Effect of home-based high-intensity interval training and behavioural modification using information and communication technology on cardiorespiratory fitness and exercise habits among sedentary breast cancer survivors: habit-B study protocol for a randomised controlled trial.

Introduction: 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.

Methods And Analysis: 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.

Ethics And Dissemination: 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.

Trial Registration Number: UMIN000036400.