Effectiveness of Exercise Through Video Games in Reducing Fatigue Among Children With Leukemia
Primary Purpose
Fatigue, Childhood ALL
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Exergaming
Sponsored by
About this trial
This is an interventional health services research trial for Fatigue focused on measuring Exergaming, fatigue, Leukemia, Children
Eligibility Criteria
Inclusion Criteria:
- diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months.
Exclusion Criteria:
- bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.
Sites / Locations
- King Fahad Medical City
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental
control
Arm Description
exercise through video game (Wii)
children in this group will be given advice about the importance of exercising
Outcomes
Primary Outcome Measures
pediatric quality of life multidimensional fatigue scale
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
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.
Secondary Outcome Measures
the Godin shepherd leisure time physical activity questionnaire
measures the units of physical activity done by the child, by multiplying the met value by the minutes of activity done per week. the scale measures units of activity, if one gets 0-18 it means the person is insufficiently active, 18-27 sufficiently active, if more that 27 then the person is active. the questionnaire consists of one question how many days did the person participate in activity, then we should multiply the number of days that person was active by 9 if the activity he/she did was vigorous, by 5 if the activity was moderate and by 3 if the activity was mild.
Full Information
NCT ID
NCT04663516
First Posted
November 27, 2020
Last Updated
February 9, 2021
Sponsor
King Saud University
1. Study Identification
Unique Protocol Identification Number
NCT04663516
Brief Title
Effectiveness of Exercise Through Video Games in Reducing Fatigue Among Children With Leukemia
Official Title
Effectiveness of Exergaming in Reducing Fatigue Among Children With Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Childhood ALL
Keywords
Exergaming, fatigue, Leukemia, Children
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental
Arm Type
Experimental
Arm Description
exercise through video game (Wii)
Arm Title
control
Arm Type
No Intervention
Arm Description
children in this group will be given advice about the importance of exercising
Intervention Type
Other
Intervention Name(s)
Exergaming
Intervention Description
games provided by the console requiring the movement of upper body, lower body and trunk.
Primary Outcome Measure Information:
Title
pediatric quality of life multidimensional fatigue scale
Description
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.
Time Frame
one month
Title
six minute walk test
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
the Godin shepherd leisure time physical activity questionnaire
Description
measures the units of physical activity done by the child, by multiplying the met value by the minutes of activity done per week. the scale measures units of activity, if one gets 0-18 it means the person is insufficiently active, 18-27 sufficiently active, if more that 27 then the person is active. the questionnaire consists of one question how many days did the person participate in activity, then we should multiply the number of days that person was active by 9 if the activity he/she did was vigorous, by 5 if the activity was moderate and by 3 if the activity was mild.
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months.
Exclusion Criteria:
bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
afnan masoud
Organizational Affiliation
MSc student
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Fahad Medical City
City
Riyadh
ZIP/Postal Code
11564
Country
Saudi Arabia
12. IPD Sharing Statement
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Effectiveness of Exercise Through Video Games in Reducing Fatigue Among Children With Leukemia
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