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Active Video Games to Promote Physical Activity in Children With Cancer

This study is currently recruiting participants.
Verified March 2013 by Turku University Hospital
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: March 4, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Accelerometer, average counts of dynamic acceleration (physical activity) [ Time Frame: 1-2 weeks at baseline, 2, 6, 12 and 24 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) 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


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Primary Completion Date: December 2016 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748058

Contacts
Contact: Lotta Kauhanen, PhD-student anloka@utu.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland
Contact: Päivi Lähteenmäki, Docent         paivi.maria.lahteenmaki@tyks.fi    
Contact: Lotta Kauhanen, PT, PhD-stdt         anloka@utu.fi    
Sponsors and Collaborators
Turku University Hospital
University of Turku
Tampere University Hospital
  More Information

No publications provided

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: March 4, 2013
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on May 16, 2013