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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer patient after lumpectomy or mastectomy, stage I-III
- •adjuvant chemotherapy
- •BMI at least 18
排除标准
- •contraindication for exercise
- •radiotherapy during intervention period
研究组 & 干预措施
Resistance training
干预措施: Supervised progressive resistance training (Other)
Relaxation training
干预措施: Supervised progressive muscle relaxation training (Jacobsen method) (Other)
结局指标
主要结局
Fatigue measured by Fatigue Assessment Questionnaire (FAQ)
时间窗: change between baseline and week 13 (end of intervention)
次要结局
- 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))