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The RESTORE randomized controlled trial: impact of a multidisciplinary rehabilitative program on cardiorespiratory fitness in esophagogastric cancer survivorship
O'Neill LM, Guinan E, Doyle SL, Bennett AE, Murphy C, Elliott JA, O'Sullivan J, Reynolds JV, Hussey J
Annals of Surgery 2018 Nov;268(5):747-755
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; 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 Rehabilitation Strategies in Esophagogastric cancer (RESTORE) randomized controlled trial evaluated the efficacy of a 12-week multidisciplinary program to increase the cardiorespiratory fitness and health-related quality of life (HRQOL) of esophagogastric cancer survivors. BACKGROUND: Patients following treatment for esophagogastric cancer are at risk of physical deconditioning, nutritional compromise, and sarcopenia. Accordingly, compelling rationale exists to target these impairments in recovery. METHODS: Disease-free patients treated for esophagogastric cancer were randomized to either usual care or the 12-week RESTORE program (exercise training, dietary counseling, and multidisciplinary education). The primary outcome was cardiopulmonary exercise testing (VO2peak). Secondary outcomes included body composition (bioimpedance analysis), and HRQOL (EORTC-QLQ-C30). Outcomes were assessed at baseline (T0), postintervention (T1), and at 3-month follow-up (T2). RESULTS: Twenty-two participants were randomized to the control group (mean (standard deviation) age 64.14 (10.46) yr, body mass index 25.67 (4.83) kg/m2, time postsurgery 33.68 (19.56) mo), and 21 to the intervention group (age 67.19 (7.49) yr, body mass index 25.69 (4.02) kg/m, time postsurgery 23.52 (15.23) mo). Mean adherence to prescribed exercise sessions were 94% (12) (supervised) and 78% (27) (unsupervised). Correcting for baseline VO2peak, the intervention arm had significantly higher VO2peak at both T1, 22.20 (4.35) versus 21.41 (4.49) mL/min/kg, p < 0.001, and T2, 21.75 (4.27) versus 20.74 (4.65) mL/min/kg, p = 0.001, compared with the control group. Correcting for baseline values, no changes in body composition or HRQOL were observed. CONCLUSIONS: The RESTORE program significantly improved cardiorespiratory fitness of disease-free patients after esophagogastric cancer surgery, without compromise to body composition. This randomized controlled trial provides proof of principle for rehabilitation programs in esophagogastric cancer. CLINICAL TRIAL REGISTRATION NUMBER: NCT03314311.
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