Clinical trial NCT04277130: Effectiveness of Active Video Games in Children With Intellectual Disabilities
Official title: Intervention Study of Active Video Games on Intellectual Disabled Children's Physical Activity Level, Motor Ability and Physical Fitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: exergame
children with intellectual disability
physical activity
motor proficiency
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2020-02-20
Enrollment: 203
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Children with intellectual disabilities (ID) are more vulnerable to obesity when compared to the normal children (Getchell et al., 2012; Maiano, 2011). Active video games (AVGs) on physical activity (PA) behavior have attracted academic interest and exploration since 2000. It has been demonstrated that an intervention with AVGs is compatible with the school setting and behavioral change in health and PA (Lau, et al., 2015). However, special populations such as ID children and their needs have been neglected in this area (Martins, Carvalho \& Soares, 2011). ID children's PA behavior, motor ability and physical fitness is still an under-explored area.

Aims: To determine the effect of a prescribed AVG intervention on ID children's PA levels (sedentary, light, moderate, and vigorous), motor ability, and physical fitness. The intervention effects in children with mild intellectual disability will be explored.

Design: A standard two-arm parallel, single-blinded, randomized control cluster trial.

Schools: Participants will be recruited from six special schools in Hong Kong. Schools with same intellectual disability categories will be randomly assigned into intervention group and control group.

Participants: 200 Children aged 8\~18 years old with intellectual disabilities will be recruited.

Intervention: ID children randomized to the intervention group will participate in an AVG intervention 60 minutes per week for 12 weeks in their PE class, in addition to their usual activity levels. The research team will prescribe updated AVG consistent with moderate-vigorous intensity.

Control: The control group will continue with usual PA alone and will not receive the AVG intervention.

Analysis: Repeated measures mixed model (2 groups X 2 time points (12-week post- test and 8-week follow up test)) by SPSS 23.0 will be used to investigate the intervention effect on primary and secondary outcomes, adjusting for baseline characteristics and correlation between repeated observations.

Significance: This will be the pioneering study to provide definitive evidence for the impact of a prescribed AVG intervention on ID children's PA level, motor ability and physical fitness. If effective, this research will provide significant evidence from the innovative method to inform health professionals and PE teachers how to incorporate AVG to enhance physical active behaviors, motor ability and physical fitness in ID children. Finally they may be able to enjoy a better quality of life.


Eligibility criteria: Inclusion Criteria:

* students with ID (mild category) aged 8-18 years old from special education schools including primary and secondary schools;

Exclusion Criteria:

* students without physical disability.

Primary outcomes:
measure: Change of body mass index
timeFrame: through study completion, 12 weeks
measure: Change of body fat percentage
timeFrame: through study completion, 12 weeks
measure: Change of sedentary behavior time
timeFrame: through study completion, 12 weeks
measure: Change of light physical activity time
timeFrame: through study completion, 12 weeks
measure: Change of moderate-to-vigorous physical activity time
timeFrame: through study completion, 12 weeks
measure: Change of motor proficiency
timeFrame: through study completion, 12 weeks
measure: Change of muscular strength
timeFrame: through study completion, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Baptist University
name: Wing-Chung Lau, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: