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.
ID
Bron
Aandoening
Juvenile Dermatomyositis.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Exercise capacity during a graded exercise test with respiratory gas analysis;<br>
2. Muscle strength as assessed with hand-held dynamometry;<br>
3. Fatigue as assessed with the PEDSQL fatigue scale.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Intervention group:
1. Measurement 1: 12 weeks training;
2. Measurement 2: 12 weeks usual care;
3. Measurement 3.
Control group:
1. Measurement 1: 12 weeks usual care;
2. Measurement 2: 12 weeks training;
3. Measurement 3: 12 weeks usual care;
4. Measurement 4.
Onderzoeksproduct en/of interventie
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.
Publiek
Wilhelmina’s Children’s Hospital/UMCU<br>
KB. 02.056.0, Lundlaan 6
M. Brussel, van
Utrecht 3584 EA
The Netherlands
+31 (0)88 75554030
m.vanbrussel@umcutrecht.nl
Wetenschappelijk
Wilhelmina’s Children’s Hospital/UMCU<br>
KB. 02.056.0, Lundlaan 6
M. Brussel, van
Utrecht 3584 EA
The Netherlands
+31 (0)88 75554030
m.vanbrussel@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL3036 |
NTR-old | NTR3184 |
Ander register | METC University Medical Center Utrecht (UMCU). : 11-336 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |