Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04663516
Other study ID # ONCO-EXERGAME
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2020

Study information

Verified date February 2021
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Saudi Arabia King Fahad Medical City Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. one week
See also
  Status Clinical Trial Phase
Completed NCT04959214 - The Effect Of Progressıve Relaxatıon Exercıses N/A
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Completed NCT04531891 - Utility and Validity of a High-intensity, Intermittent Exercise Protocol N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT04960865 - Kinesio Taping and Calf Muscle Fatigue N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A
Active, not recruiting NCT05344183 - Immediate and Short-term Effects of Low-level Laser N/A
Completed NCT04716049 - Effectiveness of Recovery Protocols in Elite Professional Young Soccer Players N/A
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05241405 - Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer N/A
Active, not recruiting NCT06074627 - Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes N/A
Completed NCT03943212 - The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis N/A
Recruiting NCT05567653 - Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers N/A
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT05863897 - e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury N/A
Not yet recruiting NCT05002894 - Effect of Pilates Exercises On Fatigue In Post Menopausal Women N/A
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT02911649 - Reducing Sedentary Behaviour With Technology N/A
Completed NCT02321358 - Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors N/A