Primary objective: To determine reference values for the 6-Minute Walk Test for Dutch healthy children, when the test is performed according to the ATS guidelines.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Verzamelen normwaarden submaximale inspanningstest bij gezonde kinderen.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
The main study parameter /endpoint is the distance covered by the child when
walking on a flat hard surface for the duration of six minutes.
Secondary outcome
Secondary study parameters are:
Heart rate at onset of the test, heart rate on completion of the test, heart
rate at 2 and 5 minutes after completion of the 6MWT.
Other study parameters are:
Age, height, weight, oxygen saturation at onset and on completion of the 6MWT,
oxygen saturation at 2 and 5 minutes after completion of the 6MWT,
parent-questionnaire.
Background summary
The 6 minute walk test (6MWT ) is a widely used test for measuring sub-maximal
exercise capacity, i.e. the functional exercise capacity needed in everyday
life.The 6 MWT measures the distance that the participant can quickly walk on a
flat hard surface in a period of 6 minutes. The test is self-paced. The 6MWT
was originally developed to measure the submaximal level of functional capacity
in adult patients. The American Thoracic Society (ATS) has published guidelines
for performing the 6 MWT with adults in a clinical setting. Nowadays the 6MWT
is used regularly in pediatric populations as well, for example children with
mucopolysaccharidosis, Duchenne muscular dystrophy, spina bifida and children
with malignancies. It is found to be a useful test for children who are
moderately or severely impaired. A number of studies have produced reference
values for children. Two of the studies involved a European cohort. In one of
these the age span is too small. The other European study by Geiger et al
investigated 528 healthy Austrian children. However, in this study the 6MWT was
modified: to overcome lack of motivation children were provided with a
measuring wheel with an instantaneous display of the walking distance. The
reference values published by Geiger et al are therefore not applicable when
the 6MWT is performed according to the ATS guidelines. In addition, living
circumstances in Austria are different in terms of altiitude and also in the
fact that a large part of the population does not live in urban areas.
Study objective
Primary objective:
To determine reference values for the 6-Minute Walk Test for Dutch healthy
children, when the test is performed according to the ATS guidelines.
Study design
The study has a cross-sectional observational design.
Sample size:
The study aims to establish norm values for the 6MWT for the Dutch population.
We propose additional testing of 20 boys and 20 girls aged 4 years en 20 boys
and 20 girls aged 5 years resulting in 2 x 40 children. In comparison to the
Geiger et al study the sample will be as below.
Male 4-5 years Geiger et al n=22; current study n=40
Female 4-5 years Geiger et al n=25; current study n=40
Investigated test:
The 6 minute walk test (6MWT) will be investigated. This test is designed to
measure sub-maximal functional exercise capacity, i.e. the exercise capacity
needed in everyday life. During the 6MWT children are requested to cover a
distance of 20 meters (marked by 2 pylons) as often as possible, for a period
of six minutes. Running is not permitted. The test is self-paced. Standardised
verbal instruction and encouragement i.e. *you rare doing well, carry on* and
*one minute has passed, another five minutes to go* as specified in the
guidelines of the American Thoracic Society, will be used.
Consent:
Informed consent will be obtained from parents. Parents who give consent will
be asked to fill out a short questionnaire regarding their child*s state of
health and level of physical activity. This will take parents approximately
5-10 minutes.
Test procedure:
The test will be conducted at school, during school hours. Children will be
requested to wear light clothes and shoes or trainers. Children will be
instructed not to exercise 2 hours prior to the test. Parents will be requested
to be present during the test procedure.The child will be collected during the
PE classes by the parent. Weight will be measured with an electronic scale
(Beurer PS-16 , Beurer, Ulm Germany). Height will be measured with a
stadiometer (Seca 206, Seca , Hamburg, Germany). Heart rate and oxygen
saturation will be measured with a finger pulse oximeter (Beijing Choice
Electronic Technology Co. Ltd, Beijing, China), at the start and on completion
of the test.This is not painful or uncomfortable.
The 6 MWT will be explained an demonstrated by the investigator. The child will
then perform the 6MWT. During the test only standardised encouragements, as
described in the ATS guidelines, are given. Each minute the child will be
informed how many minutes have passed and how many minutes of the test remain.
The number of times the complete distance between the pylons is covered is
recorded. The additional distance past the last pylon is measured with a tape
measure.
Duration:
The complete testing procedure will take approximately 15 minutes per child.
Recruitment:
In order to recruit healthy Dutch children primary schools reflecting those of
the general popualtion will be contacted. The principals of the school will be
approached with a letter, followed by personal contact. If the school is
willing to participate, parents will receive a letter explaining the purpose
and procedure of the study. They will be asked to make their decision know by
filling out the consent form. The will be given 14 days to make their decision
known. Parents who give their consent will receive a short questionnaire about
their child*s state of health, his or her regular physical activities and
amount of exercise.
Study burden and risks
Benefits and burden:
The 6 minute walk test (6MWT) is a useful tool as it measures sub-maximal
functional exercise capacity, i.e. the exercise capacity needed in everyday
life to participate in physical activities with peers. At present there are no
norm values for Dutch children. Reference values from a pediatric Caucasian
cohort from Austria are used in which the test procedure was modified. New norm
values therefore need to be determined for the Dutch pediatric population.
The burden of the test is considered to be minimal. Measurement of heart rate
and oxygen saturation takes place with a finger clip and is neither painful nor
uncomfortable. The instructions of the test are easy to understand. The test is
self-paced, therefore the child determines his or her own level of exertion.
The duration of the task is short, i.e. 6 minutes. The complete test procedure
takes 15 minutes and will take place during Physcial Eexercise classes during
school hours, with one of their parents present. The activity requested for
the test also takes place in everyday life. During the test the child is
observed continually.
Dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
Dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
Listed location countries
Age
Inclusion criteria
In addition to the primary study involving children aged 6-18 we would like to include healthy Dutch children aged 4-5, with normal weight and height for age, attending regular education.
Exclusion criteria
- chronic disease or disability
- lower limb fracture or injury 1 year prior to the study
- using prescription medication
- unwell at the time of the study, i.e. running cold
- heart rate at rest when commencing the test not within norm values
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL44872.078.13 |