Text Size

Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01035203
First received: December 17, 2009
Last updated: March 29, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Fatigue
Mood
Maximal Oxygen Uptake
 Behavioral: Exercise
Behavioral: Cognitive behavioural therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Fatigue scores on the Brief Fatigue Inventory (BFI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal oxygen uptake (VO2max) on a treadmill stress test. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Scores on the HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Fernando Dimeo, MD, Charité Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01035203     History of Changes
Other Study ID Numbers: 176-25/kmo
Study First Received: December 17, 2009
Last Updated: March 29, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013