Active Video Games to Promote Physical Activity in Children With Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Turku
Tampere University Hospital
Information provided by (Responsible Party):
Päivi Lähteenmäki, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01748058
First received: October 15, 2012
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Cancer
Behavioral: Exercise based on active video gaming

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Accelerometer, average counts of dynamic acceleration (physical activity) [ Time Frame: 1 week at baseline and at 12 months ] [ Designated as safety issue: No ]
    Change in the children's physical activity levels with accelerometer


Secondary Outcome Measures:
  • Movement assessment battery for children (M-ABC-2) scores (motor performance) [ Time Frame: At baseline, 2, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Change in M-ABC scores

  • PedsQL Multidimensional Fatigue Scale scores (fatigue) [ Time Frame: At baseline, 2, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Change in experienced fatigue

  • Blood sugar [ Time Frame: At baseline, 2, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Change in blood sugar

  • Blood insulin [ Time Frame: At baseline, 2, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Change in blood insulin


Enrollment: 36
Study Start Date: January 2013
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active video games
Exercise based on active video gaming
Behavioral: Exercise based on active video gaming
No Intervention: Routine care

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • other diseases limiting functional ability
  • not able to communicate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748058

Locations
Finland
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
University of Turku
Tampere University Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Päivi Lähteenmäki, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01748058     History of Changes
Other Study ID Numbers: T87/2012 
Study First Received: October 15, 2012
Last Updated: April 19, 2016
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on July 28, 2016