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| Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial |
| Heiman J, Onerup A, Wessman C, Haglind E, Olofsson Bagge R |
| The British Journal of Surgery 2021 Jan;108(1):32-39 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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* |
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BACKGROUND: The effect of preoperative physical activity on recovery and complications after primary breast cancer surgery is unknown. The objective of this trial was to evaluate whether a recommendation of non-supervised physical activity improved recovery after breast cancer surgery. METHODS: This parallel, unblinded, multicentre interventional trial randomized women in whom breast cancer surgery was planned. The intervention consisted of an individual recommendation of added aerobic physical activity (30 min/day), before and 4 weeks after surgery. The control group did not receive any advice regarding physical activity. The primary outcome was patient-reported physical recovery at 4 weeks after surgery. Secondary outcomes included mental recovery, complications, reoperations, and readmissions. RESULTS: Between November 2016 and December 2018, 400 patients were randomized, 200 to each group. Some 370 participants (180 intervention, 190 control) remained at 4 weeks, and 368 at 90 days. There was no significant difference in favour of the intervention for the primary outcome physical recovery (risk ratio (RR) 1.03, 95% CI 0.95 to 1.13). There was also no difference for mental recovery (RR 1.05, 0.93 to 1.17) nor in mean Comprehensive Complication Index score (4.2 (range 0 to 57.5) versus 4.7 (0 to 58.3)) between the intervention and control groups. CONCLUSION: An intervention with recommended non-supervised physical activity before and after breast cancer surgery did not improve recovery at 4 weeks after surgery. REGISTRATION NUMBER: NCT02560662 (http://www.ClinicalTrials.gov).
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