PD2i Analysis of Heart Rate Variability in Competitive Sports

Autonomic Dysfunction Clinical Trial

— PACA  

Official title:

PD2i Analysis of Heart Rate Variability in Competitive Sports

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249248
• Other study ID #: 2010-0158
• Status: Completed
• Phase: N/A
• First received: November 24, 2010
• Last updated: April 10, 2012
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2012
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Primary Dysautonomias

Intervention

Device:
• PD2i Analyzer
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Vicor Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PD2i following strenuous exercise bout of 45 minutes	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.	Yes
Secondary	Change in PD2i following an injury during competitive sports.	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.	Yes