Influence of Music on 6 Minutes Walking Distance in Healt... | NCT01829438

Studies
Influence of Music on 6 Minutes Walking Distance in Healthy Children

NCT01829438

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Apr 11, 2013Estimated

Enrollment

97Actual

Phase

Not Applicable

Conditions

Healthy Children

Interventions

Listening to fast music
Listening to preferred music
Listening to slow music

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2011Actual

First Submitted Date

Apr 9, 2013

First Submission Date that Met QC Criteria

Apr 10, 2013

First Posted Date

Apr 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2013

Last Update Posted Date

Apr 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

G.Reychler, Doctor in Physiotherapy, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Without music	No Intervention	6MWT without music
With fast music	Experimental	6MWT with a fast music	Behavioral: Listening to fast music
With slow music	Experimental	6MWT with a slow music	Behavioral: Listening to slow music
With preferred music	Experimental	6MWT with the preferred music of the child	Behavioral: Listening to preferred music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Listening to fast music	Behavioral		With fast music	Listening to fast music during the test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Walked distance	The distance walked by subjects during a 6 minutes walking test	After 6 minutes

Secondary Outcomes

Measure	Description	Time Frame
Dyspnea	Dyspnea is measured by a visual analogue scale	At the end of the 6MWT

Other Outcomes

Measure	Description	Time Frame
cardio-respiratory parameters	Heart rate and oxygen saturation are measured before and after the test	at the begining and the end of the 6MWT

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided