search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Fitkids, a nationwide exercise therapy program in the Netherlands: is it effective?


- candidate number10499
- NTR NumberNTR3133
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2011
- Secondary IDs11-325/C METC UMC Utrecht
- Public TitleFitkids, a nationwide exercise therapy program in the Netherlands: is it effective?
- Scientific TitleInsight in the effects of the exercise therapy program ‘Fitkids’ on physical fitness, muscle strength and health-related quality of life in children with chronic conditions or disabilities.
- ACRONYM
- hypothesisThe exercise therapy program ‘Fitkids’ is effective to increase physical fitness, muscle strength and health-related quality of life in children with chronic conditions or disabilities.
- Healt Condition(s) or Problem(s) studiedChronic disorder, Exercises, Children, Exercise therapy, Pediatric physical therapist, Disabilities
- Inclusion criteriaChildren between 6-18 yrs of age with a chronic disease or disability who are inactive.
- Exclusion criteria1. No informed consent given;
2. Incapable of understanding Dutch;
3. Inability to exercise;
4. Inability to walk.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2011
- planned closingdate1-okt-2012
- Target number of participants100
- InterventionsThe exercise training (60 minutes) includes a warming up based on simple competitive and/ or strategic games. Further, the program is performed individually. For this, treadmills, cross trainers, stationary exercise bikes, rowing machines and other indoor exercise equipment are used. The intensity of the program is 2×/ week one hour in the first 3 months and one hour in month 4-6.
- Primary outcomePre program and post program levels of aerobic fitness, muscle strength and levels of health-related quality of life.
- Secondary outcomePre program and post program levels of daily activity.
- TimepointsBaseline and after 3 and 6 months of intervention.

1. Levels of physical fitness: Assessed by Six Minute Walk Test (6MWT); Muscle Power Sprint Test (MPST); Modified Bruce Treadmill Test;
2. Muscle Strength: Assessed by the Strength and Agility Scale of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2);
3. Health related Quality of Life: Assessed by DUX-25;
4. Daily activity: Assessed by means of a Dutch questionnaire, developed by the Local and National Youth Health Monitor.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Elles Kotte
- CONTACT for SCIENTIFIC QUERIESMSc. Elles Kotte
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ), Child Development & Exercise Center , Fitkids Foundation
- PublicationsNone
- Brief summaryBackground:
Regular aerobic physical activity is important for healthy children as well as children with a chronic condition. Impaired physical fitness have been reported in all kinds of chronic conditions in children, which is related to restrictions in sports participation because of their physical functioning. However it seems also related to a sedentary lifestyle and limited access to nearby facilities and training programs for these children. Based on these experiences, we developed an exercise therapy program (Fitkids) for children with a chronic condition or disability which can be seen as a facilitator for an active lifestyle.

Objective of the study:
To determine the effect of the exercise therapy program ‘Fitkids’ on physical fitness, muscle strength and health-related quality of life in children with chronic conditions or disabilities.

Study design:
A 6 months exercise therapy program will be evaluated, The intensity of the program is 2×/week one hour in the first 3 months and one hour/week in month 4-6. The evaluation of the program is based on exercise testing and investigating the health-related quality of life immediately after the training period and this will be compared with baseline levels that has been measured at the start of the program and levels after 3 months of training.

Study population:
One-hundred children between 6-18 yrs of age with a chronic condition or disability.

Intervention:
The exercise training (60 minutes) includes a warming up based on simple competitive and/ or strategic games. Further, the program is performed individually. For this, treadmills, cross trainers, stationary exercise bikes, rowing machines and other indoor exercise equipment are used. The intensity of the program is 2×/week one hour in the first 3 months and one hour/week in month 4-6.

Primary study parameters/ outcome of the study:
Pre program and post program levels of aerobic fitness, muscle strength and levels of health-related quality of life.

Secondary study parameters/ outcome of the study:
Pre program and post program levels of daily activity.
- Main changes (audit trail)
- RECORD3-nov-2011 - 26-nov-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl