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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014