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

This study has been completed.
Sponsor:
Collaborator:
Vicor Technologies, Inc.
Information provided by (Responsible Party):
James Hughes, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01249248
First received: November 24, 2010
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Autonomic Dysfunction
 Device: PD2i Analyzer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PD2i Analysis of Heart Rate Variability in Competitive Sports

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Mississippi Medical Center:

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


Enrollment: 90
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249248

Locations
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
Principal Investigator: Steve A Watts, MD University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: James Hughes, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01249248     History of Changes
Other Study ID Numbers: 2010-0158
Study First Received: November 24, 2010
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Heart rate variability
Autonomic dysfunction
Exercise
 Sports
Competition
Athletes

ClinicalTrials.gov processed this record on June 17, 2013