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Improvement of physical endurance and motor function performance in children with anatomical congenital anomalies and/or following neonatal extracorporeal membrane oxygenation; a randomized study

Improvement of physical endurance and motor function performance in children with anatomical congenital anomalies and/or following neonatal extracorporeal membrane oxygenation; a randomized study - Improvement of physical endurance in pediatric surgical indexdiagnoses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39643
Enrollment
99
Registered
2012-02-06
Start date
2012-12-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

congenital diaphragmatic hernia esophageal atresia

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).

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in standard deviation scores on Bruce protocol 3 months after intervention.

Secondary

MeasureTime frame
-Change in standard deviation scores on Bruce protocol 12 months after intervention. -change in motor function development (total impairment score 12 months after intervention -change in concentration (Cancellation test) 3 and 12 months after start intervention -subjective report on daily physical activity 3 and 12 months after start intervention -motor competence selfreport 3 and 12 months after start intervention -quality of life judged by parents and child 3 and 12 months after start interventie -participation 12 months after start intervention -pro-active coping behaviour of parents 3 and 12 months after start intervention -evaluation of cost effectiveness

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)