Effect of early exercise on functional recovery and surgical outcomes after post-mastectomy breast reconstruction: study protocol for a randomized clinical trial

Abstract

Background Although mastectomy and reconstruction have a positive impact on breast cancer patients' quality of life, postoperative side effects such as shoulder functional limitations and pain are common. To reduce these side effects, the importance of early postoperative exercise has been emphasized, and the need for tailored exercise programs is emerging. Therefore, this randomized controlled trial (RCT) aims to investigate the impact of a tailored early exercise program based on patient symptoms and timing on shoulder and trunk function and health-related outcomes in breast cancer patients who received immediate breast reconstruction. Methods This pragmatic, two-armed RCT will involve 72 breast cancer patients undergoing immediate breast reconstruction following total mastectomy. Participants will be randomized to either the exercise or control group (36 in the exercise group and 36 in the control group). During the 6-month period, participants in the exercise group will receive a tailored exercise program based on their symptoms over time, treatment stage, and physical function. The exercise intervention will last for a total of 6 months and will be conducted in two ways. Participants will be encouraged to attend one supervised exercise session per week for the first month following surgery (total of four sessions), after which they will be encouraged to switch to home-based exercise and perform 150 minutes of moderate-intensity aerobic exercise and at least 2 resistance exercises per week. The primary outcome is shoulder and trunk function (range of motion [ROM] and strength), with secondary and tertiary outcomes including patient-reported outcomes, body composition, and physical activity levels. Shoulder and trunk function will be measured at postoperative day (POD) 1 (baseline), postoperative day POD5, POD10-14, postoperative 1 month, postoperative 3 months, and postoperative 6 months, while the other outcomes will be measured at the same time points except for POD5. Conclusion This study is a tailored exercise oncology trial to better understand the short- and long-term effects of exercise on shoulder and trunk function and other health-related outcomes after mastectomy and reconstruction in breast cancer patients. The results of this study may prove valuable in providing important insights into the role of exercise in postoperative breast cancer patients and help develop effective exercise programs tailored to their needs. Trial registration The study protocol for this study is registered with the National Clinical Trials Registry (NCT06552650; first posted on April 30, 2024).