|- candidate number||14007|
|- NTR Number||NTR3729|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-nov-2012|
|- Secondary IDs||2011-475 / 2011/0128; METC / KFA|
|- Public Title||Improvement of fitness and motor function in children with congenital anomalies.|
|- Scientific Title||Improvement of maximal exercise capacity and motor function in children with anatomical congenital anomalies and/or following neonatal ECMO treatment.|
|- ACRONYM||Beweeg met plezier|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Congenital diaphragmatic hernia, Motor development, ECMO, Family coaching, Oesophageal atresia, Maximal exercise capacity, Exercise training program|
|- 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);
3. Medical contraindication to perform maximal exercise test;
4. Insufficient command of Dutch language (child or parents) to understand online coaching program.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2012|
|- planned closingdate||1-dec-2015|
|- Target number of participants||99|
|- Interventions||Group A: Lifestyle-coaching for child and itís family;|
Group B: Lifestyle-coaching for child and itís 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 the parents. A senior physical therapist performs the coaching by establishing a main goal and weekly goals that should be achieved by the child. Duration 13 weeks intensively, followed by 13 weeks less intense if needed.
Exercise-training is performed by a pediatric physical therapist living close to the families' home. The training program is protocollized and will be performed twice a week during 13 weeks.
For standard of care a brochure from our department of pediatric physical therapy will be handed out to the families. This brochure explains how more exercise aiming at improvement of physical endurance can be achieved.
|- Primary outcome||Change in standard deviation scores on Bruce protocol 3 and 12 months after intervention.|
|- Secondary outcome||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.
|- Timepoints||3 and 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD. Monique H.M. Cammen - van Zijp, van der|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Hanneke IJsselstijn|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Kinderrevalidatiefonds de Adriaanstichting, Erasmus Medical Center, Department of Pediatric Surgery, Swart van Essen Fonds|
|- Brief summary||Rationale: |
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.
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.
Single blind, randomized intervention study.
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.
Group A: lifestyle-coaching for child and itís family;
Group B: lifestyle-coaching for child and itís 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).
Main study parameters/endpoints:
Change in standard deviation scores on Bruce protocol 3 and 12 months after intervention.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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), flow-volume lung function (once; 30 min). Additionally, an activity monitor is to be worn at home during 7 consecutive days and nights (taken off during shower, swimming classes etc.); 3 times (at start and after 3 and 12 months). This activity monitor is small and wonít interfere with regular daily activities.
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.
|- Main changes (audit trail)|
|- RECORD||19-nov-2012 - 16-dec-2012|