Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Tokyo, Japan.
Faculty of Bioscience and Applied Chemistry, Hosei University, Koganei, Tokyo, Japan.
BMJ Open. 2019 Aug 22;9(8):e030911. doi: 10.1136/bmjopen-2019-030911.
Maintaining high levels of physical activity helps to maintain and improve physical health and quality of life, and plays a role in reducing adverse effects due to cancer treatments. Moreover, a greater degree of cardiorespiratory fitness is associated with reduced risk of all-cause mortality. However, there are no home-based programme for improving cardiorespiratory fitness using body weight exercises for breast cancer survivors. This study will assess the efficacy of the newly developed habit-B programme on maximum oxygen uptake compared with treatment as usual with wearable device. The effects of this programme on exercise habits, level of physical activity, physical fitness and subjective indices will also be investigated.
This is a 12-week, parallel-group, single-blind, randomised controlled trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be assigned to the habit-B programme (high-intensity interval training, exercise counselling + guidance, home-based exercise support using information and communication technology, and a wearable device) or treatment as usual with a wearable device. Subjects will be sedentary women aged 20-59 years who have received breast surgery in the past 2-13 months after the diagnosis of invasive breast cancer (stages I-IIa) and have never received chemotherapy except for hormone therapy. The primary endpoint is the change in peak oxygen uptake (VO; mL/kg/min) between the groups after 12 weeks of intervention.
The study protocol was approved by the Institutional Review Board of the National Cancer Center Japan on 28 February 2019 (ID: 2018-347). The findings will be disseminated through peer-reviewed publications and conference presentations.
UMIN000036400.
保持高水平的身体活动有助于维持和改善身体健康和生活质量，并可减少癌症治疗的不良反应。此外，更高程度的心肺健康与全因死亡率降低相关。然而，对于乳腺癌幸存者，目前尚无使用体重锻炼来提高心肺健康的家庭计划。本研究将评估新开发的习惯-B 计划在使用可穿戴设备的最大摄氧量方面与常规治疗相比的疗效。还将研究该计划对运动习惯、身体活动水平、身体健康和主观指标的影响。
这是一项为期 12 周、平行组、单盲、随机对照试验。将通过中央服务器使用独立数据中心提供的计算机生成的随机分配序列进行分配。参与者将被分配到习惯-B 计划（高强度间歇训练、运动咨询+指导、使用信息和通信技术的家庭锻炼支持以及可穿戴设备）或仅使用可穿戴设备的常规治疗。研究对象将是年龄在 20-59 岁之间的久坐女性，她们在诊断为浸润性乳腺癌（I 期-IIa 期）后 2-13 个月内接受过乳房手术，且除激素治疗外从未接受过化疗。主要终点是干预 12 周后两组间峰值摄氧量（VO；mL/kg/min）的变化。
该研究方案于 2019 年 2 月 28 日获得日本国家癌症中心机构审查委员会的批准（ID：2018-347）。研究结果将通过同行评议的出版物和会议报告进行传播。
UMIN000036400。
