Improvement of fitness and motor function in children with congenital anomalies.
Completed
- Conditions
- congenital anatomical anomaliesneonatal ECMO treatmentmaximal exercise capacitylifestyle coachingexercise training programcongenitale hernia diafragmaticaoesofagusatresieECMOaangeboren kinderchirurgische aandoeningenduuruithoudingsvermogen'motorische ontwikkelingcoaching voor het gezinconditietraining
- Registration Number
- NL-OMON25080
- Lead Sponsor
- Erasmus MC - Sophia Children's Hospital
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
Inclusion Criteria
Children born between 2000 and 2006 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
1. (Severely) delayed motor function (i.e. percentilescore < 6 at M-ABC);
2. Inability to perform maximal exercise test (Bruce protocol);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in standard deviation scores on Bruce protocol 3 and 12 months after intervention.
- Secondary Outcome Measures
Name Time Method 1. Total impairment score M-ABC test at 12 months;<br /><br>2. Daily activity monitored at 3 and 12 months;<br /><br>3. Questionnaire on daily activity at 3 and 12 months;<br /><br>4. Quality of life at 3 and 12 months;<br /><br>5. Participation at 3 and 12 months;<br /><br>6. Proactive coping competence of parents at 3 and 12 months;<br /><br>7. Cost effectiveness.