To investigate whether children with OI who use a wheelchair (for long distances) can reliably perform a valid shuttle ride test in order to assess the levels of health-related fitness in this group.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reliability (test re-test reliability/reproducibility) of the shuttle ride test
;
Validity of the shuttle ride test (attained peak heart rate and peak
respiratory exchange ratio);
Maximal oxygen consumption (VO2peak) attained during the shuttle ride test
(health-related fitness);
Rating of perceived exertion directly after the shuttle ride test.
Secondary outcome
Muscle force (grip strength and one-stroke push test);
Fatigue (18-item PedsQL multidimensional fatigue scale);
Activities in daily life (wearing an accelerometer for one week).
Background summary
Children and adolescents with osteogenesis imperfecta (OI) have lost a
considerable part of the functioning of their body and for most of them it is
difficult to participate in physical activities or sport programs as a
consequence of real or perceived limitations imposed by their condition. The
condition itself often causes hypoactivity, which leads to a deconditioning
effect, a reduction in the functional ability and further hypoactivity. These
poor fitness-levels compared to healthy peers have been well-documented by
means of exercise tests in children and adolescents with OI who are able to
walk independently. Moreover, exercise testing has been used as a primary
outcome measure of therapy and exercise program in children with OI. However,
for children and adolescents with OI who use wheelchairs the fitness levels are
still unknown.
Study objective
To investigate whether children with OI who use a wheelchair (for long
distances) can reliably perform a valid shuttle ride test in order to assess
the levels of health-related fitness in this group.
Study design
Feasibility and reliability study (observational, non-invasive)
Study burden and risks
The participants will be asked to perform a shuttle ride test including
respiratory gas analysis until voluntary exhaustion on two occasions. In
general, performing a maximal CPET is safe for children and adolescents, even
for those with diagnoses placing them in a high-risk group. A study of Alpert
et al. (1983) evaluated the frequency of significant complications of exercise
testing in 1,730 children and found an overall incidence of complications of
1.79%. The authors concluded that exercise testing in children has low
morbidity and mortality. Moreover, the study of van Brussel et al. (2008)
reported no adverse health or safety effects in children and adolescents with
OI (type I and IV) who are able to walk and completed a maximal CPET on a cycle
ergometer. The risks for bone fractures during the shuttle ride test as well as
during the assessment of muscle strength will not be increased because of the
dynamic nature of the movement and the low peak power during dynamic exercise.
Since the *make* method will be used during the grip strength measurements, the
participants will determine the self-generated muscle force, reducing the risks
for complications. The same holds true for the 1SPT. The demographic,
anthropometric, and accelerometry measurements do not include risks either.
Lundlaan 6
Utrecht 3584 AB
NL
Lundlaan 6
Utrecht 3584 AB
NL
Listed location countries
Age
Inclusion criteria
Wheelchair-bound patients with OI:
* Boys and girls aged 8 to 25 years,will be enrolled;
* Diagnosis of OI and using a wheelchair (for long distances);
* Modified Bleck score * Treated at the the ORSK consulting-hour, UMC Utrecht or Isala Klinieken;
* Sufficiently healthy to participate.;Healthy peers:
* Age- and gender-matched healthy peers will be enrolled;
* Prepubescent, pubescent, and postpubescent children.
Exclusion criteria
Wheelchair-bound patients with OI:
* A medical status that contraindicates exercise (e.g. cardiomyopathy);
* The use of medication affecting exercise capacity;
* Unable to cooperate with the testing procedures (e.g. insufficient understanding of the Dutch language).;Healthy peers:
* A medical status that contraindicates exercise;
* The use of medication affecting exercise capacity;
* Cardiovascular or respiratory disease;
* Impaired motor development;
* Morbid obesity (body mass index (BMI) >35 kg/m2);
* Unable to cooperate with the testing procedures (e.g. insufficient understanding of the Dutch language).
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 | NL41053.041.12 |