Music Pacing in Pediatric Exercise Testing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Gal Raz-Dubnov MD, MSc, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01576913
First received: April 11, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Exercise Testing With Music Pacing
Other: Music listening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Official Title: Music Pacing in Pediatric Exercise Testing

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • peak VO2 [ Time Frame: end of the exercise test, approx.10 minutes ] [ Designated as safety issue: No ]
    peak Vo2 is the maximal oxygen consumption obtained during the exercise test, reflecting the level of aerobic fintess


Secondary Outcome Measures:
  • peak power [ Time Frame: exercise test duration, approx.10 minutes ] [ Designated as safety issue: No ]
    maximal power obtained at the end of the exercise test

  • anaerobic threshold [ Time Frame: exercise test duration, approx.10 minutes ] [ Designated as safety issue: No ]
    point of increase in anaerobic metabolism

  • rating of perceived exertion [ Time Frame: exercise test duration, approx.10 minutes ] [ Designated as safety issue: No ]
    scale of perceived effort

  • mechanical efficiency [ Time Frame: exercise test duration, approx.10 minutes ] [ Designated as safety issue: No ]
    oxygen consumption per work load

  • cadence [ Time Frame: exercise test duration, approx.10 minutes ] [ Designated as safety issue: No ]
    pedaling rate


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male sex
  • currently and generally healthy

Exclusion Criteria:

  • presence of chronic disease/ medication use
  • BMI above 85%
  • trained/competitive cyclists
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576913

Contacts
Contact: Gal Dubnov-Raz, MD, MSc 972-54-4570250 Gal-d@bezeqint.net

Locations
Israel
Sheba_Medical_Center Not yet recruiting
Ramat Gan, Israel
Principal Investigator: Gal Dubnov-Raz, MD, MSc         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Gal Dubnov-Raz, MD, MSc Sheba Medical Center
  More Information

No publications provided

Responsible Party: Gal Raz-Dubnov MD, MSc, senior physician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01576913     History of Changes
Other Study ID Numbers: SHEBA-12-9340-GDR-CTIL
Study First Received: April 11, 2012
Last Updated: April 11, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
exercise testing
music
VO2 max

ClinicalTrials.gov processed this record on July 24, 2014