Trial document




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  DRKS00020902

Trial Description

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Title

Influence of different physiological exercise forms as well as a relaxation intervention on cancer-related fatigue, the current state of health and haematological / endocrinological parameters in paediatric oncological patients in acute therapy

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Trial Acronym

MORE!
MOve&RElax

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The present research project will investigate the influence of different physiological training forms and a relaxation intervention on the current state of health, the CRF, as well as the supposedly related parameters of the hematological / endocrinological spectrum in pediatric oncological patients in acute therapy.

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Brief Summary in Scientific Language

Due to the positive effects of sport and exercise on the physical, psycho-mental and social levels, supportive therapeutic interventions in movement therapy are also gaining in importance in curative child oncology. In recent years, the feasibility of such interventions in the course of therapy has been demonstrated and evidence of positive effects on physical performance and quality of life has been provided in individual cases. Nevertheless, there is still a great need for action in this field of research, e.g. with regard to the optimal type of exercise therapy and control and its effects. There is also a lack of meaningful studies that compare different forms of intervention. Against this background, the present research project will investigate the influence of different physiological training forms and a relaxation intervention on the current state of health, the CRF, as well as the supposedly related parameters of the hematological / endocrinological spectrum in pediatric oncological patients in acute therapy.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Sensitive Data

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Organizational Data

  •   DRKS00020902
  •   2020/03/13
  •   [---]*
  •   yes
  •   Approved
  •   027/2020, Deutsche Sporthochschule Köln Am Sportpark Müngersdorf 6 50933 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

  •   Relaxation intervention
  •   Exergaming
  •   Strength, endurance, mobilisation
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Effects of a 4-week relaxation intervention or two different 6-week physiological training forms on the CRF, the current state of health and the hematological and endocrinological parameters

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Secondary Outcome

Influence of the frequency of intervention participation on the development of CRF, the current state of health and hematological and endocrinological parameters

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/06/01
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with an oncological disease (ICD10 C00-C97) who are undergoing inpatient or outpatient treatment in the Department of Paediatric Oncology and Haematology at Cologne University Hospital and who are receiving chemotherapeutic treatment
- Gender: Both male and female
- Minimum age: ≥ 6 years
- Maximum age: < 18 years
- from the point of view of the attending physicians, sports activities are possible within the training program
- The written consent of a parent or legal guardian as well as of the student has been obtained

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Exclusion Criteria

- special stress circumstances (on doctor's recommendation)
- severe physical and/or psychological impairments that make it impossible to participate in the exercise programme
- serious chronic diseases excluding regular physical activity
- poor speech comprehension

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Addresses

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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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    • Pädiatrische Onkologie und HämatologieUniklinik Köln
    • Mr.  Prof.  Thorsten  Simon 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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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 planned
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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.