Exercise Testing With Music PacingNCT01576913
Music Pacing in Pediatric Exercise Testing
A study testing Music listening in people with Exercise Testing With Music Pacing, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Testing With Music Pacing
- What is being tested?
- Music listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- male sex
- currently and generally healthy
Who cannot join
- presence of chronic disease/ medication use
- BMI above 85%
- trained/competitive cyclists
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Exercise Testing With Music Pacing
- Being tested
- Music listening
- Keywords
- exercise testing, music, VO2 max
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningOther
Listening to tempo music while cycling in an exercise test
| Study group | Role | What they receive |
|---|---|---|
| Music pacing | Active comparator | Exercise testing with music pacing Receives: Other: Music listening |
| No music pacing | No intervention | Exercise testing without music pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak VO2
peak Vo2 is the maximal oxygen consumption obtained during the exercise test, reflecting the level of aerobic fintess
Measured: end of the exercise test, approx.10 minutes
Secondary outcomes (5)
peak power
maximal power obtained at the end of the exercise test
Measured: exercise test duration, approx.10 minutes
anaerobic threshold
point of increase in anaerobic metabolism
Measured: exercise test duration, approx.10 minutes
rating of perceived exertion
scale of perceived effort
Measured: exercise test duration, approx.10 minutes
mechanical efficiency
oxygen consumption per work load
Measured: exercise test duration, approx.10 minutes
cadence
pedaling rate
Measured: exercise test duration, approx.10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Testing With Music PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gal Raz-Dubnov MD, MSc, Sheba Medical Center
- Investigators
- Gal Dubnov-Raz, MD, MSc, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576913
- Sponsor's protocol ID
- SHEBA-12-9340-GDR-CTIL
- Status last verified
- Nov 2014
- First submitted
- 11 Apr 2012
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Pacing in Pediatric Exercise Testing
- ClinicalTrials.gov ID
- NCT01576913
- Acronym / sponsor ID
- SHEBA-12-9340-GDR-CTIL
- Conditions
- Exercise Testing With Music Pacing
- Keywords
- exercise testing, music, VO2 max
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music pacing | Active comparator | Other: Music listeningExercise testing with music pacing |
| No music pacing | No intervention | –Exercise testing without music pacing |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- male sex
- currently and generally healthy
Key exclusion criteria (3 listed)
- presence of chronic disease/ medication use
- BMI above 85%
- trained/competitive cyclists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music listeningListening to tempo music while cycling in an exercise test | Other | Music pacing |
Primary outcome
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
5 secondary outcomes
peak power
Time frame: exercise test duration, approx.10 minutes
anaerobic threshold
Time frame: exercise test duration, approx.10 minutes
rating of perceived exertion
Time frame: exercise test duration, approx.10 minutes
mechanical efficiency
Time frame: exercise test duration, approx.10 minutes
cadence
Time frame: exercise test duration, approx.10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gal Dubnov-Raz, MD, MSc principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Exercise Testing With Music Pacing, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak VO2 (time frame: end of the exercise test, approx.10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.