RESTORE 随机对照试验：多学科康复方案对食管胃交界癌生存者心肺适能的影响。

The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship.

机构信息

Discipline of Physiotherapy, School of Medicine, Trinity College Dublin, Dublin, Ireland.

School of Medicine, Trinity College Dublin, Dublin, Ireland.

出版信息

Ann Surg. 2018 Nov;268(5):747-755. doi: 10.1097/SLA.0000000000002895.

DOI:10.1097/SLA.0000000000002895

PMID:30004915

Abstract

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/m, 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.

摘要

目的

食管胃结合部癌的康复策略（RESTORE）随机对照试验评估了 12 周多学科方案对增加食管胃结合部癌幸存者的心肺功能适应性和健康相关生活质量（HRQOL）的疗效。

背景

接受食管胃结合部癌治疗的患者存在身体适应不良、营养受损和肌肉减少症的风险。因此，针对这些康复方面的缺陷具有很强的理由。

方法

无疾病的接受食管胃结合部癌治疗的患者被随机分配至常规护理或 12 周的 RESTORE 方案（运动训练、饮食咨询和多学科教育）。主要结局为心肺运动测试（VO2peak）。次要结局包括身体成分（生物阻抗分析）和 HRQOL（EORTC-QLQ-C30）。在基线（T0）、干预后（T1）和 3 个月随访（T2）时评估结局。

结果

22 名参与者被随机分配至对照组[平均（标准差）年龄 64.14（10.46）岁，体重指数 25.67（4.83）kg/m，手术后时间 33.68（19.56）个月]，21 名参与者被随机分配至干预组[年龄 67.19（7.49）岁，体重指数 25.69（4.02）kg/m，手术后时间 23.52（15.23）个月]。规定运动课程的依从率平均为 94（12）%（监督）和 78（27）%（非监督）。校正 VO2peak 的基线值后，干预组在 T1 时的 VO2peak 显著更高，分别为 22.20（4.35）与 21.41（4.49）mL/min/kg，P<0.001，T2 时为 21.75（4.27）与 20.74（4.65）mL/min/kg，P=0.001，与对照组相比。校正基线值后，未观察到身体成分或 HRQOL 的变化。