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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02318238
Other study ID # FT001
Secondary ID
Status Completed
Phase N/A
First received December 4, 2014
Last updated December 11, 2014
Start date February 2014
Est. completion date October 2014

Study information

Verified date December 2014
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

The purpose of this study is to find an alternative to the six minute walk test by validating six minute step test and four metre gait speed in healthy children. Both tests were previously validated in adults and are easier to achieve in non-hospital settings.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date October 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria:

- healthy

Exclusion Criteria:

- a lung disease

- an overweight

- an orthopedic disability which can slow down the subject during tests execution

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
6 minutes walking test

6 minutes step test

4 meters gait speed


Locations

Country Name City State
Belgium Clinique universitaire Saint-Luc 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
Primary Walked distance The distance walked by subjects during a 6 minute walk test At 6 minutes No
Primary Steps count Steps number raised and lowered by subject during a 6 minute step test At 6 minutes No
Primary Time Time to walk four metres at 1 minute No
Primary 6MWT speed Subjects speed (number of metres/minute) during the 6 minute walk test at 6 minutes No
Primary 6MST speed Number of steps/minute during the 6 minute step test at 6 minutes No
Primary 4MGS speed Number of metres/second during the four metre gait speed at 1 minute No
Secondary Dyspnea Dyspnea is measured by a visual analogue scale at 6 minutes No
Secondary Perceived exertion Percieve exertion is measured by a perceive exertion scale at 6 minutes No
Secondary Heart rate Heart rate was measured after each test at 6 minutes No
Secondary Oxygen saturation Oxygen saturation was measured after each test at 6 minutes No
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