Healthy ChildrenNCT01829438
Influence of Music on 6 Minutes Walking Distance in Healthy Children
A study testing Listening to fast music, Listening to preferred music and Listening to slow music in people with Healthy Children, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred) on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen saturation) in healthy children. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Listening to fast music, Listening to preferred music and Listening to slow music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Jun 2011
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- the participation to the physical education program after the annual medical investigation
Who cannot join
- a lung disease
- an overweight
- a motor disability based on parent's answers to a questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Distractive Auditory Stimulus on 6 Minute Walking Test in Healthy Children
To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred) on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen saturation) in healthy children.
- Conditions
- Healthy Children
- Being tested
- Listening to fast music, Listening to preferred music, Listening to slow music
- Keywords
- exercise tolerance, 6MWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to fast musicBehavioural
Also called Listening to fast music during the test
Listening to preferred musicBehavioural
Also called Listening to preferred music during the 6MWT
Listening to slow musicBehavioural
Also called Listening to preferred music during the 6MWT
| Study group | Role | What they receive |
|---|---|---|
| Without music | No intervention | 6MWT without music |
| With fast music | Experimental | 6MWT with a fast music Receives: Behavioral: Listening to fast music |
| With slow music | Experimental | 6MWT with a slow music Receives: Behavioral: Listening to slow music |
| With preferred music | Experimental | 6MWT with the preferred music of the child Receives: Behavioral: Listening to preferred music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walked distance
The distance walked by subjects during a 6 minutes walking test
Measured: After 6 minutes
Secondary outcomes (1)
Dyspnea
Dyspnea is measured by a visual analogue scale
Measured: At the end of the 6MWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Lux Amandine, Student, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829438
- Sponsor's protocol ID
- 6MWT
- Status last verified
- Apr 2013
- First submitted
- 9 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Distractive Auditory Stimulus on 6 Minute Walking Test in Healthy Children
- ClinicalTrials.gov ID
- NCT01829438
- Acronym / sponsor ID
- 6MWT
- Conditions
- Healthy Children
- Keywords
- exercise tolerance, 6MWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Apr 2013 (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.
To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred) on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen saturation) in healthy children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Without music | No intervention | –6MWT without music |
| With fast music | Experimental | Behavioral: Listening to fast music6MWT with a fast music |
| With slow music | Experimental | Behavioral: Listening to slow music6MWT with a slow music |
| With preferred music | Experimental | Behavioral: Listening to preferred music6MWT with the preferred music of the child |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- the participation to the physical education program after the annual medical investigation
Key exclusion criteria (3 listed)
- a lung disease
- an overweight
- a motor disability based on parent's answers to a questionnaire
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 |
|---|---|---|
| Listening to fast musicAlso: Listening to fast music during the test | Behavioural | With fast music |
| Listening to preferred musicAlso: Listening to preferred music during the 6MWT | Behavioural | With preferred music |
| Listening to slow musicAlso: Listening to preferred music during the 6MWT | Behavioural | With slow music |
Primary outcome
Walked distance
Time frame: After 6 minutes
The distance walked by subjects during a 6 minutes walking test
1 secondary outcome
Dyspnea
Time frame: At the end of the 6MWT
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 11 Apr 2013.
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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.
Lux Amandine, Student principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to fast music, Listening to preferred music and Listening to slow music in people with Healthy Children, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 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 11 Apr 2013. 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 Belgium. 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?
Walked distance (time frame: After 6 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 11 Apr 2013.