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Interventieproject Osteogenesis Imperfecta (OI) type I en IV.


- candidate number1192
- NTR NumberNTR118
- ISRCTNISRCTN28577651
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR14-aug-2005
- Secondary IDs04/331-k (METC UMCU) 
- Public TitleInterventieproject Osteogenesis Imperfecta (OI) type I en IV.
- Scientific TitleHome based training program to increase exercise capacity, muscle strength and aspects of quality of life in children with Osteogenesis Imperfecta.
- ACRONYMETOI
- hypothesisChildren with Osteogenesis Imperfecta type I and IV would benefit from a gradual trainingsprogram; increased exercise capacity and muscle strength could increase quality of life.
- Healt Condition(s) or Problem(s) studiedOsteogenesis imperfecta
- Inclusion criteria1. Osteogenesis Imperfecta Type I and IV;
2. between 8 and 18 years of age;
3. ambulantory.
- Exclusion criteria1. Osteogenesis Imperfecta type II and III;
2. retardation;
3. non-walking.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-feb-2005
- planned closingdate2-aug-2005
- Target number of participants36
- InterventionsTraining program for 12 weeks (2 times/ week).
- Primary outcomeExercise capacity and muscle strength.
- Secondary outcomeHealth related quality of life.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD. PT. R.H.H. Engelbert
- CONTACT for SCIENTIFIC QUERIESPhD. PT. R.H.H. Engelbert
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Afdeling Kinderfysiotherapie
- Funding
(Source(s) of Monetary or Material Support)
Johanna Kinderfonds, Stichting Bio-Kinderrevalidatie
- Publications1. J Pediatr. 2008 Jan;152(1):111-6, 116.e1. Epub 2007 Oct 24.


2. Takken T, Terlingen HC, Helders PJ, Pruijs H, Van der Ent CK, Engelbert RH. Cardiopulmonary fitness and muscle strength in patients with osteogenesis imperfecta type I.J Pediatr. 2004 Dec;145(6):813-8.
- Brief summaryAim of this study is to investigate if children with Osteogenesis Imperfecta between 8 and 18 years of age benefit from a graded exercise program with respect to exercise capacity, muscle strength, functional outcome and quality of life. thirthy-eight children with OI type I and IV between 8 and 18 years of age will be randomly assigned in two groups (RCT). eightteen children will be treated with a graded exercise protocol, by trained paediatric physical therapists, whereas the control group will not be treated and serve as the control group.
- Main changes (audit trail)
- RECORD11-aug-2005 - 5-sep-2008


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