Improvement of fitness and motor function in children with congenital anomalies.

Improvement of maximal exercise capacity and motor function in children with anatomical congenital anomalies and/or following neonatal ECMO treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25080

Enrollment

Registered

2012-11-19

Start date

2012-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital anatomical anomalies neonatal ECMO treatment maximal exercise capacity lifestyle coaching exercise training program congenitale hernia diafragmatica oesofagusatresie ECMO aangeboren kinderchirurgische aandoeningen duuruithoudingsvermogen' motorische ontwikkeling coaching voor het gezin conditietraining

Interventions

Group A: Lifestyle-coaching for child and it’s family

Group B: Lifestyle-coaching for child and it’s family and exercise-training for the child twice a week during 13 weeks

Group C: Standard of care, i.e. advise on physical activity (once at outpatient clinic). Life-style coaching is provided using an online customized program with a page for the child and a page for th

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. (Severely) delayed motor function (i.e. percentilescore < 6 at M-ABC); 2. Inability to perform maximal exercise test (Bruce protocol); 3. Medical contraindication to perform maximal exercise test; 4. Insufficient command of Dutch language (child or parents) to understand online coaching program.

Design outcomes

Primary

Measure	Time frame
Change in standard deviation scores on Bruce protocol 3 and 12 months after intervention.	—

Secondary

Measure	Time frame
1. Total impairment score M-ABC test at 12 months; 2. Daily activity monitored at 3 and 12 months; 3. Questionnaire on daily activity at 3 and 12 months; 4. Quality of life at 3 and 12 months; 5. Participation at 3 and 12 months; 6. Proactive coping competence of parents at 3 and 12 months; 7. Cost effectiveness.	—

Contacts

Public ContactMonique H.M. Cammen - van Zijp, van der

Dept of Rehabilitation and Physical Therapy Sophia Children's Hospital Dr Molewaterplein 60

bewegen.chil@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)