Exercise and Inflammation

NCT ID: NCT01335737

Last Updated: 2018-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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aerobic training

12 weeks of aerobic training, 4 times/week

Group Type EXPERIMENTAL

aerobic training

Intervention Type BEHAVIORAL

12 weeks of aerobic training, 4 times/week

wait list control

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

Group Type PLACEBO_COMPARATOR

Wait list

Intervention Type BEHAVIORAL

wait list control condition

Interventions

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aerobic training

12 weeks of aerobic training, 4 times/week

Intervention Type BEHAVIORAL

Wait list

wait list control condition

Intervention Type BEHAVIORAL

Other Intervention Names

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Training, aerobic Condition, wait list control

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Feinstein Institute for Medical Research

OTHER

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Richard Sloan

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard P Sloan, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17626836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33337592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31916828 (View on PubMed)

Other Identifiers

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HL094423

Identifier Type: OTHER

Identifier Source: secondary_id

5948/6956R

Identifier Type: -

Identifier Source: org_study_id

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