- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01829438
Influence of Music on 6 Minutes Walking Distance in Healthy Children
April 10, 2013 updated by: G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, 1200
- UCL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the participation to the physical education program after the annual medical investigation
Exclusion Criteria:
- a lung disease
- an overweight
- a motor disability based on parent's answers to a questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Without music
6MWT without music
|
|
Experimental: With fast music
6MWT with a fast music
|
Other Names:
|
Experimental: With slow music
6MWT with a slow music
|
Other Names:
|
Experimental: With preferred music
6MWT with the preferred music of the child
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walked distance
Time Frame: After 6 minutes
|
The distance walked by subjects during a 6 minutes walking test
|
After 6 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: At the end of the 6MWT
|
Dyspnea is measured by a visual analogue scale
|
At the end of the 6MWT
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardio-respiratory parameters
Time Frame: at the begining and the end of the 6MWT
|
Heart rate and oxygen saturation are measured before and after the test
|
at the begining and the end of the 6MWT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lux Amandine, Student, UCL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 9, 2013
First Submitted That Met QC Criteria
April 10, 2013
First Posted (Estimate)
April 11, 2013
Study Record Updates
Last Update Posted (Estimate)
April 11, 2013
Last Update Submitted That Met QC Criteria
April 10, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6MWT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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