RecruitingACTRN12618001643268

“HIITing” the Mark: The developing an optimal high-intensity interval training (HIIT) protocol for improving fitness before abdominal surgery


Sponsor

Dunedin Hospital

Enrollment

50 participants

Start Date

Apr 10, 2019

Study Type

Interventional

Conditions

Summary

Many of us will require a major operation during our lifetime. Complications after surgery are common, and medical staff continue to explore ways to reduce this. Although many risk factors, such as our health problems and the operation required cannot be changed, it has been demonstrated that we can improve fitness over 4-6 weeks before surgery. In our first study, we have achieved a greater than 10% improvement in fitness before surgery. In this study, we will examine what an ideal aerobic preoperative exercise program, including for patients with different levels of fitness, should look like. This study will compare two groups of participants, a high risk and an average risk group, who are scheduled for abdominal surgery. Fitness, defined as peak oxygen consumption (peak VO2), will be measured by cardiopulmonary exercise testing (CPET). The exercise program will include 24 sessions over eight weeks (19 exercise sessions and 5 CPET). The changes in peak VO2 will be compared against the number of exercise sessions to construct ‘dose-response’ curves, which will be used to recommend evidence-based preoperative exercise programs for both average and high-risk patients. Postoperative outcomes including complications, recovery from surgery, and quality of life will also be compared.


Eligibility

Sex: Both males and femalesMin Age: 55 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

Major abdominal surgery carries significant risks of complications, and one of the strongest predictors of how well someone will recover is their pre-operative fitness level. Research has shown that people can meaningfully improve their aerobic fitness in just four to eight weeks with targeted exercise training before surgery — a concept called 'prehabilitation.' But we do not yet know the ideal exercise prescription: how many sessions, at what intensity, for which patients? This study works with people aged 55 to 85 who are scheduled for major abdominal surgery. Participants undergo 24 sessions over eight weeks including fitness testing and supervised exercise. By measuring fitness improvements session by session, researchers can build 'dose-response' curves — essentially a graph showing how much fitness gain each additional exercise session produces — for both average-risk and high-risk patients. Post-operative outcomes including complications and recovery are also tracked. To be eligible you need to be aged 55 to 85 and be scheduled for major bowel surgery, hernia repair, cholecystectomy, hysterectomy, or prostate surgery, or have been referred by a specialist for pre-surgical conditioning. You must be able to attend multiple supervised exercise sessions at the hospital. People who cannot exercise safely, have uncontrolled heart conditions or very severe lung disease, or who are receiving chemotherapy or radiotherapy during the exercise period are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A full pre-operative anaesthetic assessment will be performed for each participant, and this is part of the standard treatment that they receive if they are patients scheduled for abdominal surgery. P

A full pre-operative anaesthetic assessment will be performed for each participant, and this is part of the standard treatment that they receive if they are patients scheduled for abdominal surgery. Participants will be categorised as either fit or unfit, by means of the Duke Activity Survey, initial cardiopulmonary exercise testing (CPET), and a modified frailty index. CPET will be performed on an electromagnetically braked ergometer using individualised stepped protocols based on the individual’s fitness levels. This will be supervised by a senior researcher with medical staff also on site. Peak VO2, anaerobic threshold, respiratory exchange ratio and the workloads required to elicit 60% and 90% maximal heart rate will be documented. CPET will be repeated throughout the exercise program to test for changes in Peak VO2. The exercise program will include 24 sessions, 3-4 times a week, over approximately eight weeks. This will include five sessions of CPET (sessions 1,6,10,14 and 24) and 19 of HIIT. The HIIT sessions, which will be supervised by a trained exercise physiologist, will be performed on Monarch cycle ergometers, with monitoring of pulse and blood pressure. The HIIT sessions will aim to achieve ten 1-minute intervals of high-intensity cycling (against resistance) followed by ten 1-minute intervals of active rest (gentle cycling against no resistance) and will then progress to five 2-minute intervals of high-intensity work followed by 2-minutes of active rest. Intense exercise may be for shorter periods of time in unfit participants. The sessions will be individualized, with differences in the duration of intense exercise on starting HIIT, progression of exercise intensity over time, and adherence to exercise targets (such as reaching a heart rate of 90% of an age defined maximal heart rate) being noted. Whilst the session is individualised, we may have groups of up to 4 patients undertaking a HIIT session at a time, and this will take place at Dunedin Hospital in an exercise room. If the participant’s surgery is delayed, he or she will be invited to complete one additional HIIT session per week up until surgery. Each session will last approximately 30 minutes. After surgery, patients will complete a postoperative morbidity survey and quality of life questionnaire.


Locations(1)

Otago, New Zealand

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ACTRN12618001643268


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