1. To detrrmine the applicability of standard energy expenditure prediction equations for accelerometry in measuring physical activity in children with musculoskeletal and other chronic diseases (see below).2. To develop disease specific prediction…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Joint disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the agreement between predicted energy expenditure
from accelerometry counts compared to directly measured energy expenditure via
metabolic cart.
Secondary outcome
We will begin to develop disease specific prediction equations - where
necessary - to determine the relationship between accelerometry counts and
energy expenditure in these groups.
We will compare 2 different accelerometers (Actical with Actigraph) to
determine if one is superior in predicting energy expenditure compared to the
other.
Background summary
This pilot study will provide tools with which to better study the interaction
between physical activity and musculoskeletal disease in children. Habitual
physical activity may play an important role in the prevention or attenuation
of chronic disease. Assessment of physical activity can be used to determine
disease specific rehabilitation programs and to measure outcomes in research
interventions. Accelerometry, a measure of physical activity, has been shown to
be valid and reliable way to characterize physical activity patterns in healthy
children but may not be valid in chronic disease. The applicability of
accelerometry must be determined in children with chronic disease.
Study objective
1. To detrrmine the applicability of standard energy expenditure prediction
equations for accelerometry in measuring physical activity in children with
musculoskeletal and other chronic diseases (see below).
2. To develop disease specific prediction equations - where necessary - to
determine the relationship between accelerometry counts and energy expenditure
for each of these groups of children.
3. To compare the applicability of unidirectional (vertical) and
omni-directional (all directions) accelerometers in predicting energy
expenditure.
Study design
This is an observational study in which children will participate in a single
exercise testing session at SickKids or UMC. Energy expenditure measured via
expired gas using a metabolic cart and accelerometry counts will be determined
for each subject while completing two exercise protocols. Exercise protocol:
Children will participate in two treadmill walking tasks followed by a jogging
task at a self-selected pace. Activities of daily living protocol: Each
participant will engage in 7 minutes each of playing video games while seated,
a cleaning task (sweeping), two jumping tasks, and a stair-stepping routine.
These protocols represent the spectrum of intensity range of activities that a
child might engage in during a typical day. Other measures include heart-rate
monitoring, self-report physical function and health-related quality of life
and assessments of pain using 10cm visual analog scales.
Study burden and risks
Participants will be asked to take part in one exercise testing session that
will last approximately 2.5 hours. They will be asked to participate in several
exercise tasks, several daily living tasks, and will be asked to fill in 4
questionnaires. The level of discomfort should be minimal as all of these tasks
are safe for children to perform. They may experience some muscle soreness or
stiffness, but this should not worsen their disease or disability.
postbus 85090
3508 AB
Nederland
postbus 85090
3508 AB
Nederland
Listed location countries
Age
Inclusion criteria
Age 8 to 18 years.
Both prepubescent and pubescent children will be enrolled.
• Healthy controls - will include any child without a history of disease or disability who are able to cooperate with the testing procedures.
• Diagnosis of Juvenile Idiopathic Arthritis (JIA) - based on the ILAR criteria (56) OR
• Diagnosis of Severe Hemophilia A or B (< 1% clotting factor activity) OR
• Diagnosis of Juvenile Dermatomyositis (JDM) - based on the Bohan & Peter criteria OR
• Diagnosis of dystrophinopathy (Beckers, Duchenne*s) or other inherited muscle disease OR
• Diagnosis of Cerebral Palsy (Gross Motor Function Classification system Levels I or II) (57) OR
• Diagnosis of Cystic Fibrosis OR
• Diagnosis of congenital heart disease (CHD) and Fontan procedure or tetralogy of Fallot repair.
Exclusion criteria
Medical status that will not allow exercise testing
Medications that interfere with heart rate response to exercise
Non-ambulation: patients who are unable to ambulate
Insufficient understanding of the Dutch language in both children and parents
See also page 14 of the protocol
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 | NL18035.041.07 |