CancerNCT01748058
Active Video Games to Promote Physical Activity in Children With Cancer
A study testing Exercise based on active video gaming in people with Cancer, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim of this study is to evaluate the efficacy and feasibility of active video gaming with regard to the promotion of physical activity and motor learning in children with cancer. Experienced fatigue, body mass index and the development of metabolic risk factors during treatment are also examined. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise based on active video gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to Jul 2017
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cancer diagnose
- treated with Vincristine in Turku University Hospital or Tampere University Hospital
Who cannot join
- other diseases limiting functional ability
- not able to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Video Games to Promote Physical Activity, Motor Performance and Quality of Life in Children With Cancer: an Intervention Study With 2-year Follow-up
The aim of this study is to evaluate the efficacy and feasibility of active video gaming with regard to the promotion of physical activity and motor learning in children with cancer. Experienced fatigue, body mass index and the development of metabolic risk factors during treatment are also examined.
- Conditions
- Cancer
- Being tested
- Exercise based on active video gaming
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise based on active video gamingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Active video games | Experimental | Exercise based on active video gaming Receives: Behavioral: Exercise based on active video gaming |
| Routine care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer, average counts of dynamic acceleration (physical activity)
Change in the children's physical activity levels with accelerometer
Measured: 1 week at baseline and at 12 months
Secondary outcomes (4)
Movement assessment battery for children (M-ABC-2) scores (motor performance)
Change in M-ABC scores
Measured: At baseline, 2, 6, 12 and 24 months
PedsQL Multidimensional Fatigue Scale scores (fatigue)
Change in experienced fatigue
Measured: At baseline, 2, 6, 12 and 24 months
Blood sugar
Change in blood sugar
Measured: At baseline, 2, 6, 12 and 24 months
Blood insulin
Change in blood insulin
Measured: At baseline, 2, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku, Tampere University Hospital
- Responsible party
- Principal investigator, Päivi Lähteenmäki, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748058
- Sponsor's protocol ID
- T87/2012
- Status last verified
- Dec 2019
- First submitted
- 15 Oct 2012
- Last updated
- 23 Dec 2019
- Results posted
- No
Publications
Hamari L, Jarvela LS, Lahteenmaki PM, Arola M, Axelin A, Vahlberg T, Salantera S. The effect of an active video game intervention on physical activity, motor performance, and fatigue in children with cancer: a randomized controlled trial. BMC Res Notes. 2019 Nov 29;12(1):784. doi: 10.1186/s13104-019-4821-z.
PubMed 31783907Kauhanen L, Jarvela L, Lahteenmaki PM, Arola M, Heinonen OJ, Axelin A, Lilius J, Vahlberg T, Salantera S. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up. BMC Pediatr. 2014 Apr 5;14:94. doi: 10.1186/1471-2431-14-94.
PubMed 24708773
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Video Games to Promote Physical Activity, Motor Performance and Quality of Life in Children With Cancer: an Intervention Study With 2-year Follow-up
- ClinicalTrials.gov ID
- NCT01748058
- Acronym / sponsor ID
- T87/2012
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku, Tampere University Hospital
- Study start
- Jan 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Dec 2012 (estimated)
- 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.
The aim of this study is to evaluate the efficacy and feasibility of active video gaming with regard to the promotion of physical activity and motor learning in children with cancer. Experienced fatigue, body mass index and the development of metabolic risk factors during treatment are also examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active video games | Experimental | Behavioral: Exercise based on active video gamingExercise based on active video gaming |
| Routine care | No intervention | – |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- cancer diagnose
- treated with Vincristine in Turku University Hospital or Tampere University Hospital
Key exclusion criteria (2 listed)
- other diseases limiting functional ability
- not able to communicate
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 |
|---|---|---|
| Exercise based on active video gaming | Behavioural | Active video games |
Primary outcome
Accelerometer, average counts of dynamic acceleration (physical activity)
Time frame: 1 week at baseline and at 12 months
Change in the children's physical activity levels with accelerometer
4 secondary outcomes
Movement assessment battery for children (M-ABC-2) scores (motor performance)
Time frame: At baseline, 2, 6, 12 and 24 months
PedsQL Multidimensional Fatigue Scale scores (fatigue)
Time frame: At baseline, 2, 6, 12 and 24 months
Blood sugar
Time frame: At baseline, 2, 6, 12 and 24 months
Blood insulin
Time frame: At baseline, 2, 6, 12 and 24 months
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 23 Dec 2019.
- Derived from this study: PubMed 31783907Hamari L, Jarvela LS, Lahteenmaki PM, Arola M, Axelin A, Vahlberg T, Salantera S. The effect of an active video game intervention on physical activity, motor performance, and fatigue in children with cancer: a randomized controlled trial. BMC Res Notes. 2019 Nov 29;12(1):784. doi: 10.1186/s13104-019-4821-z.
- Derived from this study: PubMed 24708773Kauhanen L, Jarvela L, Lahteenmaki PM, Arola M, Heinonen OJ, Axelin A, Lilius J, Vahlberg T, Salantera S. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up. BMC Pediatr. 2014 Apr 5;14:94. doi: 10.1186/1471-2431-14-94.
- Study protocolLink provided by the sponsor.
- ResultsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise based on active video gaming in people with Cancer, run by Turku University Hospital at 1 site in Finland.
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 2 inclusion and 2 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 23 Dec 2019. 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 Finland. 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?
Accelerometer, average counts of dynamic acceleration (physical activity) (time frame: 1 week at baseline and at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748058, which also lists 2 linked publications.
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 23 Dec 2019.