|- candidate number||4565|
|- NTR Number||NTR1551|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-nov-2008|
|- Secondary IDs||08/230/K METC Utrecht |
|- Public Title||Utrecht Spina Bifida And Graded Exercise (USAGE) Study part 2: Does training in ambulatory children with SB increase levels of physical fitness, energy cost of locomotion and daily physical activity?|
|- Scientific Title||Utrecht Spina Bifida And Graded Exercise (USAGE) Study part 2: Does training in ambulatory children with SB improve levels of physical fitness, energy cost of locomotion and daily physical activity?|
|- ACRONYM||USAGE study|
|- hypothesis||Earlier studies have shown lower levels of physical acitivity, physical fitness and high energy cost of locomotion in children with Spina Bifida (SB) . Our hypothesis is that training can improve both physical fitness and energy cost of locomotion in children with SB.|
|- Healt Condition(s) or Problem(s) studied||Spina bifida, Physical activity, Physical exercise, Exercise|
|- Inclusion criteria||- Ambulatory children and adolescents with SB, type MMC or LMMC. |
1. At least community ambulatory (be able to ambulate >100 meters outside the home)
2. Be able to follow instructions regarding testing and training.
3. Parental and child informed consent.
4. Age 6-18 years of age.
|- Exclusion criteria||1. Insufficient understanding of the Dutch language in both children and parents.|
2. Medical events that will not allow exercise testing and/or training.
3. Children participating in high level sports and/or more than 3 hours a week.
4. Severe cognitive impairments (IQ<80)
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2009|
|- planned closingdate||1-jan-2010|
|- Target number of participants||40|
|- Interventions||Supervised treadmill training, twice a week at home, for twelve weeks.
|- Primary outcome||- Physical fitness (VO2peak and strength) |
- Energy cost of locomotion
- Distance walked during six-minute walk test
|- Secondary outcome||- Physical activity level (PAL)|
- Daily fatigue (PedsQL)
|- Timepoints||T=0 in January 2009|
T=1 in March/April 2009
T=2 in June/July 2009
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. J.F. Groot, de|
|- CONTACT for SCIENTIFIC QUERIES||MSc. J.F. Groot, de|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Purpose of this intervention study is to determine the effects of an exercise program on physical fitness and energy cost of locomotion in children and adolescents with Spina Bifida|
|- Main changes (audit trail)|
|- RECORD||20-nov-2008 - 6-dec-2008|