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ID
Source
Brief title
Health condition
Asthma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation EMG peak amplitude and lung function (FEV1)
Secondary outcome
A distinguish between healthy controls, asthma and a dysfunctional breathing pattern based upon EMG peak amplitude patterns
Background summary
Rationale: Exercise induced bronchoconstriction (EIB) is a highly specific symptom for childhood asthma. The muscular activity of the diaphragm is known to be closely related to the pulmonary function measured with spirometry. We aim to investigate the use of the non-demanding EMG measurements as an alternative measure in childhood asthma.
Objective: To determine the differences in muscular activity of the diaphragm between children with controlled asthma, uncontrolled asthma, dysfunctional breathing patterns and healthy children.
Study design: The study will have a cross sectional design, in which all children are exposed to the same exercise protocol. Asthma control will subsequently be determined by a paediatrician. Children will perform their scheduled exercise challenge test (ECT). Before the ECT protocol commences, children are equipped with a portable EMG amplifier. Before standard spirometry measurements, children are asked to sit still for 45 seconds in order to perform EMG measurements. Measurements will be repeated throughout the ECT protocol.
Study population: 120 children suspected of exercise induced dyspnea and 30 healthy children, ages 8-17.
Main study parameters/endpoints: The changes in muscular activity and spirometry will be compared to their baseline values to determine the decrease in lung function, as well as the increase in muscular activity in response to exercise. Muscular activity will also be compared to spirometry in order to establish the correlation between muscular activity and lung function changes.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this study does not pose any additional risks to participants, other than the risks involved with the scheduled ECT. For healthy subjects, there is the additional risk of falling on the treadmill. Study related patient burden is comprised of two sticky electrodes worn at the height of the diaphragm and a bracelet around one of the arms. The portable amplifier is worn on a belt. The study burden in negligible and no study related risks are present. The study must be performed in children, as exercise induced bronchoconstriction is a highly specific symptom in childhood asthma. Children may experience slight irritation of the skin due to the stick-on electrodes. We use 3M latex-free electrodes.
Study objective
We hypothesise that an increase in diaphragmatic muscle activity is coherent during bronchial constriction in children with asthma. Furthermore we hypothesise that the stretching of the lung during hyperinflation due to a dysfunctional breathing pattern will increase diaphragmatic muscle activity to maintain sufficient airflow.
Study design
A single visit to our exercise challenge lab
Intervention
Exercise challenge test
Spirometry
EMG of the diaphragm
Inclusion criteria
Ages 7-18
Referred for exercise challenge test
Respiratory symptoms
Exclusion criteria
Children/parents that do not speak Dutch
ICD/Pacemaker
Co-morbid chronic disease other than asthma
Premature birth (<37 weeks)
Psychomotor retardation
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9364 |
| CCMO | NL73398.100.20 |
| OMON | NL-OMON49352 |