研究动态
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具有高心血管风险的癌症幸存者的心脏肿瘤康复:一项随机临床试验。

Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial.

发表日期:2023 Oct 11
作者: Sofia Gonçalves Viamonte, Ana Vieira Joaquim, Alberto Jorge Alves, Eduardo Vilela, Andreia Capela, Cristina Ferreira, Barbara Fresco Duarte, Nuno Dias Rato, Madalena Pinheiro Teixeira, Aida Tavares, Mário Santos, Fernando Ribeiro
来源: JAMA Cardiology

摘要:

心血管疾病是癌症幸存者发病的主要原因,这使得旨在降低心血管风险的策略成为当代重要的主题。 评估以中心为基础的心脏康复 (CBCR) 框架是否与包括社区运动训练在内的常规护理相比较(CBET) 对于具有高心血管风险的癌症幸存者的心肺健康改善和心血管危险因素控制效果更佳。这项前瞻性、单中心、随机临床试验(CORE 试验)包括接受过心脏毒性癌症治疗和/或既往有心血管疾病。入组时间为2021年3月1日至2022年3月31日。在基线和8周干预后评估终点。参与者以1:1的比例随机分配至8周的CBCR或CBET。有氧运动和抗阻运动相结合,每周进行两次。主要疗效指标是 2 个月时峰值耗氧量 (V̇o2) 的变化。次要结果包括握力最大力量、功能表现、血压(BP)、身体成分、体重指数(BMI;计算方法为体重(千克)除以身高(米)平方)、血脂、血浆生物标志物水平、体力活动(PA)水平、心理困扰、生活质量 (QOL) 和健康素养。共有 75 名参与者完成了这项研究(平均 [SD] 年龄,53.6 [12.3] 岁;58 名 [77.3%] 女性),其中 38 名参加了 CBCR组和 CBET 组 37 人。 CBCR 参与者的峰值 V̇o2 平均 (SD) 增幅高于 CBET 参与者(2.1 [2.8] mL/kg/min vs 0.8 [2.5] mL/kg/min),组间平均差异为 1.3 mL /kg/min(95% CI,0.1-2.6 mL/kg/min;P = .03)。与 CBET 组相比,CBCR 组的收缩压(-12.3 [11.8] mm Hg vs -1.9 [12.9] mm Hg;P < .001)、舒张压(-5.0 [ 5.7] mm Hg 对比 -0.5 [7.0] mm Hg;P = .003)和 BMI(-1.2 [0.9] 对比 0.2 [0.7];P < .001)以及 PA 水平的平均 (SD) 改善更大 (1035.2 [735.7] 代谢当量 [METs]/分钟/周 vs 34.1 [424.4] METs/分钟/周;P < .001),QOL(14.0 [10.0] 分 vs 0.4 [12.9] 分;P < .001),以及健康素养得分(2.7 [1.6] 分 vs 0.1 [1.4] 分;P < .001)。 CBCR 组的运动依从性显着高于 CBET 组(完成的平均 [SD] 疗程,90.3% [11.8%] vs 68.4% [22.1%];P < .001)。CORE 试验表明,有氧运动与社区环境中包含运动干预的常规护理相比,具有高心血管风险的癌症幸存者的肿瘤康复模式与峰值 V̇o2 的更大改善相关。 CBCR 在运动依从性、心血管危险因素控制、生活质量和健康素养方面也显示出优异的结果。ClinicalTrials.gov 标识符:NCT05132998。
Cardiovascular disease is a leading cause of morbidity in cancer survivors, which makes strategies aimed at mitigating cardiovascular risk a subject of major contemporary importance.To assess whether a center-based cardiac rehabilitation (CBCR) framework compared with usual care encompassing community-based exercise training (CBET) is superior for cardiorespiratory fitness improvement and cardiovascular risk factor control among cancer survivors with high cardiovascular risk.This prospective, single-center, randomized clinical trial (CORE trial) included adult cancer survivors who had exposure to cardiotoxic cancer treatment and/or previous cardiovascular disease. Enrollment took place from March 1, 2021, to March 31, 2022. End points were assessed at baseline and after the 8-week intervention.Participants were randomly assigned in a 1:1 ratio to 8 weeks of CBCR or CBET. The combined aerobic and resistance exercise sessions were performed twice a week.The powered primary efficacy measure was change in peak oxygen consumption (V̇o2) at 2 months. Secondary outcomes included handgrip maximal strength, functional performance, blood pressure (BP), body composition, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), lipid profile, plasma biomarker levels, physical activity (PA) levels, psychological distress, quality of life (QOL), and health literacy.A total of 75 participants completed the study (mean [SD] age, 53.6 [12.3] years; 58 [77.3%] female), with 38 in the CBCR group and 37 in the CBET group. Participants in CBCR achieved a greater mean (SD) increase in peak V̇o2 than those in CBET (2.1 [2.8] mL/kg/min vs 0.8 [2.5] mL/kg/min), with a between-group mean difference of 1.3 mL/kg/min (95% CI, 0.1-2.6 mL/kg/min; P = .03). Compared with the CBET group, the CBCR group also attained a greater mean (SD) reduction in systolic BP (-12.3 [11.8] mm Hg vs -1.9 [12.9] mm Hg; P < .001), diastolic BP (-5.0 [5.7] mm Hg vs -0.5 [7.0] mm Hg; P = .003), and BMI (-1.2 [0.9] vs 0.2 [0.7]; P < .001) and greater mean (SD) improvements in PA levels (1035.2 [735.7] metabolic equivalents [METs]/min/wk vs 34.1 [424.4] METs/min/wk; P < .001), QOL (14.0 [10.0] points vs 0.4 [12.9] points; P < .001), and health literacy scores (2.7 [1.6] points vs 0.1 [1.4] points; P < .001). Exercise adherence was significantly higher in the CBCR group than in the CBET group (mean [SD] sessions completed, 90.3% [11.8%] vs 68.4% [22.1%]; P < .001).The CORE trial showed that a cardio-oncology rehabilitation model among cancer survivors with high cardiovascular risk was associated with greater improvements in peak V̇o2 compared with usual care encompassing an exercise intervention in a community setting. The CBCR also showed superior results in exercise adherence, cardiovascular risk factor control, QOL, and health literacy.ClinicalTrials.gov Identifier: NCT05132998.