In this study, we aim to test the feasibilty, reliability and validity of the MOX-accelerometer in measuring daily physical activity in children with mitochondrial disease.
ID
Source
Brief title
Condition
- Metabolic and nutritional disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility (% of patients), reliability (test-retest, % of data) and
validity (correlation with video of standardized movements, correlation with
reported activities) of the MOX-accelerometer in children with a mitochondrial
disease
Secondary outcome
na
Background summary
More and more clinical studies are performed in patients with mitochondrial
disorders, of which many in children. Children with mitochondrial disorders are
often severely disabled and not able to follow commands. One of the major
complaints of this patient group, is lack of energy and tiredness.
Study objective
In this study, we aim to test the feasibilty, reliability and validity of the
MOX-accelerometer in measuring daily physical activity in children with
mitochondrial disease.
Study design
Patients are asked to wear the accelerometer for two consequetive weekend days.
The validity is tested by using a standardized protocol of movements and by
correlating with the sort and intensity of activities, as reported by parents.
Parents are asked to fill out a diary during the weekend, reporting the sort of
activity, and the subjective activity and wellbeing of the patient.
We will include both patients and healthy controls to be able to express the
activity as a percentage of the healthy population.
Study burden and risks
In our previous study in patients with Leigh syndrome, no complications of
wearing the MOX-accelerometer were reported. We cannot think of risks of
wearing the accelerometers other than decubitus (which will always be limited
since the meters are worn only for one weekend and they should be removed in
case any redness of the skin appears). The burden is mainly an administrative
burden to parents.
For the group of children with mitochondrial disease as a whole, and maybe even
for other diseases with severe disabilities, this is a valuable study in
chosing outcome measures for future clinical trials based on experience.
Geert grooteplein noord 10
Nijmegen 6500 HB
NL
Geert grooteplein noord 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Patients:
- aged 4-18 years
- decreased ATP production in fresh muscle (to same extend as descrease in pyruvateoxidation rate) or mutation in gene known to cause mitochondrial disease
- follow-up in NCMD;Heatlhy controls
- Healthy
- Regular education
- Aged 4-18 years
Exclusion criteria
Patients:
- Fever
- Epilepsia continua
- Altered state of conciousness compared to normal;Healthy controls:
- Regularly seen by a paediatrician
- Complaints of exercise intolerance, muscle complaints or fatigue, more than peers
- Official ADHD diagnosis
- Sibling with neuromuscular or metabolic disease
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 | NL50560.091.14 |