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

April 10, 2012 updated by: James Hughes, University of Mississippi Medical Center
This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

College athletes on competitive teams.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline at zero minutes and within 60 minutes of completion of strenuous exercise bout.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline PD2i at zero and within 60 minutes of cessation of exercise bout.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Collaborators

Vicor Technologies, Inc.

Investigators

  • Principal Investigator: Steve A Watts, MD, University of Mississippi Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 26, 2010

First Posted (ESTIMATE)

November 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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