Skip to main content
OpenTrials
Completed

NCT Number: NCT04663516

Effectiveness of Exercise Through Video Games in Reducing Fatigue Among Children With Leukemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fatigue Childhood ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Fahad Medical City

Riyadh, 11564, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exergaming

Other

games provided by the console requiring the movement of upper body, lower body and trunk.

Primary outcomes

  1. pediatric quality of life multidimensional fatigue scale

    Time frame: 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.

  2. six minute walk test

    Time frame: 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.

Secondary outcomes

  1. the Godin shepherd leisure time physical activity questionnaire

    Time frame: one week

    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.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Effectiveness of Exergaming in Reducing Fatigue Among Children With Leukemia

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.