Healthy Clinical Trial
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.
| 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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Clinique universitaire Saint-Luc | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
| 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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