Protocol, and practical challenges, for a randomised controlled trial comparing the impact of high intensity interval training against standard care before major abdominal surgery: study protocol for a randomised controlled trial

Abstract

BackgroundRisk factors, such as the number of pre-existing co-morbidities, the extent of the underlying pathology and the magnitude of the required operation, cannot be changed before surgery. It may, however, be possible to improve the cardiopulmonary fitness of the patient with an individualised exercise program. We are performing a randomised controlled trial (RCT) assessing the impact of High Intensity Interval Training (HIIT) on preoperative cardiopulmonary fitness and postoperative outcomes in patients undergoing major abdominal surgery.MethodsConsecutive eligible patients undergoing elective abdominal surgery are being randomised to HIIT or standard care in a 1:1 ratio. Participants allocated to HIIT will perform 14 exercise sessions on a stationary cycle ergometer, over a period of 4–6 weeks before surgery. The sessions, which are individualised, aim to start with ten repeated 1-min blocks of intense exercise with a target of reaching a heart rate exceeding 90% of the age predicted maximum, followed by 1 min of lower intensity cycling. As endurance improves, the duration of exercise is increased to achieve five 2-min intervals of high intensity exercise followed by 2 min of lower intensity cycling. Each training session lasts approximately 30 min. The primary endpoint, change in peak oxygen consumption (Peak VO2) measured during cardiopulmonary exercise testing, is assessed at baseline and before surgery. Secondary endpoints include postoperative complications, length of hospital stay and three clinically validated scores: the surgical recovery scale; the postoperative morbidity survey; and the SF-36 quality of life score. The standard deviation for changes in Peak VO2 will be assessed after the first 30 patients and will be used to calculate the required sample size.DiscussionWe want to assess if 14 sessions of HIIT is sufficient to improve Peak VO2 by 2 mL/kg/min in patients undergoing major abdominal surgery and to explore the best clinical endpoint for a subsequent RCT designed to assess if improving Peak VO2 will translate into improving clinical outcomes after surgery.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617000587303. Registered on 26 April 2017.

Prehabilitation before major intra-abdominal cancer surgery

“…Patients who do not live near a hospital are also often unable and/or unwilling to participate in a hospital-based programme. 39,40 In addition to improving pre-operative physical fitness, prehabilitation may provide patients with the skills and awareness needed to start mobilising, practise transfers and to be physically active quickly after surgery, enhancing and accelerating the recovery of physical functioning as a result. Prehabilitation at home or in a community-based setting with adequate supervision allows patients to acquire these skills in their own environment, a setting to which they return after hospital discharge, and this makes it more likely that patients will start exercising again soon after surgery.…”

Short‐term high‐intensity interval training improves fitness before surgery: A randomized clinical trial

“…The study was approved by the Southern Health and Disability Ethics Committee (reference number 15/STH/116) and was registered with the Australasian Clinical Trials Registry (ACTRN12617000587303). An overview of the study design is presented in Figure 1 and in our protocol paper 26 . The inclusion criteria were patients aged 45–85 undergoing major abdominal surgery, who lived close enough to the hospital to attend multiple exercise sessions.…”

“…After consent, CPET was performed on a stationary cycle ergometer (Quark Ergoline). The CPET protocol has been previously published 26 . Tests were terminated when the participant achieved a maximal effort or for medical reasons 28 .…”

High‐intensity exercise training improves perioperative risk stratification in the high‐risk patient

“…The optimum components of an exercise program have yet to be elucidated as much of the evidence is relatively recent (Minnella & Carli, 2018). Given the short time period that cancer patients have between diagnosis and surgery, HIIT training seems to confer the greatest advantages and current trials are ongoing to determine this (Woodfield et al, 2018).…”