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Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fatigue Mood Maximal Oxygen Uptake Behavioral: Exercise Behavioral: Cognitive behavioural therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue
Study Start Date : December 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cognitive behavioural therapy Behavioral: Cognitive behavioural therapy
Teaching of techniques to reduce fatigue and to improve stamina
Experimental: Exercise
Endurance training (walking on a treadmill) 3 x weekly for 4 weeks
Behavioral: Exercise
Endurance exercise 3 times weekly for 45 minutes, 4 weeks long



Primary Outcome Measures :
  1. Fatigue scores on the Brief Fatigue Inventory (BFI) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Maximal oxygen uptake (VO2max) on a treadmill stress test. [ Time Frame: 4 weeks ]
  2. Scores on the HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035203


Contacts
Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de

Locations
Germany
Department of Sports Medicine Recruiting
Berlin, Germany, 14167
Contact: Fernando Dimeo, MD    +493084452098    fernando.dimeo@charite.de   
Contact: Susanne Effenberger    +493084454834    susanne.effenberger@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany

Responsible Party: Fernando Dimeo, MD, Charité Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01035203     History of Changes
Other Study ID Numbers: 176-25/kmo
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms