NCT01576913

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

1.1 years

First QC Date

April 11, 2012

Last Update Submit

November 22, 2014

Conditions

Exercise Testing With Music Pacing

Keywords

exercise testingmusicVO2 max

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • peak power

    exercise test duration, approx.10 minutes

  • anaerobic threshold

    exercise test duration, approx.10 minutes

  • rating of perceived exertion

    exercise test duration, approx.10 minutes

  • mechanical efficiency

    exercise test duration, approx.10 minutes

  • cadence

    exercise test duration, approx.10 minutes

Study Arms (2)

Music pacing

ACTIVE COMPARATOR

Exercise testing with music pacing

Other: Music listening

No music pacing

NO INTERVENTION

Exercise testing without music pacing

Interventions

Music listeningOTHER

Listening to tempo music while cycling in an exercise test

Music pacing

Eligibility Criteria

Age8 Years - 12 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • male sex
  • currently and generally healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba_Medical_Center

Ramat Gan, Israel

Location

Study Officials

  • Gal Dubnov-Raz, MD, MSc

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior physician

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 13, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

IL(1)