Healthy ChildrenNCT03276299
Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years
A study testing six minute walking test in people with Healthy Children, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- six minute walking test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2015to Dec 2016
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy subjects
Who cannot join
- acute or chronic lung, cardiac or neuromuscular disease
- at risk of- or overweight (BMI higher than 85th percentile for children of the same age and sex)
- a motor disability
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years
- Conditions
- Healthy Children
- Being tested
- six minute walking test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
six minute walking testOther
six minute walking test
six minute walking testOther
six minute walking test with encouragement
| Study group | Role | What they receive |
|---|---|---|
| test 1 | Active comparator | six minute walking test Receives: Other: six minute walking test |
| test 2 | Experimental | six minute walking test Receives: Other: six minute walking test |
| test with encouragement | Experimental | six minute walking test Receives: Other: six minute walking test |
| test without encouragement | Active comparator | six minute walking test Receives: Other: six minute walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
distance
walked distance
Measured: six minutes
Secondary outcomes (2)
heart rate
heart rate
Measured: six minutes
pulsed oxygen saturation
pulsed oxygen saturation
Measured: six minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276299
- Sponsor's protocol ID
- Child6MWT
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morales Mestre N, Audag N, Caty G, Reychler G. Learning and Encouragement Effects on Six-Minute Walking Test in Children. J Pediatr. 2018 Jul;198:98-103. doi: 10.1016/j.jpeds.2018.02.073. Epub 2018 Apr 24.
PubMed 29703575
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years
- ClinicalTrials.gov ID
- NCT03276299
- Acronym / sponsor ID
- Child6MWT
- Conditions
- Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Sep 2017 (actual)
- 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.
Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| test 1 | Active comparator | Other: six minute walking testsix minute walking test |
| test 2 | Experimental | Other: six minute walking testsix minute walking test |
| test with encouragement | Experimental | Other: six minute walking testsix minute walking test |
| test without encouragement | Active comparator | Other: six minute walking testsix minute walking test |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (3 listed)
- acute or chronic lung, cardiac or neuromuscular disease
- at risk of- or overweight (BMI higher than 85th percentile for children of the same age and sex)
- a motor disability
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 |
|---|---|---|
| six minute walking testsix minute walking test | Other | test 1, test 2, test without encouragement |
| six minute walking testsix minute walking test with encouragement | Other | test with encouragement |
Primary outcome
distance
Time frame: six minutes
walked distance
2 secondary outcomes
heart rate
Time frame: six minutes
pulsed oxygen saturation
Time frame: six 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 8 Sep 2017.
- Derived from this study: PubMed 29703575Morales Mestre N, Audag N, Caty G, Reychler G. Learning and Encouragement Effects on Six-Minute Walking Test in Children. J Pediatr. 2018 Jul;198:98-103. doi: 10.1016/j.jpeds.2018.02.073. Epub 2018 Apr 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing six minute walking test in people with Healthy 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 8 Sep 2017. 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?
distance (time frame: six minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276299, which also lists 1 linked publication.
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 8 Sep 2017.