HealthyNCT02318238
Comparison Between 6 Minute Walk Test, 6 Minute Step Test and 4 Metre Gait Speed
A study testing 6 minutes walking test, 6 minutes step test and 4 meters gait speed in people with Healthy and Children, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- What is being tested?
- 6 minutes walking test, 6 minutes step test and 4 meters gait speed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy
Who cannot join
- a lung disease
- an overweight
- an orthopedic disability which can slow down the subject during tests execution
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- 6 minutes walking test, 6 minutes step test, 4 meters gait speed
- Keywords
- evaluation, exercise tolerance, healthy children, 6MWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minutes walking testOther
Also called walk during 6 minutes as fast as possible
6 minutes step testOther
Also called up and down a step during 6 minutes as fast as possible
4 meters gait speedOther
Also called walk a four metre distance
| Study group | Role | What they receive |
|---|---|---|
| 6 minute walking test | Active comparator | walking during 6 minutes Receives: Other: 6 minutes walking test |
| 6 minute step test | Experimental | stepping during 6 minutes Receives: Other: 6 minutes step test |
| 4 meter gait speed | Experimental | walking as fast as possible on 4 meters Receives: Other: 4 meters gait speed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walked distance
The distance walked by subjects during a 6 minute walk test
Measured: At 6 minutes
Steps count
Steps number raised and lowered by subject during a 6 minute step test
Measured: At 6 minutes
Time
Time to walk four metres
Measured: at 1 minute
6MWT speed
Subjects speed (number of metres/minute) during the 6 minute walk test
Measured: at 6 minutes
6MST speed
Number of steps/minute during the 6 minute step test
Measured: at 6 minutes
4MGS speed
Number of metres/second during the four metre gait speed
Measured: at 1 minute
Secondary outcomes (4)
Dyspnea
Dyspnea is measured by a visual analogue scale
Measured: at 6 minutes
Perceived exertion
Percieve exertion is measured by a perceive exertion scale
Measured: at 6 minutes
Heart rate
Heart rate was measured after each test
Measured: at 6 minutes
Oxygen saturation
Oxygen saturation was measured after each test
Measured: at 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Sophie De Wulf, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318238
- Sponsor's protocol ID
- FT001
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 6 Minute Walk Test, 6 Minute Step Test and 4 Metre Gait Speed
- ClinicalTrials.gov ID
- NCT02318238
- Acronym / sponsor ID
- FT001
- Keywords
- evaluation, exercise tolerance, healthy children, 6MWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 minute walking test | Active comparator | Other: 6 minutes walking testwalking during 6 minutes |
| 6 minute step test | Experimental | Other: 6 minutes step teststepping during 6 minutes |
| 4 meter gait speed | Experimental | Other: 4 meters gait speedwalking as fast as possible on 4 meters |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (3 listed)
- a lung disease
- an overweight
- an orthopedic disability which can slow down the subject during tests execution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 minutes walking testAlso: walk during 6 minutes as fast as possible | Other | 6 minute walking test |
| 6 minutes step testAlso: up and down a step during 6 minutes as fast as possible | Other | 6 minute step test |
| 4 meters gait speedAlso: walk a four metre distance | Other | 4 meter gait speed |
Primary outcome
Walked distance
Time frame: At 6 minutes
The distance walked by subjects during a 6 minute walk test
Steps count
Time frame: At 6 minutes
Steps number raised and lowered by subject during a 6 minute step test
Time
Time frame: at 1 minute
Time to walk four metres
6MWT speed
Time frame: at 6 minutes
Subjects speed (number of metres/minute) during the 6 minute walk test
6MST speed
Time frame: at 6 minutes
Number of steps/minute during the 6 minute step test
4MGS speed
Time frame: at 1 minute
Number of metres/second during the four metre gait speed
4 secondary outcomes
Dyspnea
Time frame: at 6 minutes
Perceived exertion
Time frame: at 6 minutes
Heart rate
Time frame: at 6 minutes
Oxygen saturation
Time frame: at 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie De Wulf principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minutes walking test, 6 minutes step test and 4 meters gait speed in people with Healthy and Children, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walked distance (time frame: At 6 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.