FatigueNCT04663516
Effectiveness of Exercise Through Video Games in Reducing Fatigue Among Children With Leukemia
A study testing Exergaming in people with Fatigue and Childhood ALL, run by King Saud University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Fatigue, Childhood ALL
- What is being tested?
- Exergaming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months.
Who cannot join
- bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Exergaming 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.
Read the 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
- Being tested
- Exergaming
- Keywords
- Exergaming, fatigue, Leukemia, Children
- Medical subject headings
- Fatigue, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingOther
games provided by the console requiring the movement of upper body, lower body and trunk.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | exercise through video game (Wii) Receives: Other: Exergaming |
| control | No intervention | children in this group will be given advice about the importance of exercising |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one month
Secondary outcomes (1)
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Sep 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afnan Masoud, King Saud University
- Investigators
- afnan masoud, Principal investigator, MSc student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663516
- Sponsor's protocol ID
- ONCO-EXERGAME
- Status last verified
- Feb 2021
- First submitted
- 27 Nov 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exergaming in Reducing Fatigue Among Children With Leukemia
- ClinicalTrials.gov ID
- NCT04663516
- Acronym / sponsor ID
- ONCO-EXERGAME
- Conditions
- Fatigue, Childhood ALL
- Keywords
- Exergaming, fatigue, Leukemia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Exergamingexercise through video game (Wii) |
| control | No intervention | –children in this group will be given advice about the importance of exercising |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months.
Key exclusion criteria (1 listed)
- bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergaminggames provided by the console requiring the movement of upper body, lower body and trunk. | Other | experimental |
Primary outcome
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.
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.
1 secondary outcome
the Godin shepherd leisure time physical activity questionnaire
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
afnan masoud principal investigator
MSc student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming in people with Fatigue and Childhood ALL, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pediatric quality of life multidimensional fatigue scale (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.