Trial document




drksid header

  DRKS00007798

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

FatiGo-Study

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

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

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language


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

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007798
  •   2015/05/05
  •   [---]*
  •   yes
  •   Approved
  •   17-157, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F48 -  Other neurotic disorders
  •   Fatigue
end of 1:N-Block indications
start of 1:N-Block interventions

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 )
end of 1:N-Block interventions
start of 1:1-Block design

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
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/11/17
  •   125
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   69   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Köln - CIO
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Hubertus Wald Tumorzentum Universitäres Cancer Center Hamburg Universitätsklinikum Hamburg-Eppendorf
    • Ms.  PD Dr.  Marianne  Sinn 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinische Klinik und Poliklinik II, CCC MF
    • Ms.  Dr. med.  Claudia  Löffler 
    • Oberdürrbacher Str. 6
    • 97078  Würzburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Uniklinik Köln - CIO
    • Mr.  PD Dr.  Freerk  Baumann 
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinik Köln - CIO - OTT
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Uniklinik Köln - CIO
    • Kerpener Straße 62 Uniklinik Köln / Gebäude 70
    • 50937  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.