Trial document
DRKS00007798
Trial Description
Title
Prospective, randomized, controlled study to evaluate the direct effect of specific movement therapy with professional supervision by various Inteventionen on the Fatigue Syndrome
Trial Acronym
FatiGo-Study
URL of the Trial
https://cio.uk-koeln.de/leben-mit-krebs/bewegung/studien-und-publikationen/
Brief Summary in Lay Language
The Fatigo study should investigate the immediate effectiveness of supervised and targeted exercise therapy on the Fatigue Syndrome.
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.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00007798
- 2015/05/05
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- yes
- Approved
- 17-157, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
Secondary IDs
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Health Condition or Problem studied
- F48 - Other neurotic disorders
- Fatigue
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 )
Characteristics
- Interventional
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- 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
Primary Outcome
Evaluation of the immediate effectiveness of targeted exercise therapy with professional supervision through various interventions on the fatigue syndrome (MFI20).
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
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- University Medical Center
- University Medical Center
Recruitment
- Actual
- 2019/11/17
- 125
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 69 Years
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
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
Addresses
-
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- Uniklinik Köln - CIO
- Kerpener Straße 62 Uniklinik Köln / Gebäude 70
- 50937 Köln
- Germany
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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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- ma.sinn at uke.de
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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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- Loeffler_C at ukw.de
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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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- ott at uk-koeln.de
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- Uniklinik Köln - CIO - OTT
- Kerpener Straße 62 Uniklinik Köln / Gebäude 70
- 50937 Köln
- Germany
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- ott at uk-koeln.de
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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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