The Diagnostic Performance of Tilt Test in Athletes

October 25, 2017 updated by: Evangelia Kouidi, Aristotle University Of Thessaloniki

The Diagnostic Performance of Tilt Test in Athletes and a Novel Strategy for Its Improvement

In the present study the investigators evaluate the sensitivity and specificity of passive tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for the improvement of diagnostic yield of tilt test in athletes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We examine athletes with a history of reflex syncope and athletes without history of reflex syncope.All subjects undergo a tilt test, for the evaluation of haemodynamics, heart rate variability (HRV) and baroreflex sensitivity.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

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

      • Thessaloniki, Greece, 54622
        • Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece

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

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 14-40 years old,
  • more than 5 years of exercise training experience and competition at a regional level at different sports

Exclusion Criteria:

  • smoking,
  • recent alcohol consumption,
  • presence of any chronic disease and use of drugs

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: History of reflex syncope
Passive tilt test in athletes with a history of reflex syncope
Passive tilt test (without pharmacological provocation). After a horizontal supine rest period of 5 min, the tilt table was inclined at 60° head-up position for 30 min. A positive response was defined according to the European Society of Cardiology guidelines for the diagnosis and management of syncope
Other: No history of reflex syncope
Passive tilt test in athletes without history of reflex syncope
Passive tilt test (without pharmacological provocation). After a horizontal supine rest period of 5 min, the tilt table was inclined at 60° head-up position for 30 min. A positive response was defined according to the European Society of Cardiology guidelines for the diagnosis and management of syncope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity of tilt test in athletes as measured by the occurence of syncope/presyncope during tilt test
Time Frame: 30 min
sensitivity = number of subjects with syncope/presyncope during tilt test/ number of subjects with a history of reflex syncope, specificity = number of subjects without syncope/presyncope during tilt test/ number of subjects without history of reflex syncope
30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameters of haemodynamics during tilt test
Time Frame: 30 min
We investigate whether the mean values of parameters of haemodynamics during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope
30 min
Parameters of heart rate variability during tilt test
Time Frame: 30 min
We investigate whether the mean values of parameters of heart rate variability during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope
30 min
Parameters of baroreflex sensitivity during tilt test
Time Frame: 30 min
We investigate whether the mean values of parameters of baroreflex sensitivity during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope
30 min

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Evangelia Kouidi, Professor, Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece

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, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 6, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

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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