|- candidate number||27770|
|- NTR Number||NTR6658|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-aug-2017|
|- Secondary IDs||NL 62436.018.17 / W17-179 ToetsingOnline / METC nummer|
|- Public Title||SIMBA: Stimulating physical activity in children with asthma by an exercise game|
|- Scientific Title||SIMBA: Stimulating physical activity in children with asthma|
|- hypothesis||There are factors that restrict and promote exercise behavior in children with asthma. An new developed exercise game including tools to overcome these factors will be stimulating in physical activity and can stimulate exercise behavior.|
|- Healt Condition(s) or Problem(s) studied||Asthma, Children, Physical activity, Health games|
|- Inclusion criteria||1) Children aged eight to twelve, with a medically confirmed diagnosis of asthma. Children are in a patient database in one of the three participating hospitals. They may be, but not necessarily are, under active medical control or guidance in one of the three participating hospitals. |
2) Parents or legal guardians of children with asthma aged 8-12 years old.
3) Healthcare professionals who have experience in treating children with asthma.
|- Exclusion criteria||Exclusion criteria|
1) Children with another (chronic) disease, or mental/ physical co-morbidity that reduces the ability to be physically active. Children who do not understand, speak, read and write the Dutch language.
2) Parents or legal guardians of a child meeting the study inclusion criteria who do not understand, speak, read or write the Dutch language.
3) Healthcare professionals who do not have any experience in treating children with asthma.
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2017|
|- planned closingdate||1-jul-2018|
|- Target number of participants||36|
|- Interventions||Phase 1. Exploring thoughts, perceptions and experiences with physical activity and exercise in children with asthma, parents and healthcare professionals who work with children with asthma. |
Phase 2. Developing an exercise game for children with asthma in co-creation with the children, their parents and healthcare professionals.
|- Primary outcome||At the end of the study we have a prototype of an exercise game for children with asthma including exercise stimulating factors.|
|- Secondary outcome||Ideas, thoughts, perceptions and experiences in relation to physical activity stimulation and children with asthma.|
|- Timepoints||Phase 1: one assessment based on the concept mapping procedure|
Phase 2: two soundboardgroup meetings
|- Trial web site||www.simba-onderzoek.nl|
|- CONTACT FOR PUBLIC QUERIES|| Katja I. Braam|
|- CONTACT for SCIENTIFIC QUERIES|| Katja I. Braam|
|- Sponsor/Initiator ||Faculty of Health, University of Applied Science, Amsterdam, Academic Medical Center (AMC), Department of Pediatric Pulmonology |
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: In the Netherlands approximately 7-10% of all children live with asthma. Exercise may help to improve physical functioning (physical fitness) and may increase asthma control. It is known that physical activity of children with asthma is influenced by many factors. Enjoying the performance of physical activity may be one of them. On the other hand factors such as fear and shame hinder them being physically active. It is important to improve physical functioning by using life style interventions (coping and behavior).The use of gaming seems to be an effective method of stimulating daily physical activity on the long-term which also match the needs of children of the 21st century.|
Objective: To assess factors that restrict and promote exercise behavior in children with asthma and using this knowledge to identify the ingredients for developing an exercise game which is best suited to the needs of children with asthma and can stimulate exercise behavior.
Study design: A cross-sectional observational study.
Study population: Children with mild, moderate or severe asthma, aged eight to twelve years old, without co-morbidity influencing cognitive- or physical functioning. In addition, parents of these children and healthcare professionals (physical therapists) who support these children will participate in present study.
During the first phase factors that restrict and promote exercise behavior are gathered through a concept mapping procedure.
The second phase includes two sound board group meetings to provide feedback on the prototypes of the exercise games. The most prominent exercise promoting factors of phase one, will then be included in the game. At the end of phase two this study delivers an exercise game for children with asthma. This will be finally tested in phase three of the SIMBA study for which a new METC approval will be submitted.
For the first phase 36 children with asthma and 18 parents will be invited to visit a onetime-meeting to assess factors that restrict and promote exercise behavior and collect ideas on how to increase the physical activity level in children with asthma. For healthcare professionals phase one consist of two online assignments. In phase two, four children, four parents and four healthcare professionals are invited to participate in two sound board meetings to provide feedback and give input on developed prototypes of the exercise game for children with asthma.
For phase one participants are invited on a central location close to their home address. The participation in the study will take approximately one day (or 2 h online for healthcare professionals). For phase 2 participation takes two times for a maximum of one and a half hour. Participation is without risks for the patients, parents and healthcare professionals. Due to the nature and content of the study it is expected that children will enjoy participation in the study and are free to join.
|- Main changes (audit trail)|
|- RECORD||21-aug-2017 - 3-sep-2017|