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Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life (BEATE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106820
First Posted: April 20, 2010
Last Update Posted: December 19, 2016
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.
Collaborators:
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
Information provided by (Responsible Party):
German Cancer Research Center
April 14, 2010
April 20, 2010
December 19, 2016
April 2010
October 2013   (Final data collection date for primary outcome measure)
Fatigue measured by Fatigue Assessment Questionnaire (FAQ) [ Time Frame: change between baseline and week 13 (end of intervention) ]
Same as current
Complete list of historical versions of study NCT01106820 on ClinicalTrials.gov Archive Site
  • Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23) [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Muscle strength measured at the IsoMed2000® [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Cardiorespiratory fitness measured by ergospirometry [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Biomarker in blood, urine, and saliva [ Time Frame: change between baseline and week 6 and 13 ]
  • Number of patients with adverse events potentially related to the resistance training [ Time Frame: during the 12-week exercise intervention ]
  • Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23) [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Muscle strength measured at the IsoMed2000® [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Cardiorespiratory fitness measured by ergospirometry [ Time Frame: change between baseline and week 13 (end of intervention) ]
  • Biomarker in blood, urine, and saliva [ Time Frame: change between baseline and week 6 and 13 ]
  • Safety of resistance training during chemotherapy [ Time Frame: during intervention ]
Not Provided
Not Provided
 
Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life
Progressive Resistance Training vs. Relaxation for Breast Cancer Patients During Chemotherapy: A Randomized Controlled Intervention Trial to Evaluate the Biological Mechanisms and Effects of Resistance Training on Fatigue and Quality of Life
The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and quality of life in breast cancer patients during chemotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Breast Cancer
  • Cancer-related Fatigue
  • Other: Supervised progressive resistance training
    Supervised progressive resistance training
  • Other: Supervised progressive muscle relaxation training (Jacobsen method)
    Supervised progressive muscle relaxation training (Jacobsen method)
  • Active Comparator: Resistance training
    Intervention: Other: Supervised progressive resistance training
  • Active Comparator: Relaxation training
    Intervention: Other: Supervised progressive muscle relaxation training (Jacobsen method)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
October 2014
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • breast cancer patient after lumpectomy or mastectomy, stage I-III
  • adjuvant chemotherapy
  • BMI at least 18

Exclusion Criteria:

  • contraindication for exercise
  • radiotherapy during intervention period
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01106820
BEATE-1
No
Not Provided
Not Provided
German Cancer Research Center
German Cancer Research Center
  • National Center for Tumor Diseases, Heidelberg
  • University Hospital Heidelberg
  • Central Institute of Mental Health, Mannheim
Principal Investigator: Karen Steindorf, Prof. Dr. NCT Heidelberg
German Cancer Research Center
December 2016

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