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。化疗和生物治疗都证明了对骨骼肌的不良影响。癌症和治疗相关的副作用，如能量水平下降，肌肉无力，功能状态和身体质量下降，都有很好的记录。早期的检测方法和新的治疗方法延长了癌症患者的寿命，因此，由于疾病和治疗的影响，癌症患者的寿命更长。这项研究的目的是测试在接受I-IIIa期非转移性乳腺癌化疗的患者中坚持力量训练锻炼计划的有效性。 这项研究的主要具体目的是确定力量训练锻炼计划对肌肉力量、疲劳、身体成分和生活质量随时间的变化的影响，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以家庭为基础的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。 本研究将采用两组随机临床试验，随机抽取128名接受化疗的受试者(每组)，收集基线、治疗4周、8周和12周的肌肉力量、身体成分、疲劳程度和生活质量的数据。在基线数据收集之后，受试者将被随机分配到量身定制的力量训练干预或对照组。干预组的受试者将得到常规护理，外加家庭力量训练锻炼计划。对照组的参与者将在常规护理的基础上接受注意干预。数据分析将使用ANCOVA和回归斜率来比较组内差异，回归斜率计算为因变量随时间变化的分数。有关家庭力量训练计划的可行性和可接受性的问题将在方案完成时从干预组收集。内容分析和定量数据将被用来确定患者和临床医生接受家庭力量训练锻炼计划的可行性和可接受性。

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.