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Effects of progressive upper limb exercises and muscle relaxation training on upper limb function and health-related quality of life following surgery in women with breast cancer: a clinical randomized controlled trial
Zhou K, Wang W, An J, Li M, Li J, Li X
Annals of Surgical Oncology 2019 Jul;26(7):2156-2165
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: The aim of this study was to examine the effects of progressive upper limb exercises and muscle relaxation training (PULE-MRT) on upper limb function and health-related quality of life (HRQoL) following surgery in Chinese mainland women with breast cancer (BC). METHODS: Overall, 102 patients following surgery (ie, mastectomy or breast-conserving surgery, with sentinel lymph node biopsy or axillary lymph node dissection) were randomly allocated to the intervention (n = 51) or control (n = 51) groups. The former received PULE-MRT plus routine nursing care, whereas the latter received only routine nursing care for 6 months. Upper limb function and HRQoL were measured at baseline and 1, 3, and 6 months using Constant-Murley scores (CMS) and Functional Assessment of Cancer Therapy-Breast version 4.0 (FACT-Bv4.0), respectively. RESULTS: All patients in the intervention group completed the exercises and training, with 100% compliance and no adverse events. The intervention group had significantly higher total CMS and FACT-Bv4.0 scores at 1-, 3-, and 6-month follow-up than the control group. The significant effects in total CMS comparisons were group (F 25.30, p < 0.001), time (F 18.02, p < 0.001), and group-by-time interaction (F 9.95, p < 0.001), and, in FACT-Bv4.0, total score comparisons were group (F 15.87, p < 0.001), time (F 17.92, p < 0.001), and group-by-time interaction (F 7.88, p < 0.001). Similar results were observed for the scale scores of CMS and FACT-Bv4.0. CONCLUSIONS: PULE-MRT had positive effects on improving upper limb function and HRQoL following surgery in women with BC and could be used as an optional rehabilitation management strategy in post-surgery BC patient populations. TRIAL REGISTRATION: ChiCTR-IOR-16008253 (chr.org.cn; 9 April 2016).
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