The main objective is to improve exercise tolerance. Secondary objectives are: 1) improvement of motor function development, daily physical activity, quality of life, self perception of motor competence, and participation; 2) evaluation of cost…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in standard deviation scores on Bruce protocol 3 months after
intervention.
Secondary outcome
-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
Background summary
Children with congenital anatomical anomalies and those treated with neonatal
ECMO are at risk for decreased exercise tolerance. Early intervention by
offering life-style coaching to the child and its family may be beneficial.
Addition of an exercise-training program to this intervention may result in
further improvement of exercise tolerance. Physical exercise has beneficial
effects on concentration in children.
Study objective
The main objective is to improve exercise tolerance. Secondary objectives are:
1) improvement of motor function development, daily physical activity, quality
of life, self perception of motor competence, and participation; 2) evaluation
of cost effectiveness, 3) evaluation of concentration.
Study design
Single blind, randomized intervention study
Intervention
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).
Study burden and risks
The burden includes 3 extra hospital visits within 12 months (duration maximal
3 hours, excluding travel time) including a maximal exercise test (each visit;
20 min), evaluation of motor function development (twice: 1 hour) and
questionnaires (each visit, approximately 1 hour), concentration task
(Cancellation test; 20 min; each visit), flow-volume lung function (once; 30
min).
In Group A and Group B: lifestyle-coaching and change of lifestyle (more
physical activity) costs time at home. In Group B extra burden is: exercise
training twice a week during 13 weeks (1 hour; excluding travel time). Risks
are not more than expected from regular physical activity at home. Benefits are
improvement of exercise tolerance and motor function. From this group of
patients we know that they are at risk for decreased exercise tolerance that
may deteriorate over time. Therefore, this group may benefit from the
intervention.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38684.078.11 |