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OpenTrials
Completed

NCT Number: NCT01249248

PD2i Analysis of Heart Rate Variability in Competitive Sports

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

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Key information

Conditions

Autonomic Dysfunction Autonomic Nervous System Diseases Behavior Motor Activity Nervous System Diseases Primary Dysautonomias

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PD2i Analyzer

Device

Analysis of heart rate variability from a standard digital ECG for 6-12 minutes

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • Vicor Technologies, Inc.

Registry information

Acronym: PACA

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 29, 2010
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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