Discipline of Physiotherapy, School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
BMC Cancer. 2020 Apr 15;20(1):321. doi: 10.1186/s12885-020-06795-4.
Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly, targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery and, through evaluation of health economics, the impact of the programme on hospital costs.
The PRE-HIIT Randomised Controlled Trial (RCT) will compare a 2-week high intensity interval training (HIIT) programme to standard preoperative care in a cohort of thoracic and oesophageal patients who are > 2-weeks pre-surgery. A total of 78 participants will be recruited (39 per study arm). The primary outcome is cardiorespiratory fitness. Secondary outcomes include, measures of pulmonary and physical and quality of life. Outcomes will be measured at baseline (T0), and post-intervention (T1). Post-operative morbidity will also be captured. The impact of PRE-HIIT on well-being will be examined qualitatively with focus groups/interviews post-intervention (T1). Participant's experience of preparation for surgery on the PRE-HIIT trial will also be explored. The healthcare costs associated with the PRE-HITT programme, in particular acute hospital costs, will also be examined.
The overall aim of this RCT is to examine the effect of tailored, individually prescribed high intensity interval training aerobic exercise on pre-operative fitness and postoperative recovery for patients undergoing complex surgical resections, and the impact on use of health services.
The study is registered with Clinical Trials.Gov (NCT03978325). Registered on 7th June 2019.
接受根治性治疗的肺癌或食道癌患者通常需要进行开胸手术和复杂的肿瘤切除术。这些手术有发生重大发病率和死亡率的风险，风险评估、术前优化和术后加速康复（ERAS）途径是优化结果的现代方法。术前体能是术后结果的既定预测指标，因此，通过运动预康复来针对术前体能进行靶向治疗具有合理的吸引力。然而，由于在诊断和手术之间干预的机会很短，因此，运动预康复的实施具有挑战性。因此，需要研究能够在短时间内使心肺功能得到临床有意义改善的个体化、强化运动训练方案。本项目将研究运动预康复对生理结果和术后恢复的影响，并通过评估健康经济学，研究该方案对医院成本的影响。
PRE-HIIT 随机对照试验（RCT）将比较高强度间歇训练（HIIT）方案与胸部和食管患者的标准术前护理，这些患者在手术前 >2 周。将招募 78 名参与者（每组 39 名）。主要结果是心肺功能。次要结果包括肺功能和物理及生活质量测量。结果将在基线（T0）和干预后（T1）进行测量。术后发病率也将被捕获。PRE-HIIT 对幸福感的影响将通过干预后（T1）的焦点小组/访谈进行定性评估。还将探讨 PRE-HIIT 试验中患者对手术准备的体验。还将研究与 PRE-HIITT 方案相关的医疗保健成本，特别是急性医院成本。
该 RCT 的总体目标是研究量身定制的个体化高强度间歇训练有氧运动对接受复杂手术切除的患者术前体能和术后恢复的影响，以及对卫生服务使用的影响。
该研究在 ClinicalTrials.gov 上注册（NCT03978325）。于 2019 年 6 月 7 日注册。
