Trial document





This trial has been registered retrospectively.
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  DRKS00015317

Trial Description

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Title

Evaluation of the exercise programs for childhood cancer patients offered by the German Sports University Cologne in the Children’s Hospital Amsterdamer Straße

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Survival rates in pediatric oncology are rising. This is why supportive therapy is gaining more importance to promote children’s and adolescents’ quality of life and to avoid therapy related side and late effects. Exercise programs, for example, are offered to counteract inactivity and physical decline, often reported in childhood cancer patients and survivors.
In the present study, the exercise programs for childhood cancer patients offered by the German Sports University Cologne in the Children’s Hospital Amsterdamer Straße are evaluated. Children and adolescence with cancer have the chance to receive exercise therapy starting from diagnosis and until full reintegration into active life – through an inpatient exercise program offered during intense cancer treatment, as well as through an outpatient exercise program or motor performance testing offered during maintenance therapy and aftercare. Program acceptance by the participating children and their healthy siblings or friends, potential barriers and obstacles, as well as program satisfaction by the participants and their parents, are assessed. Therefore, adherence, reasons for non-participation, adverse events and session protocols (performed exercises, intensity, and physical condition of the participants) are continuously documented. A questionnaire assessing program satisfaction is offered. Moreover, motor performance at the end of inpatient cancer treatment is assessed (MOT 4-6, DMT 6-18).
Potential study participants are children and adolescence (age: 2 – 22 years) that are being or were treated at the Children’s Hospital Amsterdamer Straße due to an oncological disease. Healthy siblings and friends (age: 2 – 2 years) can participate, as well.

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Brief Summary in Scientific Language

Survival rates in pediatric oncology are rising due to improved treatment regimen and differentiated diagnostics. As, such, supportive therapy is gaining more importance to promote children’s and adolescents’ quality of life and to avoid therapy related side and late effects. Exercise programs, for example, are offered to counteract inactivity and physical decline, often reported in childhood cancer patients and survivors.
In the present study, the exercise programs for childhood cancer patients offered by the German Sports University Cologne in the Children’s Hospital Amsterdamer Straße are evaluated. Children and adolescence with cancer have the chance to receive exercise therapy starting from diagnosis and until full reintegration into active life – through an inpatient exercise program offered during intense cancer treatment, as well as through an outpatient exercise program or motor performance testing offered during maintenance therapy and aftercare. Program acceptance by the participating children and their healthy siblings or friends, potential barriers and obstacles, as well as program satisfaction by the participants and their parents, are assessed. Therefore, adherence, reasons for non-participation, adverse events and session protocols (performed exercises, intensity, and physical condition of the participants) are continuously documented. A questionnaire assessing program satisfaction is offered. Moreover, motor performance at the end of inpatient cancer treatment is assessed using age-appropriate motor assessment methods (MOT 4-6, DMT 6-18).
Potential study participants are children and adolescence (age: 2 – 22 years) that are being or were treated at the Children’s Hospital Amsterdamer Straße due to an oncological disease. Healthy siblings and friends (age: 2 – 2 years) can participate, as well.

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Organizational Data

  •   DRKS00015317
  •   2019/04/04
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  •   yes
  •   Approved
  •   74/2018, Köln - Ethikkommission der Deutschen Sporthochschule Kön
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Secondary IDs

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Health Condition or Problem studied

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

  •   Childhood cancer patients participating at the inpatient exercise program offered during intense cancer treatment (PG1)
  •   Childhood cancer patients participating at the outpatient exercise program offered during maintenance therapy and aftercare (PG2)
  •   Childhood cancer patients participating at the motor performance testing (PG3)
  •   healthy siblings and friends participating at the inpatient exercise program offered during the intense cancer treatment of childhood cancer patients (GG1)
  •   healthy siblings and friends participating at the outpatient exercise program offered during the maintenance therapy or aftercare of childhood cancer patients (GG2)
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Adherence (documentation of the number of offered and attended sessions)

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Secondary Outcome

• Reasons for non-participation at the training sessions or study drop out (continuous documentation)
• Reasons for training cancellation (continuous documentation)
• Intensity of training sessions (heart rate monitoring during training sessions; assessment of perceived exertion using BORG-scale)
• Session protocols (continuous documentation of performed exercises)
• Physical condition (assessment of perceived physical condition before and at the end of each training session using a three-stage smiley-scale)
• adverse events (documentation of exercise-related adverse events leading to health deteriorations
• program satisfaction (assessment of program satisfaction using a self-developed questionnaire)
• motor performance testing (MOT 4-6 or DMT 6-18; performed after cessation of inpatient cancer treatment)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/07/19
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   22   Years
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Additional Inclusion Criteria

Inclusion criteria (for all patient groups, PG1, Pg2 and PG3)
• Age between 2 and 22 years
• Childhood cancer disease
• Medical treatment at the Children's hospital Amsterdamer Straße, Cologne
• medical clearance of the treating physician
• informed consent from the legal guardian and the participant



Inclusion criteria (for all healthy comparison groups, GG1 and GG2)
• Age between 2 and 22 years
• Healthy siblings or friends of a childhood cancer patient
• informed consent from the legal guardian and the participant

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Exclusion Criteria

exclusion criteria (for all groups)
• specific impairments (following physician’s advice)

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Addresses

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    • Deutsche Sporthochschule KölnInstitut für Kreislaufforschugn und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Mr.  Prof.  Wilhelm  Bloch 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbH, Kinderkrankenhaus Amsterdamer Straße, Kinderonkologie/ -hämatologie
    • Mr.  Dr. Dr.  Aram  Prokop 
    • Amsterdamer Straße 59
    • 50735  Köln
    • Germany
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    • Deutsche Sporthochschule KölnInstitut für Kreislaufforschung und SportmedizinAbteilung Molekulare und Zelluläre Sportmedizin
    • Ms.  Dr.  Julia  Däggelmann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule KölnInstitut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Ms.  Dr.  Julia  Däggelmann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Lukas Podolski Stiftung
    • 22765  Hamburg
    • Germany
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    • Wir helfen - eine Aktion des Kölner Stadtanzeigers
    • 50933  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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