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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01576913
Other study ID # SHEBA-12-9340-GDR-CTIL
Secondary ID
Status Completed
Phase N/A
First received April 11, 2012
Last updated November 22, 2014
Start date April 2012
Est. completion date May 2013

Study information

Verified date November 2014
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- male sex

- currently and generally healthy

Exclusion Criteria:

- presence of chronic disease/ medication use

- BMI above 85%

- trained/competitive cyclists

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)


Related Conditions & MeSH terms

  • Exercise Testing With Music Pacing

Intervention

Other:
Music listening
Listening to tempo music while cycling in an exercise test

Locations

Country Name City State
Israel Sheba_Medical_Center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary peak VO2 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 No
Secondary peak power maximal power obtained at the end of the exercise test exercise test duration, approx.10 minutes No
Secondary anaerobic threshold point of increase in anaerobic metabolism exercise test duration, approx.10 minutes No
Secondary rating of perceived exertion scale of perceived effort exercise test duration, approx.10 minutes No
Secondary mechanical efficiency oxygen consumption per work load exercise test duration, approx.10 minutes No
Secondary cadence pedaling rate exercise test duration, approx.10 minutes No