Study i)Select the most valid and feasible accelerometer for measuring habitual physical activity in children with a mitochondrial disorderStudy ii)Measure the test-retest reliability of this instrument
ID
Source
Brief title
Condition
- Inborn errors of metabolism
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study i)
The feasibility of the accelerometers during the movement-protocol in lab-gym
situation, and the validity of the different parameters calculated by the
software of the accelerometers compared to visual observations (video).
Study ii)
The validity, feasibility and test-retest reliability of the selected
accelerometer in measuring habitual physical activity of children with a
mitochondrial disorder during a longer period in the home situation
Secondary outcome
The different parameters calculated by the software of the selected
accelerometer, i.e.:
o Activity counts (counts/minute)
o Physical activity intensity (% sedentary, % light, % moderate, % vigorous)
o Steps taken (n)
o Body position (% laying, % sitting, % standing, % walking)
o Energy expenditure (MET-rates, kcal)
o Sleep-parameters (total sleep time, sleep efficiency, sleep onset latency and
wake after sleep onset)
Background summary
Children with mitochondrial disorders are physically less active and rest more
than healthy children with same age and gender. Questionnaires and endurance
tests to measure physical activity are not feasible or too burdensome due to
intellectual and physical disabilities. Accelerometry can be used to measure
habitual physical activity and has been shown to be a promising measurement
tool for future studies in children with mitochondrial disease.
Study objective
Study i)
Select the most valid and feasible accelerometer for measuring habitual
physical activity in children with a mitochondrial disorder
Study ii)
Measure the test-retest reliability of this instrument
Study design
Study i)
Five healthy children and five children with a mitochondrial disorder from
variable ages will conduct a movement-protocol while wearing three different
accelerometers at the same time. Based on the results of these
movement-protocols we will select the accelerometer that is most valid,
feasible and suitable for our research.
Study ii)
The selected accelerometer will be worn by 15 children with a mitochondrial for
7 consecutive days. As a retest one week later, the same 15 children will wear
the accelerometer for another 7 days. During another season, the 15 children
will wear the accelerometer for 7 days (test 2) and again one week later
(retest 2).
Study burden and risks
Study i)
Both healthy children and patients will come to the hospital to perform a
movement-protocol while wearing three lightweight accelerometers on their wrist
(2x) and arm (1x). The protocol will take a maximum time of 26 minutes to
perform and the children are allowed to stop if they get too tired to continue.
This study is - where possible - combined with another appointment in the
hospital for the patients.
Study ii)
During the second study, the children will wear one accelerometer during four
episodes of one week at home. During these study periods, the children are
instructed to continue with their daily life while wearing the selected
accelerometer for 24 hours per day. If the selected accelerometer is
waterproof, the children are instructed to continue wearing the device while
swimming and taking a shower. Also, they are asked to keep a diary during the
episodes, in which they have to log their experiences and daily activities. The
children might experience discomfort from wearing the device for 7 days or
dislike wearing it due to social acceptability. They are always allowed to
remove the device. Children will not be asked to come to the hospital for this
study .
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Healthy children:
o Healthy children aged 4-16 years old;Children with a mitochondrial disorder:
o Genetic mutation leading to a mitochondrial disorder
o Being capable of following instructions
Exclusion criteria
Healthy children:
o Having a known health condition that could affect the physical activity, such as Attention Deficit Hyperactivity Disorder (ADHD), for which he/she visited the general practitioner or a paediatrician.
o Visited the general practitioner or a paediatrician for tiredness in the past year;Children with a mitochondrial disorder:
o The study is estimated to be too burdensome to the patient
o Daily use of a wheelchair
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 |
|---|---|
| CCMO | NL59062.091.16 |