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Cardiovascular DiseaseNCT01335737

Exercise and Inflammation

A study testing aerobic training and Wait list in people with Cardiovascular Disease, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
aerobic training and Wait list
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
241 participants
Where
1 siteUnited States
Study dates
Jan 2010to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Use of anti-psychotic medications
  • Current of past major depressive disorder, or total symptom score > 10
  • BMI<18
  • Heart disease
  • Hypertension
  • Diabetes mellitus
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: Exercise and Inflammation: Autonomic, Affective & Cellular Mechanisms

The purpose of this study is to test the hypothesis that aerobic exercise leads to attenuation of the inflammatory response to lipopolysaccharide (LPS) stimulation.

Read the 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.

Being tested
aerobic training, Wait list
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aerobic trainingBehavioural

    Also called Training, aerobic

    12 weeks of aerobic training, 4 times/week

  • Wait listBehavioural

    Also called Condition, wait list control

    wait list control condition

Study groups in NCT01335737
Study groupRoleWhat they receive
aerobic trainingExperimental12 weeks of aerobic training, 4 times/week
Receives: Behavioral: aerobic training
wait list controlPlacebo comparatorwait list control condition, 12 weeks + 4 to parallel the deconditioning protocol in active intervention group
Receives: Behavioral: Wait list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tumor necrosis factor (TNF-alpha)

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

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

Secondary outcomes (4)

  1. Change in mood, including depressive symptomatology and negative affect

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

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

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

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

  3. TLR-4

    TLR-4 will be measured from blood samples

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

  4. cerebral blood volume (CBV) in the dentate gyrus

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01335737
Sponsor's protocol ID
5948/6956R
Other IDs
HL094423
Status last verified
Jun 2018
First submitted
14 Jul 2010
Last updated
11 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17626836

  • 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.

    PubMed 33337592

  • 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.

    PubMed 31916828

Questions about this trial

What is this clinical trial studying?

A study testing aerobic training and Wait list in people with Cardiovascular Disease, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tumor necrosis factor (TNF-alpha) (time frame: change from before (pre) to after (post) 12 weeks of training & after 4 weeks of post-deconditioning). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01335737, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.

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