NCT01335737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

5.2 years

First QC Date

July 14, 2010

Last Update Submit

June 7, 2018

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

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

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

  • TLR-4

    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

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

Study Arms (2)

aerobic training

EXPERIMENTAL

12 weeks of aerobic training, 4 times/week

Behavioral: aerobic training

wait list control

PLACEBO COMPARATOR

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

Behavioral: Wait list

Interventions

aerobic trainingBEHAVIORAL

12 weeks of aerobic training, 4 times/week

Also known as: Training, aerobic
aerobic training
Wait listBEHAVIORAL

wait list control condition

Also known as: Condition, wait list control
wait list control

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

  • 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.

    PMID: 17626836RESULT

  • 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.

    PMID: 33337592DERIVED

  • 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.

    PMID: 31916828DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Richard P Sloan, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 14, 2010

First Posted

April 14, 2011

Study Start

January 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 11, 2018

Record last verified: 2018-06

Locations

US(1)