Effectiveness of Exergaming in Reducing Fatigue Among Children With Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- pediatric quality of life multidimensional fatigue scale
研究概览
简要总结
40 children with cancer who fulfills the inclusion criteria will be included. Participants will be recruited from King Fahad Children's Cancer Center, King Fahad Medical City and King Khaled University Hospital. After obtaining written formal consent, children will be randomly assigned to two groups, control and experimental. Experimental group will play 60 minutes of Wii physical activity games for three weeks, twice each week. while control group will receive conventional therapy. Fatigue will be assessed using pediatric multidimensional fatigue scale- child proxy before, weekly during the study and after. Functional capacity will be measured by six minute walk test before and after study duration, and physical activity will be repeatedly measured by godin-shephard leisure time physical activity questionnaire. All data will be analyzed using appropriate statistical analysis.
详细描述
The intervention group:
The investigator will:
- handle accompanying each child to the play room, turn on the Wii and ask the child to choose the game he/she prefers to play from the games provided by wii console that requires the movement of the whole body: upper, lower and trunk.
- Monitor the child while playing, helping with the instructions of the game if the child needs assistance as it is only provided in English from the console.
- heart rate and oxygen saturation are planned to be measured every 15 minutes.
The duration is designed to be 60 minutes per session, but the child is allowed to rest for the time needed during the session if he/she feels tired. or if the oxygen saturation of the child reaches 93. or the heart rate reaches the predicted maximum heart rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months.
排除标准
- •bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.
结局指标
主要结局
pediatric quality of life multidimensional fatigue scale
时间窗: one month
the scale measures fatigue in the dimensions of physical, sleep and rest and cognitive. the validated Arabic version will be used. the total score is 100, the higher the score the better the person is. the lower the score the more fatigued the person is.
six minute walk test
时间窗: one month
measures the endurance and capacity of walking, by measuring the distance walked in six minutes of continuous walking. the longer the distance walked in six minutes the better the endurance.
次要结局
- the Godin shepherd leisure time physical activity questionnaire(one week)
研究者
Afnan Masoud
principle investigator
King Saud University