The aim of this study is to investigate the course of EIB in young asthmatic children, by using a newly designed exercise provocation challenge.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main objective of this study is the measurement of pulmonary function (change
in FEV1, FEV0.5 and FEF50) during and post-exercise in young children with
asthmatic features. Thus the percent change in pulmonary function (FEV1, FEV0.5
and FEF50) during and post-exercise.
Secondary outcome
Secondary objectives are:
-analysis of anthropometric measures, clinical features, medication use and
history (measured by extensive history) of children with a positive or negative
exercise provocation challenge.
-analysis of the feasibility of a newly designed exercise provocation challenge
using a jumping castle.
Background summary
Exercise induced bronchoconstriction (EIB) is highly specific for asthma and
exercise provocation challenges are therefore frequently used to diagnose
asthma and evaluate asthma treatment. There seems to be an important relation
between age and the clinical course of EIB; the younger the child, the shorter
the time to maximal bronchoconstriction following exercise and the quicker the
recovery from EIB. Moreover, in many asthmatic children EIB starts during, and
not after, exercise. Little is known about the clinical course of EIB in young
children (<8 years).
Study objective
The aim of this study is to investigate the course of EIB in young asthmatic
children, by using a newly designed exercise provocation challenge.
Study design
This study is of a cross-sectional, single occasion observational design.
Patients will undergo an extensive evaluation of their asthma, including a
history, physical examination and a newly designed exercise provocation
challenge. This exercise provocation challenge exists of jumping on a jumping
castle for at least 4 minutes (target is a 6 minute lasting exercise at 80% of
the predicted maximum heart rate). Before, during and after exercise, patients
perform pulmonary function measurements (flow volume curves).
Intervention
No intervention, other than the exercise provocation challenge, will be
investigated. An exercise provocation challenge is part of the routine clinical
evaluation of patients with exercise induced symptoms or asthma. However, an
exercise provocation challenge in the evaluation of asthmatic children aged 5
till 7 years isn*t widely used and can therefore be seen as an intervention.
Moreover, our newly designed exercise provocation challenge, using a jumping
castle is experimental.
Thus the intervention used in our study is a newly designed exercise
provocation challenge. This exercise provocation challenge exists of jumping on
a jumping castle for at least 4 minutes (target is a 6 minute lasting exercise
at 80% of the predicted maximum heart rate). Before, during and after exercise,
patients perform pulmonary function measurements (flow volume curves).
Study burden and risks
The risks of participation are considered minimal.
Patients have to undergo one exercise provocation challenge with the chance of
getting dyspnoeic. Especially in children, exercise limitation is a heavy
burden on the quality of life, however the exercise challenges poses a minimal
risk. The possible dyspnoea is comparable to that experienced when exercising
in real life and children generally consider this as a minimal burden.
With the development of the design of our exercise provocation challenge, the
age of the children is taken into consideration. We tried to minimize the
burden of exercise by using a jumping castle.
Haaksbergerstraat 55
7513 ER Enschede
NL
Haaksbergerstraat 55
7513 ER Enschede
NL
Listed location countries
Age
Inclusion criteria
- Clinical history of asthma symptoms.
- Age 5-7 years.
- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
- Clinically stable period at least 4 weeks before the study period (no hospital admission or
use of systemic corticosteroids).
Exclusion criteria
- Use of systemic corticosteroids in the last 4 weeks prior to the study.
- Use of long acting bronchodilators 24 hours before testing.
- Use of short acting bronchodilators 8 hours before testing.
- Use of leukotriene antagonists 24 hours before testing.
- Other pulmonary or cardiac disorder.
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 | NL38021.044.11 |
| Other | NTR-volgt |