Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial

Gráinne Sheill, Emer Guinan, Linda O'Neill, Charles Normand, Suzanne L Doyle, Sarah Moore, John Newell, Grainne McDermott, Ronan Ryan, John V Reynolds, Juliette Hussey, Gráinne Sheill, Emer Guinan, Linda O'Neill, Charles Normand, Suzanne L Doyle, Sarah Moore, John Newell, Grainne McDermott, Ronan Ryan, John V Reynolds, Juliette Hussey

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: The study is registered with Clinical Trials.Gov (NCT03978325). Registered on 7th June 2019.

Keywords: Exercise; Fitness; Prehabilitation; Preoperative care.

Conflict of interest statement

Dr. Emer Guinan is a member of the editorial board (Associate Editor) of this journal. Other authors have no competing interests to disclose.

Figures

Fig. 1
Fig. 1
The Pre-HIIT Trial
Fig. 2
Fig. 2
Key timepoints for assessing outcomes of exercise prehabilitation intervention

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