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NCT01829438 Clinical Trial

Influence of Music on 6 Minutes Walking Distance in Healthy Children

Healthy Children Clinical Trial

Official title:
Influence of a Distractive Auditory Stimulus on 6 Minute Walking Test in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01829438
Other study ID # 6MWT
Secondary ID
Status Completed
Phase N/A
First received April 9, 2013
Last updated April 10, 2013
Start date June 2010
Est. completion date June 2011

Study information
Verified date April 2013
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date June 2011
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 18 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• Listening to fast music

• Listening to preferred music

• Listening to slow music

Locations
Country Name City State
Belgium UCL Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Other cardio-respiratory parameters Heart rate and oxygen saturation are measured before and after the test at the begining and the end of the 6MWT No
Primary Walked distance The distance walked by subjects during a 6 minutes walking test After 6 minutes No
Secondary Dyspnea Dyspnea is measured by a visual analogue scale At the end of the 6MWT No
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