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Het effect van een inspanningstest bij jonge kinderen met astma op de therapietrouw van medicijnengebruik en ziekte inzicht bij ouders.


- candidate number12375
- NTR NumberNTR3432
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mei-2012
- Secondary IDsNL40615.044.12 CCMO
- Public TitleHet effect van een inspanningstest bij jonge kinderen met astma op de therapietrouw van medicijnengebruik en ziekte inzicht bij ouders.
- Scientific TitleThe IMPact of an exercise challenge test in young Asthmatic Children on adherence and parental illness percepTions.
- ACRONYMIMPACT
- hypothesisAn ECT will lead to better adherence and illness and medication perceptions in young children with asthma.
- Healt Condition(s) or Problem(s) studiedAsthma, Children, Exercise induced Asthma
- Inclusion criteria1. Clinical history of asthma symptoms;
2. Age 5 through 7 years;
3. Use of maintenance corticosteroids/combination medication;
4. Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
- Exclusion criteria1. Exacerbation in the last 4 weeks prior to the ECT (hospital admission or use of systemic corticosteroids);
2. Use of long acting bronchodilators 24 hours before testing;
3. Use of short acting bronchodilators 8 hours before testing;
4. Use of leukotriene antagonists 24 hours before testing;
5. Other pulmonary or cardiac disorder;
6. History of ECT;
7. Severe EIB; Fall of FEV1 (or FEV0.5) > 50% at ECT requiring medication change.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-mei-2012
- Target number of participants90
- InterventionsExercise challenge test on jumping castle.
- Primary outcomeAdherence to medication.
- Secondary outcomeIllness and medication perceptions.
- TimepointsTime =0: Questionnaires for parens, electronic logger for medication;
Time = 1 month: Exercise challenge test, reading out the electronic logger and questionnaires for parens immediately after exercise test;
Time = 2 months: Reading out the electronic logger and get rid of it and questionnaires for parents.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. B.J. Thio
- CONTACT for SCIENTIFIC QUERIESDr. B.J. Thio
- Sponsor/Initiator Stichting Pediatric Research Enschede
- Funding
(Source(s) of Monetary or Material Support)
Stichting Pediatric Research Enschede
- PublicationsN/A
- Brief summaryExercise induced bronchoconstriction (EIB) is a highly specific symptom of asthma in young children. EIB is a frequent complaint and also the most bothersome for this group of patients. Exercise challenge tests (ECT) can identify EIB and are therefore frequently used to diagnose asthma and evaluate asthma treatment. Several studies have shown that interventions with reviewed tests results can modify compliance to medical treatment or lifestyle regimens, which is in line with our clinical experience from previous exercise tests. The aim of this study is to analyse the influence of an ECT in young children with asthma on adherence to maintenance medication.
- Main changes (audit trail)
- RECORD14-mei-2012 - 11-aug-2012


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