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

[---]*

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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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Organizational Data

  •   DRKS00007798
  •   2015/05/05
  •   [---]*
  •   yes
  •   Approved
  •   43/2015, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

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Health Condition or Problem studied

  •   F48.0 -  Neurasthenia
  •   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
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, 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

The aim of this study is to evaluate the immediate effectiveness of targeted exercise therapy with professional supervision by various interventions on fatigue syndrome.


1 HADS
The HADS questionnaire was developed in studies with cancer patients to psychological well-being to be determined. The items include questions to anxiety and depression. In the end, two subscales HADS-D anxiety resulting value is the sum A1 to A7 and HADS-Depression S-value = sum D1 to D7. The questionnaire is filled in at preassesment and at the final testing ( after the 4 weeks of training).

10.3.2 MFI20
This is an evaluation sheet for fatigue symptoms. The questionnaire consists of 20 questions (true yes, that too) on a scale of 1 to 5 (no, this is not true) to be answered. The questionnaire should be filled out once a week.

10.3.3. Freiburg Questionnaire
This questionnaire focuses on physical activity. The questionnaire-hold 8 questions which asked for the physical activities of the last week. The questions must be answered with "yes" and "no" and "frequency". At the end there is a total score and a sports score, which can be divided into three different categories. The questionnaire to be filled out once a week.

10.3.4 VAS
all patients are interrogated by the VAS scale 3 times a day during the 4 weeks of trianing (1 hour, 5 hours, and 10 hours after getting up and before and after each workout)how the fatigue state is. Participation gutters cross this on a scale from 1 to 10 on their current state of mind.

Instead of movement diary, which should be filedl out additional from patients everyday, they can also (if enough available) get a Senseware band. This keeps track of important physiological parameters.

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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 / Senseware / movement diary = physical activity
Blood sample = BDNF, IL-6, TNF alpha, VEGF, IGF1, MIF

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/04/14
  •   125
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients with a history of malignancy (all entities)
Patients in the follow-up
Fatigue VAS 1-7
completed chemotherapy
Age> = 18 years
written and valid informed consent

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Exclusion Criteria

Fatigue Syndrome> 7;
Age> 75 years;
palliative patients with advanced cancer;
ongoing chemotherapy:
other diseases cause a fatigue;
more than three METS for a typical week (from Freiburg FB SHort version):
all disease situations that do not allow a sporting activity, in particular:
clinically overt cardiac failure (NYHA III-IV),
respiratory globally and partialinsuffizient,
persistent thrombocytopenia, congenital or acquired thrombocytopenia or any coagulation disorder;
unwillingness to storage and disclosure of personal health data in the context of the Protocol;
symptomatic coronary artery disease;
severe intractable hypertension;
not adjustable COPD;
uncontrolled cerebral seizures;
metastases;
Participation in another study sports;
medical or psychological condition that does not allow in the opinion of the investigator, that the patient participates in the study or gives a final signature of consent.

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Addresses

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    • deutsche Sporthochschule KölnAG " Bewegung, Sport und Krebs"
    • Mr.  Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • deutsche Sporthochschule KölnAG " Bewegung, Sport und Krebs"
    • Mr.  Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • deutsche Sporthochschule Köln
    • Mr.  Dr.  Freerk  Baumann 
    • am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln
    • 50933  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.