PD2i Analysis of Heart Rate Variability in Competitive Sports

NCT01249248 | Completed DMC

• 1 other identifier: 2010-0158
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Dysfunction

Keywords

Heart rate variability; Autonomic dysfunction; Exercise; Sports; Competition; Athletes

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Change in PD2i following an injury during competitive sports.

  Baseline PD2i at zero and within 60 minutes of cessation of exercise bout.

Study Arms (8)

Male basketball players

Device: PD2i Analyzer

Female basketball players

Device: PD2i Analyzer

Baseball players

Device: PD2i Analyzer

Softball players

Device: PD2i Analyzer

Football players

Device: PD2i Analyzer

Female vollyball players

Device: PD2i Analyzer

Male soccer players

Device: PD2i Analyzer

Female soccer players

Device: PD2i Analyzer

Interventions

PD2i Analyzer DEVICE

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

Baseball players; Female basketball players; Female soccer players; Female vollyball players; Football players; Male basketball players; Male soccer players; Softball players

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

College athletes on competitive teams.

You may qualify if:

• Age \>18 years, as determined by birth date given on participation form.
• Actively involved in competitive athletics
• Able to give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Vicor Technologies, Inc.: collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Primary Dysautonomias; Motor Activity

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Steve A Watts, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 29, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2011
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

US (1)