Music Pacing in Pediatric Exercise Testing

November 22, 2014 updated by: Gal Raz-Dubnov MD, MSc, Sheba Medical Center

Study hypothesis: Music pacing improves the quality of exercise testing in children.

Children tend to cycle in a non-constant pace during exercise testing, which might make the test less reliable.

20 boys will perform two exercise tests on a cycle ergometer. One test will be done with constant tempoed music, and the other without. Different parameters will be checked including pedaling cadence, aerobic fitness, level of work load obtained.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Israel
      • Ramat Gan, Israel
        • Sheba_Medical_Center

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male sex
  • currently and generally healthy

Exclusion Criteria:

  • presence of chronic disease/ medication use
  • BMI above 85%
  • trained/competitive cyclists

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Music pacing
Exercise testing with music pacing
Other: Music listening
Listening to tempo music while cycling in an exercise test
No Intervention: No music pacing
Exercise testing without music pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peak VO2
Time Frame: end of the exercise test, approx.10 minutes
peak Vo2 is the maximal oxygen consumption obtained during the exercise test, reflecting the level of aerobic fintess
end of the exercise test, approx.10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peak power
Time Frame: exercise test duration, approx.10 minutes
maximal power obtained at the end of the exercise test
exercise test duration, approx.10 minutes
anaerobic threshold
Time Frame: exercise test duration, approx.10 minutes
point of increase in anaerobic metabolism
exercise test duration, approx.10 minutes
rating of perceived exertion
Time Frame: exercise test duration, approx.10 minutes
scale of perceived effort
exercise test duration, approx.10 minutes
mechanical efficiency
Time Frame: exercise test duration, approx.10 minutes
oxygen consumption per work load
exercise test duration, approx.10 minutes
cadence
Time Frame: exercise test duration, approx.10 minutes
pedaling rate
exercise test duration, approx.10 minutes

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Gal Dubnov-Raz, MD, MSc, Sheba Medical Center

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

April 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 22, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-12-9340-GDR-CTIL

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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