Trial document




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  DRKS00004735

Trial Description

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Title

Integrability of a computer-based exercise program in the Pediatric Oncology and effects on fatigue syndrome and quality of life in pediatric oncology patients.
PAPO - „Physical Activity in the Pediatric Oncology“

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Trial Acronym

PAPO

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to research the integrability of a child-friendly computer-based exercise program in the inpatient and outpatient pediatric oncology hospital. In addition, effects of the intervention on quality of life and fatigue syndrome should be detected.

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Brief Summary in Scientific Language

The benefits of physical activity in cancer therapy in adults are well documented. In addition to an increase of physical performance there can be positive effects on quality of life and reduction in fatigue syndrome. In pediatric oncology this approach has not been sufficiently explored. The aim of this study is to research the integrability of a child-friendly computer-based exercise program in the pediatric oncology as well as the effects of the intervention on quality of life and fatigue syndrome. Results could underline the need for exercise therapy as an useful supportive therapy in pediatric oncology.

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Organizational Data

  •   DRKS00004735
  •   2013/02/13
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  •   yes
  •   Approved
  •   2/2013, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Computer-based exercise program for pediatric oncology patients while stationary and outpatient hospital stay during three month. Exercise program takes place once a week, duration and intensity is determined depending on day form. Guidance for the intervention duration is 30 minutes.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Integrability of the computer-based exercise program in in-patient and out-patient hospital will be determined by drop-out and evaluation of the training diary after three months.

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Secondary Outcome

At study start, every month and study end health-related quality of life (KINDL) and fatigue syndrome (PEDsQL multidimensional Fatigue-scale) will be assessed by questionare.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/07/15
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   18   Years
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Additional Inclusion Criteria

Oncology inpatient or outpatient treatment, aged between 6 and 18 years, hemoglobin and heart rate in normal range, no infections, following the occurrence of the medical certificate of the attending physician.

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Exclusion Criteria

Special conditions (on medical recommendation), hard physical or mental impairment so that the participation on the exercise program is not possible.

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Addresses

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    • Deutsche Sporthochschule Köln, Institut für Bewegungs- und Neurowissenschaft
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Uniklinik Köln, Pädiatrische Onkologie und Hämatologie
    • Mr.  Prof. Dr. med.  Frank  Berthold 
    • Köln
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    • Deutsche Sporthochschule Köln, Institut für Bewegungs- und Neurowissenschaft
    • Ms.  Dr.  Anna-Maria  Platschek 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Bewegungs- und Neurowissenschaft
    • Ms.  Dr.  Anna-Maria  Platschek 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln, Institut für Bewegungs- und Neurowissenschaft
    • Ms.  Dr.  Anna-Maria  Platschek 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/28
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.