Improvement of physical endurance and motor function performance in children with anatomical congenital anomalies and/or following neonatal extracorporeal membrane oxygenation; a randomized study
Completed
- Conditions
- congenital diaphragmatic herniaesophageal atresia1003868610028971
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
Inclusion Criteria
Children born between 2000 and 2007 with congenital diaphragmatic hernia, esophageal atresia, giant omphalocele and those who have been treated with ECMO in the neonatal period. Inclusion if standard deviation score on the maximal exercise test (Bruce protocol) is < -1.
Exclusion Criteria
- delayed motor function development and need for intervention by a pediatric physical therapist
- inability to perform proper exercise test
- medical contraindication to perform maximal endurance exercise test
- insufficient command of Dutch language to understand instructions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in standard deviation scores on Bruce protocol 3 months after<br /><br>intervention.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Change in standard deviation scores on Bruce protocol 12 months after<br /><br>intervention.<br /><br>-change in motor function development (total impairment score 12 months after<br /><br>intervention<br /><br>-change in concentration (Cancellation test) 3 and 12 months after start<br /><br>intervention<br /><br>-subjective report on daily physical activity 3 and 12 months after start<br /><br>intervention<br /><br>-motor competence selfreport 3 and 12 months after start intervention<br /><br>-quality of life judged by parents and child 3 and 12 months after start<br /><br>interventie<br /><br>-participation 12 months after start intervention<br /><br>-pro-active coping behaviour of parents 3 and 12 months after start intervention<br /><br>-evaluation of cost effectiveness</p><br>