BACKGROUND: This study assessed the impact that free range-of-motion (ROM) upper limb exercises 15 or 30 days after mastectomy and immediate implant-based reconstruction has on surgical complications and kinetic-functional recovery. METHODS: This randomized clinical trial included 60 women who had breast cancer treated withmastectomy and immediate implant or tissue expander reconstruction. The patients initiated the exercises with shoulder ROM limited to 90° the day after surgery. After 2 weeks, the patients were randomized into two groups of 30 patients each: the "free-range group," which permitted shoulder range exercises until limited by pain or wound dehiscence, and the "limited-range group," which maintained shoulder movement restriction at 90° until 30 days after surgery, at which time they also were allowed to perform free-range exercises. The patients underwent evaluations preoperatively, then 7, 15, 30, 60, and 90 days after surgery. The primary outcomes were incidence and prevalence of dehiscence and seroma and incidence of infection and necrosis. The secondary outcomes were shoulder ROM, pain, and upper limb function. RESULTS: The two groups did not differ in terms of incidence and prevalence of postoperative complications. The patients with free upper limb exercise 15 days after surgery had less pain, greater shoulder amplitude, and better upper limb function than those who had movement restricted to 90° for 30 days. CONCLUSION: The postoperative protocol with free shoulder ROM on the 15th day after surgery is safe and beneficial in terms of kinetic-functional recovery and pain control for patients after mastectomy and immediate implant-based reconstruction. CLINICAL TRIALS REGISTER: NCT02480842.
RCT Entities:
BACKGROUND: This study assessed the impact that free range-of-motion (ROM) upper limb exercises 15 or 30 days after mastectomy and immediate implant-based reconstruction has on surgical complications and kinetic-functional recovery. METHODS: This randomized clinical trial included 60 women who had breast cancer treated with mastectomy and immediate implant or tissue expander reconstruction. The patients initiated the exercises with shoulder ROM limited to 90° the day after surgery. After 2 weeks, the patients were randomized into two groups of 30 patients each: the "free-range group," which permitted shoulder range exercises until limited by pain or wound dehiscence, and the "limited-range group," which maintained shoulder movement restriction at 90° until 30 days after surgery, at which time they also were allowed to perform free-range exercises. The patients underwent evaluations preoperatively, then 7, 15, 30, 60, and 90 days after surgery. The primary outcomes were incidence and prevalence of dehiscence and seroma and incidence of infection and necrosis. The secondary outcomes were shoulder ROM, pain, and upper limb function. RESULTS: The two groups did not differ in terms of incidence and prevalence of postoperative complications. The patients with free upper limb exercise 15 days after surgery had less pain, greater shoulder amplitude, and better upper limb function than those who had movement restricted to 90° for 30 days. CONCLUSION: The postoperative protocol with free shoulder ROM on the 15th day after surgery is safe and beneficial in terms of kinetic-functional recovery and pain control for patients after mastectomy and immediate implant-based reconstruction. CLINICAL TRIALS REGISTER: NCT02480842.