CompletedNCT03276299Updated Sep 8, 2017

Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years

An interventional study of six minute walking test and six minute walking test in Healthy Children, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-08.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 148
Allocation: Randomized
Ages: 6 Years to 12 Years
Sex: All

Study summary

Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years

Conditions studied

Healthy Children

Who can participate

Ages eligible: 6 Years to 12 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

healthy subjects

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Outcomes assessor)
Enrollment: 148 participants (actual)

Study arms

Active comparator
test 1
six minute walking test
Other: six minute walking test
Experimental
test 2
six minute walking test
Other: six minute walking test
Experimental
test with encouragement
six minute walking test
Other: six minute walking test
Active comparator
test without encouragement
six minute walking test
Other: six minute walking test

Interventions

Othersix minute walking test
six minute walking test
Othersix minute walking test
six minute walking test with encouragement

What researchers measure

Primary outcomes

distance
walked distance
Time frame: six minutes

Secondary outcomes

heart rate
heart rate
Time frame: six minutes
pulsed oxygen saturation
pulsed oxygen saturation
Time frame: six minutes

Study locations

1 site

Clinique universitaire Saint-Luc
Brussels, Belgium

References and documents

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 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03276299
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party: Sponsor
First posted: Sep 8, 2017
Start date: Dec 2015
Primary completion: Dec 2015
Completion: Dec 2016
Last update: Sep 8, 2017

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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