NCT01748058

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable cancer

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

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

4.5 years

First QC Date

October 15, 2012

Last Update Submit

December 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accelerometer, average counts of dynamic acceleration (physical activity)

    Change in the children's physical activity levels with accelerometer

    1 week at baseline and at 12 months

Secondary Outcomes (4)

  • Movement assessment battery for children (M-ABC-2) scores (motor performance)

    At baseline, 2, 6, 12 and 24 months

  • PedsQL Multidimensional Fatigue Scale scores (fatigue)

    At baseline, 2, 6, 12 and 24 months

  • Blood sugar

    At baseline, 2, 6, 12 and 24 months

  • Blood insulin

    At baseline, 2, 6, 12 and 24 months

Study Arms (2)

Active video games

EXPERIMENTAL

Exercise based on active video gaming

Behavioral: Exercise based on active video gaming

Routine care

NO INTERVENTION

Interventions

Active video games

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • cancer diagnose
  • treated with Vincristine in Turku University Hospital or Tampere University Hospital

You may not qualify if:

  • other diseases limiting functional ability
  • not able to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

Related Publications (2)

  • 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.

  • Kauhanen 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.

Related Links

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 15, 2012

First Posted

December 12, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations