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Klinische Studien

FatiGO-Studie

AcronymISRCTNEudraCTClinicaltrials.govDRKS
DRKS00007798

Immideat effects of targeted exercise on fatigue syndrome in cancer patients

Status: Active

Purpose / Objectives

Primary Outcome

The aim of this study is to evaluate the immediate efficacy of various targeted exercise interventions under supervision of fatigue syndrome.

Secondary Outcomes

Improving quality of life and mental well being

 

Improvement of the physical activity level

 

Which intervention group (strength or endurance training) and which exercise intensities have the best effects to reduce fatigue syndrome?

 

Development of Oncology Standard Training Therapy

Diagnosis

Patients with a malignant disease (all entities), located 1-5 years in aftercare

Patient attributes

Stage

TNM 1-3

Age

18-69

Inclusion criteria

Patients with malignant disease (all entities)

Patients in aftercare

Patients with existing fatigue syndrome (VAS 1-7)
 
Completion of medical therapy (chemotherapy and irradiation) at least 1 year, maximum 5 years

Written declaration of consent of the patient

Age ≥ = 18 years

Exclusion criteria

Fatigue Syndrome VAS > 7
Age > 69

Palliative patient therapy and patients with advanced cancer

Ongoing chemotherapy, ongoing irradiation

Diseases that cause fatigue

Medications that cause fatigue

Activity level > 3 met in a typical week (Fribourg FB short version)

All illness situations that do not allow for a sporting activity, in particular:

 

Clinical manifestation of heart failure (NYHA III-IV)

Respiratory partial or global insufficiency

Permanent thrombocytopenia < 10,000/Μ L, e.g. therapy refractory Autoimmunthrombozytopenia.

Congenital or acquired Thrombozytopathien or coagulation disorders.

Symptomatic CHD (IF. Implementation of stress ECG and cardiac ultrasound recommended)

 

Severe therapy refractory hypertension

Non-adjustable COPD
 
Uncontrolled cerebral cramping

 

Severe anemia

Medical or psychological condition which, in the opinion of the investigating physician, does not allow to participate in the study or to provide a valid signature of the Declaration of consent

Lack of willingness to store and transfer personal disease data under the protocol

Participating in another sports study

Trial design

  • Phase IV
  • Single center
  • Prospective
  • Randomized
  • Five-arm
  • Open Label

Intervention

Four weeks. 12 exercise sessions, 3 times/week (documentation of training, VAS, Borg (endurance), RPE (strength))

 

Arm1: Control group

 

Arm 2: Endurance training Moderate intensity
Warm up: 4 min; Endurance training, Selection: Crosswalker, bicycle ergometer.
Main training: 3 endurance exercise sessions per week. 30 min (Superviced), according to the permanent method 50-60% of VO2max

 

Arm 3: Strength training moderate intensity (50-60% maximum strength):
This group participates 3 times a week in a 30-minute strength training session (6 different exercises of three series with 20 repetitions each):

 

Warm up 4min; than:

 

1. Leg Stretcher
2. Bench press
3. Rowing
4. Abdominal exercise
5. Leg Flexors
6. Back Trainer

 

ARM 4: endurance, Vigorous exercise, 70-80% of VO2max:
Warm up: 4 min.; Endurance training, Selection: Crosswalker, bicycle ergometer,
Main training: 3 endurance training sessions per week. 30 min (Supervised), according to the permanent method 70-80% of VO2max:

 

Arm 5 strength training, hypertrophic (70-80% maximum strength):
 3 times a week , strength training of 30 minutes (6 different exercises of three series with each 8-12 repetitions):

 

Warm up 4min; Than:

 

1. Leg Stretcher
2. Bench press
3. Rowing
4. Abdominal exercise
5. Leg Flexors
6. Back Trainer

 

Duration of the motion program:
The intervention is carried out over a period of 4 weeks (3 times a week) and is supervidiert by qualified personnel.

Documents (password protected)

Responsibilities in overall trial

CIO ABCD

  • Tel. +49 (0) 221 - 478 87660, +49 228 287 16036
  • Fax +49 (0) 221 478 87713 ,+49 (0)228 287 16887

National Coordinating Investigator

PD Dr. Freerk T. Baumann

National Coordinating Investigator

PD Dr. med. Thomas Elter

Study Sites

Klinik I für Innere Medizin

Study office

  • AG Onkologische Bewegungsmedizin

    Status

    Active

    Principal Investigator

    PD Dr. Freerk T. Baumann

    Contact at Site

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