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

Not Applicable

Completed

• Conditions: Cancer-related Fatigue; Breast Cancer
• Interventions: Other: Supervised progressive muscle relaxation training (Jacobsen method); Other: Supervised progressive resistance training

• Registration Number: NCT01106820
• Lead Sponsor: German Cancer Research Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2013-10
• Study Completion: 2014-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

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

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Exclusion Criteria

• contraindication for exercise
• radiotherapy during intervention period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation training	Supervised progressive muscle relaxation training (Jacobsen method)	-
Resistance training	Supervised progressive resistance training	-

Primary Outcome Measures

Name	Time	Method
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)	change between baseline and week 13 (end of intervention)

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events potentially related to the resistance training	during the 12-week exercise intervention
Depression measured by "Allgemeine Depressionsskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D))	change between baseline and week 13 (end of intervention)
Muscle strength measured at the IsoMed2000®	change between baseline and week 13 (end of intervention)
Biomarker in blood, urine, and saliva	change between baseline and week 6 and 13
Cardiorespiratory fitness measured by ergospirometry	change between baseline and week 13 (end of intervention)
Quality of Life measured by the European Organisation for Research and Treatment of Cancer questionnaire (EORTC-QLQ30/BR23)	change between baseline and week 13 (end of intervention)

Trial Locations

Locations (1)

German Cancer Research Center; 🇩🇪 Heidelberg, Germany