ABSTRACT

To assess the effects of a group class physical exercise program on health-related quality of life (HRQOL), physical fitness and activity, and safety in early breast cancer women after treatment, a double-phase trial [16-week control phase (CP) followed by a 16-week intervention phase (IP)] was designed. Outcomes were evaluated at baseline (T1), 8 (T2) and 16 (T3) weeks (CP), and 24 (T4) and 32 (T5) weeks (IP). The primary endpoint was global health status. Out of 82 enrolled patients, 37 completed the IP. Global health status decreased (−10,1; 95% CI −19.8 to −0.4; p = 0.040) during the CP and stabilized during the IP. Physical and sexual functioning increased during the IP (p = 0.008; p = 0.017), while cardiorespiratory fitness increased in the CP (p = 0.004). Upper limb strength and lower limb functionality increased during both phases [CP: p < 0.0001, p = 0.001 (surgical and nonsurgical arm), p = 0.028; IP: p < 0.0001, p = 0.002, p = 0.009]. Body mass index decreased in the IP (p = 0.026). Waist circumference increased in the CP (p = 0.001) and decreased in the IP (p = 0.010); sedentary behaviours and moderate and vigorous physical activity did not change. Adherence to 70% of the sessions was reported in 54% of patients. No serious adverse events related to the intervention were reported. In conclusion, the physical exercise program was able to prevent the decline in global health status and to improve other domains of HRQOL and physical fitness. As physical exercise is not the standard of care in many countries, the implementation of group class programs might be an option.

摘要

为了评估团体课程体育锻炼计划对治疗后早期乳腺癌女性的健康相关生活质量 (HRQOL)、体能和活动以及安全性的影响，开展了一项双阶段试验 [16 周对照阶段 (CP) ）随后设计了为期 16 周的干预阶段（IP）。在基线 (T1)、8 (T2) 和 16 (T3) 周 (CP) 以及 24 (T4) 和 32 (T5) 周 (IP) 时评估结果。主要终点是全球健康状况。在 82 名登记患者中，37 名完成了 IP。 CP 期间总体健康状况下降（−10,1；95% CI -19.8 至 -0.4；p = 0.040），IP 期间稳定。IP 期间身体和性功能得到改善（p  = 0.008；p  = 0.017），而 CP 期间心肺健康得到改善（p  = 0.004）。上肢力量和下肢功能在两个阶段均有所增加 [CP：p  < 0.0001，p  = 0.001（手术和非手术臂），p  = 0.028；IP：p  < 0.0001，p  = 0.002，p  = 0.009]。IP 中的体重指数下降 ( p  = 0.026)。CP 中腰围增加（p  = 0.001），IP 中腰围减小（p  = 0.010）；久坐行为以及适度和剧烈的体力活动没有改变。据报告，54% 的患者坚持了 70% 的疗程。没有报告与干预相关的严重不良事件。总之，体育锻炼计划能够防止全球健康状况下降，并改善 HRQOL 和身体素质的其他领域。由于体育锻炼在许多国家不是护理标准，因此实施团体课程计划可能是一种选择。