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

NCT ID: NCT04663516

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-31

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.

Conditions

Fatigue; Childhood ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

experimental

exercise through video game (Wii)

Group Type: EXPERIMENTAL

Exergaming

Intervention Type: OTHER

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

control

children in this group will be given advice about the importance of exercising

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exergaming

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Afnan Masoud

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

afnan masoud

Role: PRINCIPAL_INVESTIGATOR

MSc student

Locations

King Fahad Medical City

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

ONCO-EXERGAME

Identifier Type: -

Identifier Source: org_study_id