
First posted: 2011-04-14
Enrollment: 241
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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 criteria: 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

Primary outcomes:
measure: tumor necrosis factor (TNF-alpha)
timeFrame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
Secondary outcomes:
measure: Change in mood, including depressive symptomatology and negative affect
timeFrame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
measure: interleukin 1 (IL-1), IL-6, IL-8, IL-10
timeFrame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
measure: TLR-4
timeFrame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning
measure: cerebral blood volume (CBV) in the dentate gyrus
timeFrame: change from before (pre) to after (post) 12 weeks of training
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Richard P Sloan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1152/japplphysiol.00147.2007. Epub 2007 Jul 12.
citation: Sloan RP, Shapiro PA, Lauriola V, McIntyre K, Pavlicova M, Choi CJ, Choo TH, Scodes JM. The Impact of Aerobic Training on Cardiovascular Reactivity to and Recovery From Psychological and Orthostatic Challenge. Psychosom Med. 2021 Feb-Mar 01;83(2):125-137. doi: 10.1097/PSY.0000000000000896.
citation: McIntyre KM, Puterman E, Scodes JM, Choo TH, Choi CJ, Pavlicova M, Sloan RP. The effects of aerobic training on subclinical negative affect: A randomized controlled trial. Health Psychol. 2020 Apr;39(4):255-264. doi: 10.1037/hea0000836. Epub 2020 Jan 9.