Strength Training For Therapy-Induced Muscle Weakness

描述（由申请人提供）： 癌症的治疗可能会产生有害的影响。化疗和生物疗法都有记录表明对骨骼肌有不良影响。癌症和治疗相关的副作用，如能量水平下降，肌肉无力和功能状态和体重下降已经有很好的记录。早期检测方法和新疗法延长了癌症患者的寿命，因此，癌症患者在疾病和治疗的影响下寿命更长。本研究的目的是测试I-IIIa期非转移性乳腺癌化疗患者坚持力量训练锻炼计划的有效性。 本研究的主要具体目的是确定力量训练运动计划对肌肉力量、疲劳、身体组成和生活质量随时间变化的影响，控制年龄、总药物剂量、研究地点和基线肌肉力量。第二个具体目标是确定家庭力量训练锻炼计划对患者和临床医生的可行性和可接受性。 本研究将使用两组随机临床试验，将招募128例（每组64例）接受化疗治疗的受试者的便利样本，并在基线和治疗4、8和12周时收集肌力、身体组成、疲劳水平和生活质量的数据。基线数据收集后，受试者将被随机分配到定制的力量训练干预组或对照组。干预组受试者将接受常规护理和家庭力量训练锻炼计划。对照组的参与者除了常规护理外，还将接受注意力干预。数据分析将使用ANCOVA和回归斜率比较组间差异，回归斜率计算为因变量随时间变化的评分。在方案完成时，将从干预组收集关于家庭力量训练运动计划的可行性和可接受性的问题。内容分析和定量数据将被用来确定一个家庭为基础的力量训练锻炼计划的可行性和可接受性的病人和临床医生。

DESCRIPTION (provided by applicant): Treatments for cancer can have deleterious effects. Both chemotherapy and biotherapy have documented ill effects on skeletal muscle. Cancer and treatment-related side effects such as decreased energy level, muscle weakness and declines in functional status and body mass have been well documented. Early detection methods and novel therapies have increased the life span of individuals living with cancer, and thus, individuals with cancer are living longer lives with the effects of disease and treatment. The purpose of this study is to test the effectiveness of adherence to a strength training exercise program in individuals undergoing chemotherapy for Stage I-IIIa non-metastatic breast cancer. The primary specific aim of this study is to determine the effect of a strength training exercise program on changes in muscle strength, fatigue, body composition and quality of life over time, controlling for age, total drug dose, research site, and baseline muscle strength. A secondary specific aim is to determine the feasibility and acceptability of a home-based strength training exercise program to patients and clinicians. A two group randomized clinical trial will be used for this study, a convenience sample of 128 (64 per group) subjects receiving treatment with chemotherapy will be recruited and data on muscle strength, body composition, fatigue levels and quality of life will be collected at baseline, and 4, 8 and 12 weeks of treatment. Following baseline data collection, subjects will be randomly assigned to the tailored strength training intervention or to the control group. Subjects in the intervention group will be given usual care plus a home strength training exercise program. Participants in the comparison group will receive an attentional intervention in addition to the usual care. Data analysis will compare group differences using ANCOVA and regression slopes calculated as scores of change over time for the dependent variables. Questions regarding the feasibility and acceptability of a home-based strength training exercise program will be collected from the intervention group at protocol completion. Content analysis and quantitative data will be used to determine the feasibility and acceptability of a home-based strength training exercise program to patients and clinicians.