|- candidate number||10644|
|- NTR Number||NTR3184|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2011|
|- Secondary IDs||11-336 METC University Medical Center Utrecht (UMCU).|
|- Public Title||Physical training for children and adolescents with Juvenile Dermatomyositis.|
|- Scientific Title||Muscles in Motion: Exercise rehabilitation for children and adolescents with Juvenile Dermatomyositis.|
|- hypothesis||An individual tailored 12 weeks home-based exercise training program will increase the physical fitness, muscle strength, and quality of life, and will reduce levels of fatigue of patients with Juvenile Dermatomyositis.
|- Healt Condition(s) or Problem(s) studied||Juvenile Dermatomyositis|
|- Inclusion criteria||1. Diagnosed Juvenile Dermatomyositis by a pediatric rheumatologist using the Bohan and Peter criteria;|
2. Be able to follow instructions regarding testing and training;
3. Parental and child informed consent;
4. Age between 8-18 years of age.
|- Exclusion criteria||1. Insufficient understanding of the Dutch language in both children and parents;|
2. Medical events that might intervene with the outcome of testing;
3. Medical status that will not allow maximal exercise testing (e.g. acute fever, heart conditions).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-jan-2014|
|- Target number of participants||30|
|- Interventions||Treadmill training and strength training, minimal twice a week at home (30-60 minutes per session), for 12 weeks. The control group also enters the training arm directly after completing the initial protocol.|
|- Primary outcome||1. Exercise capacity during a graded exercise test with respiratory gas analysis;|
2. Muscle strength as assessed with hand-held dynamometry;
3. Fatigue as assessed with the PEDSQL fatigue scale.
|- Secondary outcome||1. Muscle soreness as assessed with the 10 cm Visual Analogue Scale;|
2. Muscle function as assessed with the Childhood Myositis Assessment Scale (CMAS);
3. Walking distance at the 6-minutes walking test;
4. Quality of life as assessed with the PEDSQL questionnaire;
5. Functional ability as assessed with the Childhood Health Assessment Questionnaire;
6. Physical activity as assessed by 7 days activity monitoring using an Actical accelerometer;
7. Physical activity enjoyment as assessed with the Physical Activity Enjoyment Scale.
|- Timepoints||Intervention group: |
1. Measurement 1: 12 weeks training;
2. Measurement 2: 12 weeks usual care;
3. Measurement 3.
1. Measurement 1: 12 weeks usual care;
2. Measurement 2: 12 weeks training;
3. Measurement 3: 12 weeks usual care;
4. Measurement 4.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Brussel, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Brussel, van|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Aim of this intervention study is to determine the effects of an individual tailored 12 weeks home-based exercise program on the aerobic fitness and muscle strength of patients with Juvenile Dermatomyositis. Furthermore, the wash-out effects of the intervention program after another 12 weeks will be determined. Thirty children with Juvenile Dermatomyositis between 8 and 18 years will be randomly assigned in two groups (RCT). Children allocated to the intervention group will receive the exercise program. Children in the control group will only receive usual care during these 12 weeks, hereafter they also will receive the exercise program.|
|- Main changes (audit trail)|
|- RECORD||7-dec-2011 - 17-dec-2011|