NCT01829438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

Same day

First QC Date

April 9, 2013

Last Update Submit

April 10, 2013

Conditions

Healthy Children

Keywords

exercise tolerance6MWT

Outcome Measures

Primary Outcomes (1)

  • Walked distance

    The distance walked by subjects during a 6 minutes walking test

    After 6 minutes

Secondary Outcomes (1)

  • Dyspnea

    At the end of the 6MWT

Other Outcomes (1)

  • cardio-respiratory parameters

    at the begining and the end of the 6MWT

Study Arms (4)

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

Listening to fast musicBEHAVIORAL
Also known as: Listening to fast music during the test
With fast music
Listening to preferred musicBEHAVIORAL
Also known as: Listening to preferred music during the 6MWT
With preferred music
Listening to slow musicBEHAVIORAL
Also known as: Listening to preferred music during the 6MWT
With slow music

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • the participation to the physical education program after the annual medical investigation

You may not qualify if:

  • a lung disease
  • an overweight
  • a motor disability based on parent's answers to a questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL

Brussels, 1200, Belgium

Location

Study Officials

  • Lux Amandine, Student

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Physiotherapy

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

June 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

BE(1)