跳至主要内容
临床试验/NCT04277130
NCT04277130已完成不适用

Intervention Study of Active Video Games on Intellectual Disabled Children's Physical Activity Level, Motor Ability and Physical Fitness

Hong Kong Baptist University0 个研究点目标入组 203 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
主要终点
Change of sedentary behavior time

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • students without physical disability.

结局指标

主要结局

Change of sedentary behavior time

时间窗: through study completion, 12 weeks

Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with lower than 100 counts per minute is categorized as sedentary behaviors. Overall time in sedentary behavior in minute is recorded as sedentary behavior time. Change of sedentary behavior time between baseline and post-intervention tests is assessed.

Change of muscular strength

时间窗: through study completion, 12 weeks

The hand dynamometer (Model 01160, Lafayette Instrument Company, Lafayette, Indiana, USA) is used to measure the muscular strength. Output is in kilograms (range 0.0-199.9kg with sensitivity at 0.1kg). The change of muscular strength between baseline and post-intervention tests is assessed.

Change of body mass index

时间窗: through study completion, 12 weeks

Weight (measured in kilograms) and height (measured in meters) are combined to report body mass index in kg/m\^2. Change of body mass index between baseline and post-intervention test is assessed.

Change of body fat percentage

时间窗: through study completion, 12 weeks

Body fat percentage is measured using the Tanita BC-418 Body Composition Analyzer at baseline and post-intervention test and is reported the unit as %. Change of body fat percentage between baseline and post-intervention test is assessed.

Change of light physical activity time

时间窗: through study completion, 12 weeks

Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with higher than 100 counts per minute but lower than 2296 counts per minute is categorized as light physical activity. Overall time in light physical activity in minute is recorded as light physical activity time. Change of light physical activity time between baseline and post-intervention tests is assessed.

Change of moderate-to-vigorous physical activity time

时间窗: through study completion, 12 weeks

Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with higher than 2296 counts per minute is categorized as moderate-to-vigorous physical activity. Overall time in moderate-to-vigorous physical activity in minute is recorded as moderate-to-vigorous physical activity time. Change of moderate-to-vigorous physical activity time between baseline and post-intervention tests is assessed.

Change of motor proficiency

时间窗: through study completion, 12 weeks

The short-form Bruininks-Oseretsky Test of Motor Proficiency™ - Second Edition (BOT-2) (Bruininks \& Bruininks, 2005) is used for the assessment of motor proficiency. The scale consists of 14 items and scored 0-88. Higher score indicates higher motor proficiency. Change of BOT-2 score between baseline and post-intervention tests is assessed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lau Wing Chung

Professor

Hong Kong Baptist University

相似试验

Effectiveness of Active Video Games in Children With... | 临床试验