Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035203
Recruitment Status : Unknown
Verified March 2010 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : December 18, 2009
Last Update Posted : March 30, 2010
Information provided by:
Charite University, Berlin, Germany

December 17, 2009
December 18, 2009
March 30, 2010
December 2009
July 2010   (Final data collection date for primary outcome measure)
Fatigue scores on the Brief Fatigue Inventory (BFI) [ Time Frame: 4 weeks ]
Fatigue [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT01035203 on Archive Site
  • Maximal oxygen uptake (VO2max) on a treadmill stress test. [ Time Frame: 4 weeks ]
  • Scores on the HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 4 weeks ]
  • Physical performance [ Time Frame: 4 weeks ]
  • Mood [ Time Frame: 4 weeks ]
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Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue
Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue
The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
  • Fatigue
  • Mood
  • Maximal Oxygen Uptake
  • Behavioral: Exercise
    Endurance exercise 3 times weekly for 45 minutes, 4 weeks long
  • Behavioral: Cognitive behavioural therapy
    Teaching of techniques to reduce fatigue and to improve stamina
  • Active Comparator: Cognitive behavioural therapy
    Intervention: Behavioral: Cognitive behavioural therapy
  • Experimental: Exercise
    Endurance training (walking on a treadmill) 3 x weekly for 4 weeks
    Intervention: Behavioral: Exercise
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-70
  • Histologically confirmed neoplastic disease
  • Treatment (chemotherapy or radiation) completed.
  • No treatment in the previous 4 weeks
  • Ability to understand written German

Exclusion Criteria:

  • Health conditions which can be aggravated by exercise
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Not Provided
Fernando Dimeo, MD, Charité Universitätsmedizin Berlin
Charite University, Berlin, Germany
Not Provided
Not Provided
Charite University, Berlin, Germany
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP