SIMBA study 2|
|- candidate number||29734|
|- NTR Number||NTR7578|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-okt-2018|
|- Secondary IDs||NL66363.018.18 |
|- Public Title||SIMBA study 2|
|- Scientific Title||Stimulating physical activity in children with asthma, a feasibility study|
|- hypothesis||The SIMBA app will be usable and feasible during care for children with asthma. The app, to stimulate physical activity, will help children with asthma and their healthcare providers to increase the effects of physical activity stimulation care. |
|- Healt Condition(s) or Problem(s) studied||Children, Asthma|
|- Inclusion criteria||In this study, children may participate when they are 8, 9, 10 or 11 years of age; are at elementary school; and are diagnosed with asthma by a pediatrician or general practitioner. The asthma needs to be in a (relatively) stable stage, as indicated by their pediatrician. The children need to be able to perform PA (either with or without asthma medication). The health of the participating child needs to benefit from an increased daily PA level. |
At time of inclusion the participators need to have a sedentary lifestyle. For this study this includes inactive children (couch lovers); lightly active children, participating in physical education class at school without regular sports activities; or moderate active children, participating in a maximum of 1 or 2 exhausting, high intensive physical activities per week.
High intensive PA is defined as activities with a Ďmetabolic equivalent of taskí (MET) score of 6 and above. This includes activities like tennis, running, soccer and hockey, basketball, sport-climbing and biking.
|- Exclusion criteria||Children with another (chronic) disease, or mental/ physical co-morbidity that reduces the ability to be physically active (excluding obesity). Children who do not understand, speak, read and/or write the Dutch language. Children who donít have Wi-Fi access at their home. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-nov-2018|
|- planned closingdate||1-mei-2019|
|- Target number of participants||35|
|- Interventions||The SIMBA app is called Foxfit. It is intended to be used as an additional tool for health-care providers. The SIMBA app is a gamification of the triangle of (a) child with asthma, (b) the health-care provider and (c) the childís PA behavior performance. The SIMBA app includes tailored communication and goalsetting, combined with feedback on performed PA and education about asthma, warming-up, breathing techniques, and medication use in relation to exercise. |
|- Primary outcome||Feasibility and usability|
|- Secondary outcome||Physical activity performance (patterns and level). |
Estimated exercise capacity (6-min walk test). Enjoyment during physical activity.
Self-competence related to sports and exercise activities.
|- Timepoints||T0 - baseline|
T3 - after three weeks (halfway intervention)
T6 - end of intervention
|- Trial web site||http://www.hva.nl/achieve/gedeelde-content/contentgroep/simba/simba.html|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD. PT. R.H.H. Engelbert|
|- CONTACT for SCIENTIFIC QUERIES||Drs. K.I. Braam|
|- Sponsor/Initiator ||Amsterdam Center for Innovative Health Practice, Faculty of Health|
(Source(s) of Monetary or Material Support)
|- Publications||Wat stimuleert kinderen met astma om meer te gaan bewegen? IdeeŽn van het kind, de ouder en de zorgverlener. Braam, K. I., Brons, A. E., Broekema, W. A., Visser, B., Altenburg, T. M., Chin A Paw, M. J. M. & Engelbert, R. H. H. 2018 In : Beweegreden. 14, 3, 3 p.|
|- Brief summary||Objective: To assess the feasibility and usability of the SIMBA app for children with asthma and their health-care providers and, in addition, to observe factors of success of the app. |
Study design: A feasibility-study.
Study population: Severely decreased to moderate active children, with a stable state of asthma, aged eight to twelve years old, without co-morbidity (other than obesity) influencing cognitive- or physical functioning.
A total of 35 children will be included through participating health-care providers.
Intervention: A newly developed SIMBA app will be used as a tool by health-care providers and children with asthma to stimulate and motivate children with asthma to increase their PA level. The SIMBA app is a gamification of the triangle of (a) child with asthma, (b) the health-care provider and (c) the childís PA behavior performance. The SIMBA app includes tailored communication and goalsetting, combined with feedback on performed PA and education about asthma, warming-up, breathing techniques, and medication use in relation to exercise.
The intervention is a treatment program which will be introduced when a child with asthma needs activity stimulation. It is aimed to increase the efficacy of the PA stimulation health-care process. For the child the intervention includes a PA monitor (worn by the child on a daily basis) and an enjoyable app with personal education, feedback and rewards. For the health-care provider the intervention includes a dashboard on which the PA of the child can be shown, activities can be planned and goals can be set. The planning of activities and goal setting will be performed together with the child and its parent(s). All data communication will be performed under study code and therefore will not include patient information.
Methods: At the first week of the study the child will wear a physical activity monitor to assess unstimulated PA level of the participating children with asthma. After that, the actual 6-week feasibility study starts to assess the feasibility of the intervention. Feasibility will be assessed during and at the end of the study period using questionnaires. Data to signalize signs of success factors, like increase of PA and enjoyment of performing PA will be obtained at baseline and directly after the final week of the intervention. These additional intervention outcomes include state of asthma control, the estimated exercise capacity, PA performance, PA enjoyment and self-efficacy of the children. These will be assessed by questionnaires. The 6-min walk test will be used to estimate exercise capacity.
At the end of the study there is a report on the feasibility of the SIMBA app and information on health stimulators and facilitators of the app.
|- Main changes (audit trail)|
|- RECORD||29-okt-2018 - 6-nov-2018|
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