- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02318238
Comparison Between 6 Minute Walk Test, 6 Minute Step Test and 4 Metre Gait Speed
December 11, 2014 updated by: G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium
- Clinique Universitaire Saint-Luc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy
Exclusion Criteria:
- a lung disease
- an overweight
- an orthopedic disability which can slow down the subject during tests execution
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 6 minute walking test
walking during 6 minutes
|
Other Names:
|
Experimental: 6 minute step test
stepping during 6 minutes
|
Other Names:
|
Experimental: 4 meter gait speed
walking as fast as possible on 4 meters
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walked distance
Time Frame: At 6 minutes
|
The distance walked by subjects during a 6 minute walk test
|
At 6 minutes
|
Steps count
Time Frame: At 6 minutes
|
Steps number raised and lowered by subject during a 6 minute step test
|
At 6 minutes
|
Time
Time Frame: at 1 minute
|
Time to walk four metres
|
at 1 minute
|
6MWT speed
Time Frame: at 6 minutes
|
Subjects speed (number of metres/minute) during the 6 minute walk test
|
at 6 minutes
|
6MST speed
Time Frame: at 6 minutes
|
Number of steps/minute during the 6 minute step test
|
at 6 minutes
|
4MGS speed
Time Frame: at 1 minute
|
Number of metres/second during the four metre gait speed
|
at 1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: at 6 minutes
|
Dyspnea is measured by a visual analogue scale
|
at 6 minutes
|
Perceived exertion
Time Frame: at 6 minutes
|
Percieve exertion is measured by a perceive exertion scale
|
at 6 minutes
|
Heart rate
Time Frame: at 6 minutes
|
Heart rate was measured after each test
|
at 6 minutes
|
Oxygen saturation
Time Frame: at 6 minutes
|
Oxygen saturation was measured after each test
|
at 6 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sophie De Wulf, UCL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
December 4, 2014
First Submitted That Met QC Criteria
December 11, 2014
First Posted (Estimate)
December 17, 2014
Study Record Updates
Last Update Posted (Estimate)
December 17, 2014
Last Update Submitted That Met QC Criteria
December 11, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FT001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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