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Exercise and Inflammation

Primary Purpose

Cardiovascular Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

aerobic training

Wait list

About this trial

This is an interventional basic science trial for Cardiovascular Disease

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 20-45 years old
English-speaking
Ambulatory
BMI < 32
Pre-menopausal (women only) with regular cycle lengths between 26-32 days
"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:

Use of anti-psychotic medications
Current of past major depressive disorder, or total symptom score > 10
BMI<18
Heart disease
Hypertension
Diabetes mellitus
Neurologic disease
Smoking
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.
Use of any medication with autonomic effects
Use of birth control medication
Ischemic changes, abnormal blood pressure responses, significant ectopy
Appears to be at high risk to be unable to adhere to study protocol

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

aerobic training

wait list control

Arm Description

12 weeks of aerobic training, 4 times/week

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

Outcomes

Primary Outcome Measures

tumor necrosis factor (TNF-alpha)

TNF-alpha will be measured from whole blood samples stimulated with lipopolysaccharide

Secondary Outcome Measures

Change in mood, including depressive symptomatology and negative affect

interleukin 1 (IL-1), IL-6, IL-8, IL-10

these cytokines will be measured from whole blood samples stimulated with lipopolysaccharide

TLR-4

TLR-4 will be measured from blood samples

cerebral blood volume (CBV) in the dentate gyrus

Full Information

NCT ID

NCT01335737

First Posted

July 14, 2010

Last Updated

June 7, 2018

Sponsor

New York State Psychiatric Institute

Collaborators

Feinstein Institute for Medical Research

1. Study Identification

Unique Protocol Identification Number

NCT01335737

Brief Title

Exercise and Inflammation

Official Title

Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

Feinstein Institute for Medical Research

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aerobic training

Arm Type

Experimental

Arm Description

12 weeks of aerobic training, 4 times/week

Arm Title

wait list control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

aerobic training

Other Intervention Name(s)

Training, aerobic

Intervention Description

12 weeks of aerobic training, 4 times/week

Intervention Type

Behavioral

Intervention Name(s)

Wait list

Other Intervention Name(s)

Condition, wait list control

Intervention Description

wait list control condition

Primary Outcome Measure Information:

Title

tumor necrosis factor (TNF-alpha)

Description

TNF-alpha will be measured from whole blood samples stimulated with lipopolysaccharide

Time Frame

change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning

Secondary Outcome Measure Information:

Title

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

Title

interleukin 1 (IL-1), IL-6, IL-8, IL-10

Description

these cytokines will be measured from whole blood samples stimulated with lipopolysaccharide

Time Frame

change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning

Title

TLR-4

Description

TLR-4 will be measured from blood samples

Time Frame

change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning

Title

cerebral blood volume (CBV) in the dentate gyrus

Time Frame

change from before (pre) to after (post) 12 weeks of training

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 20-45 years old English-speaking Ambulatory BMI < 32 Pre-menopausal (women only) with regular cycle lengths between 26-32 days "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: Use of anti-psychotic medications Current of past major depressive disorder, or total symptom score > 10 BMI<18 Heart disease Hypertension Diabetes mellitus Neurologic disease Smoking 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. Use of any medication with autonomic effects Use of birth control medication Ischemic changes, abnormal blood pressure responses, significant ectopy Appears to be at high risk to be unable to adhere to study protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard P Sloan, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17626836

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.

Results Reference

result

PubMed Identifier

33337592

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.

Results Reference

derived

PubMed Identifier

31916828

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.

Results Reference

derived

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Exercise and Inflammation

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