Lavín-Pérez Ana Myriam, Collado-Mateo Daniel, Hinojo González Carmen, de Juan Ferré Ana, Ruisánchez Villar Cristina, Mayo Xián, Jiménez Alfonso
Centre for Sport Studies, Rey Juan Carlos University, Madrid, Spain.
GO fitLAB, Ingesport, Madrid, Spain.
BMC Sports Sci Med Rehabil. 2023 Mar 8;15(1):28. doi: 10.1186/s13102-023-00634-2.
Breast cancer is a chronic disease with a large growth in its treatments, prognosis, improvements, side effects and rehabilitation therapies research. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments, increase patients' strength and quality of life and improve body composition, physical condition and mental health. However, new investigations show the need for a closed exercise individualisation to produce higher physiological, physical and psychological benefits in remote exercise programs. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure for prescribing high-intensity training. Thus, the primary objective of this randomised clinical trial is to analyse the effects of a high-intensity exercise program daily guided by HRV, a preplanned moderate to high-intensity exercise intervention and a usual care group, in breast cancer patients after chemotherapy and radiotherapy treatments.
For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (a control group, a moderate to high-intensity preplanned exercise group and a high-intensity exercise group guided by HRV). Both physical exercise interventions will be developed remotely and supervised including strength and cardiovascular exercises. Physiological variables, such as cardiotoxicity, biomarkers, lipid profile, glucose, heart rate and blood pressure; physical measures like cardiorespiratory capacity, strength, flexibility, agility, balance and body composition; and psychosocial variables, as health-related quality of life, fatigue, functionality, self-esteem, movement fear, physical exercise level, anxiety and depression will be measure before, after the intervention and 3 and 6 months follow up.
Personalized high-intensity exercise could be a promising exercise intervention in contrast to moderate-intensity or usual care in breast cancer patients to reach higher clinical, physical and mental effects. In addition, the novelty of controlling HRV measures daily may reflect exercise effects and patients' adaptation in the preplanned exercise group and a new opportunity to adjust intensity. Moreover, findings may support the effectiveness and security of physical exercise remotely supervised, although with high-intensity exercise, to reach cardiotoxicity improvements and increase physical and psychosocial variables after breast cancer treatments. Trial registration ClinicalTrials.gov nº NCT05040867 ( https://clinicaltrials.gov/ct2/show/record/NCT05040867 ).
乳腺癌是一种慢性病，其治疗、预后、改善、副作用及康复治疗研究都有了大幅进展。这些进展也凸显了将体育锻炼作为一种应对措施的必要性，以降低药物治疗的心脏毒性，增强患者的力量和生活质量，并改善身体成分、身体状况和心理健康。然而，新的研究表明，在远程锻炼计划中，需要进行封闭式的个体化锻炼，以产生更高的生理、身体和心理益处。为此，本研究将以一种新颖的方式，在该人群中使用心率变异性（HRV）作为规定高强度训练的指标。因此，这项随机临床试验的主要目的是分析在化疗和放疗后的乳腺癌患者中，由HRV每日指导的高强度锻炼计划、预先计划的中等至高强度锻炼干预措施以及常规护理组的效果。
为此，将对90名乳腺癌患者进行为期16周的干预，分为3组（对照组、预先计划的中等至高强度锻炼组和由HRV指导的高强度锻炼组）。两种体育锻炼干预措施都将通过远程进行并受到监督，包括力量训练和心血管锻炼。将在干预前、干预后以及随访3个月和6个月时测量生理变量，如心脏毒性、生物标志物、血脂谱、血糖、心率和血压；身体指标，如心肺功能、力量、柔韧性、敏捷性、平衡能力和身体成分；以及社会心理变量，如与健康相关的生活质量、疲劳、功能、自尊、运动恐惧、体育锻炼水平、焦虑和抑郁。
与中等强度或常规护理相比，个性化的高强度锻炼可能是一种有前景的锻炼干预措施，可使乳腺癌患者获得更高的临床、身体和心理效果。此外，每天控制HRV测量值这一新颖做法可能反映出预先计划的锻炼组中的锻炼效果和患者的适应性，以及调整强度的新机会。此外，研究结果可能支持远程监督的体育锻炼（尽管是高强度锻炼）在改善乳腺癌治疗后的心脏毒性以及增加身体和社会心理变量方面的有效性和安全性。试验注册ClinicalTrials.gov编号NCT05040867（https://clinicaltrials.gov/ct2/show/record/NCT05040867）。
