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Gene - Exercise Research Study (GERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00976742
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : September 14, 2009
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by:
University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Last Update Posted Date September 14, 2009
Study Start Date  ICMJE June 1998
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Cardiovascular Disease Risk Factors [ Time Frame: ~9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gene - Exercise Research Study
Official Title  ICMJE Impact of Common Genetic Polymorphisms on CV Disease Risk Factor Changes With Endurance Exercise Training
Brief Summary The investigators hypothesize that the degree to which older generally healthy but sedentary men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of highly-standardized endurance exercise training will be a function of common genetic variations in candidate genes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease Risk Factors
Intervention  ICMJE Behavioral: Endurance exercise training
Study Arms  ICMJE Experimental: Endurance Exercise Training
Intervention: Behavioral: Endurance exercise training
Publications * Halverstadt A, Phares DA, Wilund KR, Goldberg AP, Hagberg JM. Endurance exercise training raises high-density lipoprotein cholesterol and lowers small low-density lipoprotein and very low-density lipoprotein independent of body fat phenotypes in older men and women. Metabolism. 2007 Apr;56(4):444-50.

*   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: September 11, 2009)
225
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • generally healthy
  • free from CV disease
  • ability to undergo exercise training

Exclusion Criteria:

  • previous history of CV disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00976742
Other Study ID Numbers  ICMJE AG17474
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Hagberg, PhD, Professor, Principal Investigator, University of Maryland College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE Not Provided
PRS Account University of Maryland, College Park
Verification Date September 2009

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