NCT04663516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

November 27, 2020

Last Update Submit

February 9, 2021

Conditions

Keywords

ExergamingfatigueLeukemiaChildren

Outcome Measures

Primary Outcomes (2)

  • 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.

    one month

  • 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.

    one month

Secondary Outcomes (1)

  • the Godin shepherd leisure time physical activity questionnaire

    one week

Study Arms (2)

experimental

EXPERIMENTAL

exercise through video game (Wii)

Other: Exergaming

control

NO INTERVENTION

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

Interventions

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

experimental

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months.

You may not qualify if:

  • bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Fahad Medical City

Riyadh, 11564, Saudi Arabia

Location

MeSH Terms

Conditions

FatiguePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • afnan masoud

    MSc student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 11, 2020

Study Start

September 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations