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Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans (VINE)

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ClinicalTrials.gov Identifier: NCT01024634
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : December 17, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bo Fernhall, University of Illinois at Urbana-Champaign

Tracking Information
First Submitted Date  ICMJE December 2, 2009
First Posted Date  ICMJE December 3, 2009
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Arterial function [ Time Frame: Pre, following a 4 week control period and after 8 weeks of exercise intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Autonomic function [ Time Frame: Pre, following a 4 week control period and following 8 weeeks of an exercise intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans
Official Title  ICMJE Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans
Brief Summary The purpose of this study is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians.
Detailed Description African-Americans are at greater risk than Caucasians for developing hypertension, cardiovascular disease, stroke and renal disease. This is likely related to arterial dysfunction including greater arterial stiffness, and reduced microvascular reactivity of resistance arteries in African-Americans. In addition, African-Americans have higher levels of inflammatory markers, and a greater sympathoexcitatory response to various stressors. This imbalance between sympathetic and reduced parasympathetic activation may directly affect vascular function and potentiate a greater inflammatory response, further altering key structural and functional properties of the vascular wall. The overall aim of this proposal is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians. We will examine these effects at rest and following a high intensity (maximal cycle ergometry) sympathoexcitation at both pre- and post-intervention time points, since sympathoexcitation may elucidate changes not evident at rest. Because African-Americans have higher levels of arterial stiffness, lower microvascular reactivity, greater responses to sympathoexcitation, greater levels of inflammatory markers and greater vasoconstrictive tone, we hypothesize that African-Americans will show differential responses to exercise training and benefit more compared to a matched group of Caucasians.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Vascular Health
  • Autonomic Function
Intervention  ICMJE Behavioral: Endurance Exercise
8 weeks of Endurance exercise training, 3-4 times per week, 45-60 minutes perr session
Study Arms  ICMJE
  • African American Group
    A group of young African American males and females
    Intervention: Behavioral: Endurance Exercise
  • Caucasian Group
    a group of young Caucasian men and women
    Intervention: Behavioral: Endurance Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
91
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)
80
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects in good health with no cardiovascular, metabolic, or inflammatory disease, who do not use cardiovascular medications or antioxidant vitamin supplementation, including use of anti-inflammatory (including aspirin) or steroidal substances in the past 2 months will be inlcuded

Exclusion Criteria:

  • Subjects who smoke, are severely obese (body mass index > 35 kg/m2), or who have hypertension (blood pressure >140/90mmHg), diabetes (fasting glucose >110mg/dl), hyperlipidemia, inflammatory disease (rheumatoid arthritis and systemic lupus erythematosus, etc) or diagnosed cardiovascular disease including, coronary heart disease, hypertension and cardiac arrhythmia or renal disease, will be excluded
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024634
Other Study ID Numbers  ICMJE UIUC 09599
1R01HL093249-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bo Fernhall, University of Illinois at Urbana-Champaign
Study Sponsor  ICMJE University of Illinois at Urbana-Champaign
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Bo Fernhall, Ph.D. University of Illinois at Urbana-Champaign
PRS Account University of Illinois at Urbana-Champaign
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP