Berntsen Sveinung, Aaronson Neil K, Buffart Laurien, Börjeson Sussanne, Demmelmaier Ingrid, Hellbom Maria, Hojman Pernille, Igelström Helena, Johansson Birgitta, Pingel Ronnie, Raastad Truls, Velikova Galina, Åsenlöf Pernilla, Nordin Karin
Dept. of Public Health and Caring Sciences, Lifestyle and rehabilitation in long term illness, Uppsala University, Box 564, 75122, Uppsala, Sweden.
Dept. of Public Health, Sport and Nutrition, University of Agder, Gimlemoen 25, 4604, Kristiansand, Norway.
BMC Cancer. 2017 Mar 27;17(1):218. doi: 10.1186/s12885-017-3197-5.
Cancer-related fatigue is a common problem in persons with cancer, influencing health-related quality of life and causing a considerable challenge to society. Current evidence supports the beneficial effects of physical exercise in reducing fatigue, but the results across studies are not consistent, especially in terms of exercise intensity. It is also unclear whether use of behaviour change techniques can further increase exercise adherence and maintain physical activity behaviour. This study will investigate whether exercise intensity affects fatigue and health related quality of life in persons undergoing adjuvant cancer treatment. In addition, to examine effects of exercise intensity on mood disturbance, adherence to oncological treatment, adverse effects from treatment, activities of daily living after treatment completion and return to work, and behaviour change techniques effect on exercise adherence. We will also investigate whether exercise intensity influences inflammatory markers and cytokines, and whether gene expressions following training serve as mediators for the effects of exercise on fatigue and health related quality of life.
METHODS/DESIGN: Six hundred newly diagnosed persons with breast, colorectal or prostate cancer undergoing adjuvant therapy will be randomized in a 2 × 2 factorial design to following conditions; A) individually tailored low-to-moderate intensity exercise with or without behaviour change techniques or B) individually tailored high intensity exercise with or without behaviour change techniques. The training consists of both resistance and endurance exercise sessions under the guidance of trained coaches. The primary outcomes, fatigue and health related quality of life, are measured by self-reports. Secondary outcomes include fitness, mood disturbance, adherence to the cancer treatment, adverse effects, return to activities of daily living after completed treatment, return to work as well as inflammatory markers, cytokines and gene expression.
The study will contribute to our understanding of the value of exercise and exercise intensity in reducing fatigue and improving health related quality of life and, potentially, clinical outcomes. The value of behaviour change techniques in terms of adherence to and maintenance of physical exercise behaviour in persons with cancer will be evaluated.
NCT02473003 , October, 2014.
癌症相关疲劳是癌症患者的常见问题，影响与健康相关的生活质量，并给社会带来巨大挑战。目前的证据支持体育锻炼对减轻疲劳的有益作用，但各研究结果并不一致，尤其是在运动强度方面。行为改变技术的使用是否能进一步提高运动依从性并维持身体活动行为也尚不清楚。本研究将调查运动强度是否会影响接受辅助癌症治疗患者的疲劳和与健康相关的生活质量。此外，研究运动强度对情绪障碍、肿瘤治疗依从性、治疗不良反应、治疗完成后的日常生活活动及恢复工作的影响，以及行为改变技术对运动依从性的影响。我们还将研究运动强度是否会影响炎症标志物和细胞因子，以及训练后的基因表达是否作为运动对疲劳和与健康相关生活质量影响的中介。
方法/设计：600名新诊断的接受辅助治疗的乳腺癌、结直肠癌或前列腺癌患者将按2×2析因设计随机分为以下几组：A）有或无行为改变技术的个体化低至中等强度运动；或B）有或无行为改变技术的个体化高强度运动。训练包括在训练有素的教练指导下进行的抗阻和耐力训练课程。主要结局指标疲劳和与健康相关的生活质量通过自我报告进行测量。次要结局指标包括体能、情绪障碍、癌症治疗依从性、不良反应、治疗完成后恢复日常生活活动、恢复工作以及炎症标志物、细胞因子和基因表达。
本研究将有助于我们理解运动及运动强度在减轻疲劳、改善与健康相关的生活质量以及潜在临床结局方面的价值。将评估行为改变技术在癌症患者坚持和维持体育锻炼行为方面的价值。
NCT02473003，2014年10月。
