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PD2i Analysis of Heart Rate Variability in Competitive Sports (PACA)

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ClinicalTrials.gov Identifier: NCT01249248
Recruitment Status : Completed
First Posted : November 29, 2010
Last Update Posted : April 12, 2012
Sponsor:
Collaborator:
Vicor Technologies, Inc.
Information provided by (Responsible Party):
James Hughes, University of Mississippi Medical Center

Study Description
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Brief Summary:
This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition.

Condition or disease Intervention/treatment
Autonomic Dysfunction Device: PD2i Analyzer

Study Design
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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PD2i Analysis of Heart Rate Variability in Competitive Sports
Study Start Date : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : July 2011
Groups and Cohorts
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Group/Cohort Intervention/treatment
Male basketball players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Female basketball players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Baseball players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Softball players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Football players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Female vollyball players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Male soccer players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Female soccer players Device: PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes


Outcome Measures
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Primary Outcome Measures :
  1. Change in PD2i following strenuous exercise bout of 45 minutes [ Time Frame: Baseline at zero minutes and within 60 minutes of completion of strenuous exercise bout. ]
    PD2i analysis of HRV measured before and after strenuous exercise in each sport. The change from baseline will be correlated to return to resting heart rate.


Secondary Outcome Measures :
  1. Change in PD2i following an injury during competitive sports. [ Time Frame: Baseline PD2i at zero and within 60 minutes of cessation of exercise bout. ]
    If an athlete participating in the research sustains an injury the PD2i analysis will be obtained and correlated to the baseline analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
College athletes on competitive teams.
Criteria

Inclusion Criteria:

  • Age >18 years, as determined by birth date given on participation form.
  • Actively involved in competitive athletics
  • Able to give informed consent

Exclusion Criteria:

  • Any known prior autonomic dysfunction
  • History of seizures or taking anti-seizure medication
  • Known learning disability or attention deficit disorder
  • Chronic heart conditions such as arrhythmias or valvular disease
  • History of diabetes mellitus
  • Taking any prescription stimulants such as Ritalin, Focalin, etc.
  • Use of any performance-enhancing drugs
  • Any deviation from normal found on the pre-participation physical exam such as the presence of a murmur or hypertension.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249248


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Vicor Technologies, Inc.
Investigators
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Principal Investigator: Steve A Watts, MD University of Mississippi Medical Center
More Information
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Responsible Party: James Hughes, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01249248    
Other Study ID Numbers: 2010-0158
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012
Keywords provided by James Hughes, University of Mississippi Medical Center:
Heart rate variability
Autonomic dysfunction
Exercise
 Sports
Competition
Athletes
Additional relevant MeSH terms:
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Autonomic Nervous System Diseases
Primary Dysautonomias
Nervous System Diseases