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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?


- candidate number4565
- NTR NumberNTR1551
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2008
- Secondary IDs08/230/K METC Utrecht
- Public TitleUtrecht 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 TitleUtrecht 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?
- ACRONYMUSAGE study
- hypothesisEarlier 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) studiedSpina bifida, Physical activity, Physical exercise, Exercise
- Inclusion criteria- Ambulatory children and adolescents with SB, type MMC or LMMC.

Inclusion criteria:
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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate1-jan-2010
- Target number of participants40
- InterventionsSupervised 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)
- TimepointsT=0 in January 2009
T=1 in March/April 2009
T=2 in June/July 2009
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. J.F. Groot, de
- CONTACT for SCIENTIFIC QUERIESMSc. J.F. Groot, de
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Bio-Kinderrevalidatie
- PublicationsN/A
- Brief summaryPurpose 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)
- RECORD20-nov-2008 - 6-dec-2008


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