PD2i Analysis of Heart Rate Variability in Competitive Sports

Completed

• Conditions: Autonomic Dysfunction
• Interventions: Device: PD2i Analyzer

• Registration Number: NCT01249248
• Lead Sponsor: University of Mississippi Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-11
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-26
• Study First Posted: 2010-11-29
• Study Completion: 2011-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female vollyball players	PD2i Analyzer	-
Female basketball players	PD2i Analyzer	-
Football players	PD2i Analyzer	-
Baseball players	PD2i Analyzer	-
Softball players	PD2i Analyzer	-
Male basketball players	PD2i Analyzer	-
Male soccer players	PD2i Analyzer	-
Female soccer players	PD2i Analyzer	-

Primary Outcome Measures

Name	Time	Method
Change in PD2i following strenuous exercise bout of 45 minutes	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

Name	Time	Method
Change in PD2i following an injury during competitive sports.	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.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States