Trial document





This trial has been registered retrospectively.
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  DRKS00004450

Trial Description

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Title

Effects of a targeted, individualized sports therapy program for childhood cancer patients on motor Performance

Publication: Beulertz J, Prokop A, Rustler V, Bloch W, Felsch M, Baumann FT. Effects of a 6-Month, Group-Based, Therapeutic Exercise Program for Childhood Cancer Outpatients on Motor Performance, Level of Activity, and Quality of Life. Pediatric Blood and Cancer. 2016;63(1):127-132.

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Trial Acronym

Escimo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to examine the effect of a 6-month targeted, individualized sports therapy program for childhood cancer patients on physiological, psychological and social parameters. The main objective is to determine the effect on motor performance. Therefore, 69 children will be included according to defined inclusion and exclusion critieria. The intervention group consists of childhood cancer patients participating in the sports program. The first control group includes patients not particpating in the program while the second group contains healthy peers. Some changes in the study protocol (adding the second control group and therefore increasing the number of participants, reducing the number of secondary outcomes and adjusting the inclusion criteria) were made according to an amendment.

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Brief Summary in Scientific Language

The aim of this non-randomized, controlled trial ist to examine the effect of a targeted, individualized sportstherapy within a representative sample of childhood cancer patients after inpatient, medical treatment. While patients of the intervention group take part in a 6-month targeted, individualized sports therapy program, patients of the control group do not attend any intervention. Healthy children (siblings and friends) serve as a second control group. Outcomes are motor performance, health-related quality of life and level of activity.

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Organizational Data

  •   DRKS00004450
  •   2012/10/09
  •   [---]*
  •   yes
  •   Approved
  •   40/2012, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   childhood cancer
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Interventions/Observational Groups

  •   6-month sports therapy program for childhood cancer patients after inpatient medical treatment (once a week, 60 minutes)
  •   childhood cancer patients; no intervention
  •   healthy children; no intervention
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Motor performance of all study participants are examined using standardized motor test batteries (MOT 4-6; DMT 6-18) with study entry (baseline), after 3 month (only intervention group) and after 6 month.

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Secondary Outcome

Health-related quality of life (KINDL-questionnaire and oncology module) and level of activity (modified MoMo-questionnaire) are examined with study entry (baseline), after 3 month (only intervention group) and after 6 month.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/07/18
  •   69
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Years
  •   17   Years
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Additional Inclusion Criteria

IG and CG (1): oncological treatment, cessation of inpatient medical treatment, between four and seventeen years of age, diagnosis less than five years ago, hemoglobin and heart rate within normal range, no infections, medical clearance from the treating physician, informed consent from legal Guardian
CG (2): healthy children, matched pair (age and gender) to IG, informed consent from legal guardian

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Exclusion Criteria

specific stresses (according to the physicians advice), specific physiological and/or psychosocial impairments (according to the physicians advice)

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Addresses

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Mr.  Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Mr.  Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Ms.  Dipl.Sportwiss.  Julia  Beulertz 
    • 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 Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Mr.  Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/31
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Trial Publications, Results and other Documents

  •   Beulertz J, Prokop A, Rustler V, Bloch W, Felsch M, Baumann FT. Effects of a 6-Month, Group-Based, Therapeutic Exercise Program for Childhood Cancer Outpatients on Motor Performance, Level of Activity, and Quality of Life. Pediatric Blood and Cancer. 2016;63(1):127-132.
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* This entry means the parameter is not applicable or has not been set.