Viamonte Sofia Gonçalves, Joaquim Ana Vieira, Alves Alberto, Vilela Eduardo, Capela Andreia, Ferreira Cristina, Duarte Barbara, Rato Nuno Dias, Tavares Aida Isabel, Santos Mário, Ribeiro Fernando
North Rehabilitation Center, Centro Hospitalar Vila Nova de Gaia, Espinho, Portugal; ONCOMOVE® - Associação de Investigação de Cuidados de Suporte em Oncologia (AICSO), Portugal.
ONCOMOVE® - Associação de Investigação de Cuidados de Suporte em Oncologia (AICSO), Portugal; Oncology Department, Centro Hospitalar Vila Nova de Gaia, Espinho, Portugal.
Int J Cardiol. 2023 Jan 15;371:384-390. doi: 10.1016/j.ijcard.2022.09.075. Epub 2022 Oct 8.
Cancer survivors are challenging patients, as they often present increased cardiovascular risk. In this background, cardio-oncology rehabilitation frameworks for specific cancer patients have been proposed. However, optimal program designs, as well as their overall safety and efficacy in different subsets of patients, are not fully ascertained.
Single-center, pragmatic, prospective, randomized controlled trial performed in Portugal aiming to evaluate the impact of a center-based cardiac rehabilitation program, consisting of exercise training, nutritional counselling, psychosocial management and lifestyle behavior change, compared to community-based exercise training, in cancer survivors.
Adult cancer survivors (N = 80) exposed to cardiotoxic cancer treatment and/or with previous cardiovascular disease will be randomized (1:1) to receive either an eight-week cardiac rehabilitation program or community-based exercise training. Primary endpoint is cardiorespiratory fitness; secondary endpoints are physical activity, psychosocial parameters, blood pressure, body composition, lipids and inflammatory parameters. Physical function, quality of life, fatigue, health literacy, and feasibility will be assessed; a cost-effectiveness evaluation will also be performed. Between-group differences at baseline and in the change from baseline to the end of the study will be tested with unpaired t-tests or Mann-Whitney U test. Paired t-tests or Wilcoxon signed-rank test will be performed for within-group comparisons.
This trial will address the overall impact of a contemporary cardiac rehabilitation program framework in cancer survivors, as compared to a community-based exercise training. Given the higher cardiovascular risk in several groups of cancer patients, our results could provide novel insights into optimized preventive strategies in this complex patient population.
癌症幸存者是具有挑战性的患者，因为他们往往存在心血管风险增加的情况。在此背景下，已针对特定癌症患者提出了心脏肿瘤康复框架。然而，最佳方案设计及其在不同患者亚组中的整体安全性和有效性尚未完全确定。
在葡萄牙进行的单中心、务实、前瞻性、随机对照试验，旨在评估与基于社区的运动训练相比，由运动训练、营养咨询、心理社会管理和生活方式行为改变组成的基于中心的心脏康复计划对癌症幸存者的影响。
成年癌症幸存者（N = 80），曾接受过心脏毒性癌症治疗和/或患有既往心血管疾病，将被随机分组（1:1），接受为期八周的心脏康复计划或基于社区的运动训练。主要终点是心肺适能；次要终点是身体活动、心理社会参数、血压、身体成分、血脂和炎症参数。将评估身体功能、生活质量、疲劳、健康素养和可行性；还将进行成本效益评估。组间基线差异以及从基线到研究结束时的变化差异将使用不成对t检验或曼-惠特尼U检验进行测试。组内比较将进行配对t检验或威尔科克森符号秩检验。
与基于社区的运动训练相比，本试验将探讨当代心脏康复计划框架对癌症幸存者的整体影响。鉴于几组癌症患者的心血管风险较高，我们的结果可为优化这一复杂患者群体的预防策略提供新的见解。
