Trial document



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  DRKS00007798

Trial Description

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Title

Prospective, randomized, controlled study to evaluate the direct effect of specific movement therapy with professional supervision by various Inteventionen on the Fatigue Syndrome

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Trial Acronym

FatiGo-Study

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URL of the Trial

https://cio.uk-koeln.de/leben-mit-krebs/bewegung/studien-und-publikationen/

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Brief Summary in Lay Language


The Fatigo study should investigate the immediate effectiveness of supervised and targeted exercise therapy on the Fatigue Syndrome.

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Brief Summary in Scientific Language

Prospective, randomized, controlled study to evaluate the direct effect targeted movement therapy on fatigue syndrome. A total of 120 patients will be divided into five groups. Here, endurance and power groups differ with each moderate and high intensity and a control group. The training is supervised and located in the Oncology Training and Exercise therapy over a period of 4 weeks.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00007798
  •   2015/05/05
  •   [---]*
  •   yes
  •   Approved
  •   17-157, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   F48 -  Other neurotic disorders
  •   Fatigue
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Interventions/Observational Groups

  •   Control group (there will be no training, but patients fill about 4 week the questionnaires and can then work on the OTT)
  •   strength group (moderate intensity of 50-60%, the training takes place 3 times a week 30 minutes over a period of 4 weeks )
  •   endurance group (moderate intensit 50-60%, the training takes place 3 times a week 30 minutes over a period of 4 weeks ))
  •   Strength group ( high intensity 70-80%, the training takes place 3 times a week 30 minutes over a period of 4 weeks )
  •   endurance group ( high intensity 70-80%, the training takes place 3 times a week 30 minutes over a period of 4 weeks )
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, data analyst
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of the immediate effectiveness of targeted exercise therapy with professional supervision through various interventions on the fatigue syndrome (MFI20).

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Secondary Outcome


1. What intervention group and what intensity has the best effect on the Fatigue Syndrome?
2. What blood parameters play a role in fatigue?
3. Development of a training standard therapy

Assessments:
MFI20 = Fatigue
VAS = Fatigue
HADS = anxiety / depression
h1RM = force
Spiroergometry = endurance
Freiburg Questionnaire / movisens = physical activity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/11/17
  •   125
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients with a history of malignancy (all entities)
Patients in the follow-up
Fatigue VAS >3
completed chemotherapy
Age> = 18 years
written and valid informed consent

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Exclusion Criteria

• VAS <3
• Age> 69 years
• Hormone therapy
• Palliative patients or with advanced cancer
• Ongoing chemotherapy, ongoing radiation
• Conditions that cause fatigue
• Medications that can affect severe fatigue
• Activity level> 1 hour of exercise per week
• All illness situations that do not allow sporting activity, in particular:
o Clinically manifest heart failure (NYHA III-IV)
o Partial or global respiratory failure
o Permanent thrombocytopenia <10,000 / µl, e.g. refractory autoimmune thrombocytopenias
o Congenital or acquired thrombocytopathies or coagulation disorders
o Symptomatic CHD (exercise ECG and cardiac ultrasound recommended if necessary)
o Severe refractory hypertension
o Non-adjustable COPD
o Uncontrolled cerebral convulsions
o Severe anemia (requiring a transfusion)
o metastases
• Medical or mental health condition that, in the opinion of the investigator, does not allow the patient to take part in the study or to provide a legally binding consent form
• Unwillingness to save and pass on personal illness data within the scope of the protocol
• Participation in another sports study

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Addresses

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    • Uniklinik Köln - CIO
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
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    •   [---]*
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    • Hubertus Wald Tumorzentum Universitäres Cancer Center Hamburg Universitätsklinikum Hamburg-Eppendorf
    • Ms.  PD Dr.  Marianne  Sinn 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Medizinische Klinik und Poliklinik II, CCC MF
    • Ms.  Dr. med.  Claudia  Löffler 
    • Oberdürrbacher Str. 6
    • 97078  Würzburg
    • Germany
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    • Uniklinik Köln - CIO
    • Mr.  PD Dr.  Freerk  Baumann 
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
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    • Uniklinik Köln - CIO - OTT
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln - CIO
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.