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Trial registered on ANZCTR
Registration number
ACTRN12617000587303
Ethics application status
Approved
Date submitted
14/04/2017
Date registered
26/04/2017
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results information initially provided
4/03/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Can High Intensity Interval Training improve fitness before major abdominal surgery?
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Scientific title
High Intensity Interval Training to optimise fitness before major abdominal surgery. Can High Intensity Interval Training improve preoperative fitness and postoperative outcomes?
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Secondary ID [1]
291616
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None
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Universal Trial Number (UTN)
U1111-1195-0805
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prehabilitation
302741
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Abdominal surgery
302742
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Complications after surgery
302914
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Condition category
Condition code
Physical Medicine / Rehabilitation
302256
302256
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0
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Other physical medicine / rehabilitation
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Surgery
302257
302257
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be randomised to 'standard care' or to the intervention. The intervention is a supervised preoperative fitness program. This program will involve 14 sessions of High Intensity Interval Training on a cycle ergometer over 4-6 weeks prior to surgery. The aim is to perform three sessions a week, but depending on the number of available days between enrolment in the study and the date of surgery four sessions a week may be performed.
Exercise will be performed with other patients who are enrolled in the same or similar studies under the supervision of a senior trained exercise physiologist (greater than five years experience) in the School of Physical Education. Exercises will use stationary cycling (Monark cycle ergometers), with monitoring of pulse and blood pressure. For patients on beta blockers the level of perceived exertion, using the 1-20 Borg scale will be monitored as well as the pulse. Each session will begin and end with 5 min of unloaded cycling. Initial sessions will include ten 15-second intervals at a heart rate exceeding 85% of age predicted maximum heart rate, or a rating of perceived exertion (RPE) score of 16, with ‘rest’ intervals of 45 seconds at heart rates of 50% maximum heart rate. All training programs will be individualised to meet the capacity of the participant. The duration of exercise will increase and the duration of rest will decrease as the participant gains fitness. The aim of the 14 session format is for participants to achieve five 2 minute intervals of high intensity work with 2 minute active rest durations. The total interval duration will not exceed 10 minutes throughout the training period. Each session will last approximately 20 to 25 minutes..
For safety reasons, the intensity of exercise and intervals will be adjusted if systolic blood pressure exceeds 180 mm Hg, if the heart rate exceeds 95% of the maximum observed on baseline CPET, or if the perceived exertion on the Borg scale exceeds 18. Pulse (as the indicator of ‘high intensity’) will be monitored and recorded from downloadable Polar Heart Rate monitors to assure exercise adherence. This will be monitored by the exercise physiologist and the duration of the training intervals will be adjusted to reach the required heart rate. Monitoring for adherence will look at the number of sessions attended and the number of sessions where the target heart rate is reached.
Patients who have their surgery delayed will complete one additional HIIT session per week up until surgery to maintain fitness. All adverse events will be recorded.
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Intervention code [1]
297693
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Prevention
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Intervention code [2]
297791
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Treatment: Other
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Comparator / control treatment
The control group will have 'standard care'. They will undergo routine preoperative testing and will be advised to exercise preoperatively, but no supervised exercise program will be provided.
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Control group
Active
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Outcomes
Primary outcome [1]
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The proportion of participants with an increase in peak oxygen consumption (Peak VO2) of >2ml/kg/min as measured by cardiopulmonary exercise testing before and after high intensity interval training.
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Assessment method [1]
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Timepoint [1]
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Testing will be performed prior to randomisation (where those in the intervention group will be randomised to 14 sessions of High intensity interval training) and then before surgery (which will usually be 4 to 5 weeks after randomisation).
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Secondary outcome [1]
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All postoperative complications.
Complications will be assessed in two ways. Inpatient complications will include review of the medical records and discussion with the surgical team managing the patient. Complications after discharge will be assessed by a previously validated telephone questionnaire (. Journal of Surgical Research 206:77-82, 2016)
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Assessment method [1]
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Timepoint [1]
333845
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Inpatient complications will be documented on the day of discharge from hospital. The telephone questionnaire for outpatient complications will be administered six weeks after surgery
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Secondary outcome [2]
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length of Hospital stay after surgery
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Assessment method [2]
333846
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Timepoint [2]
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Documented at the time of discharge from hospital
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Secondary outcome [3]
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Surgical Recovery Score
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Assessment method [3]
333847
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Timepoint [3]
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Documented on postoperative day five and again at six weeks after surgery by administration of the surgical recovery score questionnaire (Journal of Surgical Research 167:e85-e91, 2011)
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Secondary outcome [4]
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Postoperative Morbidity Score
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Assessment method [4]
333848
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Timepoint [4]
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Documented five days after surgery
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Secondary outcome [5]
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Quality of life using SF-36 questionnaire
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Assessment method [5]
333849
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Timepoint [5]
333849
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Documented before randomisation, before surgery and then six weeks and three months after discharge from hospital
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Eligibility
Key inclusion criteria
Patients about to undergo major abdominal surgery. Major abdominal surgery includes any laparotomy. It does not include laparoscopic cholecystectomy or appendicectomy or TURP. It does include abdominal rectal prolapse surgery, nissan fundoplication, and abdominal hysterectomy. It also includes any procedures considered to be more major, in terms of their potential impact on the patient, than the above procedures.
There needs to be sufficient time to perform the preoperative exercise (enrolment needs to be approximately five weeks before surgery) and the participant needs to live close enough to the hospital to be able to attend the exercise sessions.
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Minimum age
45
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Inability to exercise or to perform a CPET
2) Uncontrolled hypertension (BP>180/100)
3) Experiencing clinical angina (Does not include those who are asymptomatic on Rx or those who have had successful revascularization)
4) Myocardial infarction in the past 3/12
5).Uncontrolled cardiac arrhythmias
6) Intracranial aneurysm
7) Aortic aneurysm >6.5cm
8) Severe obstructive pulmonary disease with a FEV1 < 1 litres
9) Inability to provide consent
10) Significant anaemia, Hb <80g/l
11) Short course preoperative radiotherapy
12) Preoperative chemotherapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation using opaque sealed envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
A patient may be randomly assigned to the intervention group (a preoperative exercise program) or to the control group (standard preoperative care).
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Differences in Peak VO2 will be recorded as mean results with standard deviations. Assessing the significant differences before and after HIIT and between the two groups will require mixed effects modelling and an analysis of covariance (ANCOVA) analysis, using baseline fitness as the covariate.
Differences in the SF 36 subscales scores (these give a score between 0 and 100) between the two groups will be assessed using the student t- test or Mann-Whitney U test depending on the distribution of scores. Statistical significance will be set at p<0.05.
The postoperative morbidity survey generates a percentage of patients with or without morbidity. Differences between groups can be compared using the chi-square test. Differences in complication rates between groups will also be compared using the chi-square test or with Fisher’s exact test. The surgical recovery score generates a score between 17 and 100. As the scores are likely to be non-parametric, distribution differences between the groups will be compared using the Mann-Whitney U test. Length of stay data is also likely to be positively skewed and will be compared using the Mann-Whitney U test.
Estimation of the required number of participants is difficult as we need a standard deviation around the change in Peak VO2 to calculate the sample size (So we would want a change in Peak VO2 of 2ml/kg/min with a standard deviation of x ml/kg/min with an estimated 20% drop out rate after randomisation. As it was difficult to get a standard deviation for changes in Peak VO2 with 14 sessions of HIIT it was decided by our statistician to use an 'adaptive design' where we calculate the standard deviation from the first 30 patients (15 patients in each group) and at that stage we will be able to calculate the required number of participants.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
8/09/2015
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Date of last participant enrolment
Anticipated
1/09/2018
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Actual
19/09/2018
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Date of last data collection
Anticipated
1/12/2018
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Actual
3/02/2019
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Sample size
Target
60
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Accrual to date
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Final
63
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Recruitment outside Australia
Country [1]
8799
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New Zealand
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State/province [1]
8799
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Otago
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Funding & Sponsors
Funding source category [1]
296108
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University
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Name [1]
296108
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University of Otago
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Address [1]
296108
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University of Otago
362 Leith Street
North Dunedin
Dunedin 9016
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Country [1]
296108
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New Zealand
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Funding source category [2]
296211
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Charities/Societies/Foundations
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Name [2]
296211
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Health Care Otago Charitable Trust
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Address [2]
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Health Care Otago Charitable Trust
PO Box 1921
Dunedin
New Zealand
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Country [2]
296211
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New Zealand
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Primary sponsor type
Individual
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Name
Dr John Woodfield
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Address
Department of Surgery, Dunedin Public Hospital, Great King Street, Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
295004
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University
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Name [1]
295004
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University of Otago
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Address [1]
295004
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University of Otago
362 Leith Street
North Dunedin
Dunedin 9016
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Country [1]
295004
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New Zealand
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Other collaborator category [1]
279525
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Individual
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Name [1]
279525
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Dr Chris Baldi
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Address [1]
279525
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Department of Medicine
University of Otago
Dunedin Public Hospital
Great King Street
Dunedin 9016
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Country [1]
279525
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New Zealand
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Other collaborator category [2]
279526
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Individual
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Name [2]
279526
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Dr Mathew Zacharias
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Address [2]
279526
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Department of Surgical Sciences
Dunedin Public Hospital
Great King Street
Dunedin 9016
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Country [2]
279526
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297362
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
297362
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Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
297362
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New Zealand
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Date submitted for ethics approval [1]
297362
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30/06/2015
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Approval date [1]
297362
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16/07/2015
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Ethics approval number [1]
297362
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15/STH/116
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Summary
Brief summary
Many of the risk factors associated with developing complications after surgery cannot be changed, such as the extent of the problem requiring surgery, the operation required and the health problems that the patient suffers from. However it may be possible to reduce complications by optimising fitness before surgery. In this study we will examine if fourteen exercise sessions on an exercycle over five weeks can improve overall cardiorespiratory fitness. Fitness will be measured by the peak oxygen consumption, which is measured by cardiopulmonary exercise testing. We will also monitor patients after surgery to check for differences in a range of clinical outcomes including the speed of recovery from surgery, length of hospital stay, complications and quality of life.
Both the individual and the community may benefit from this research. Improving fitness, and potentially improving outcomes will be of benefit to the individual patient. At the community level there is no work being routinely done to improve fitness before surgery. If we demonstrate that improving fitness improves operative outcomes this should lead to the introduction of exercise programs for patients while they are waiting for their surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
1635
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/AnzctrAttachments/372688(v14-04-2017-20-49-53)-Study Protocol for ANZCTR.docx
(Protocol)
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Attachments [2]
1636
1636
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/AnzctrAttachments/372688-HDEC_Letter_-_15STH116_Approved_Application.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
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Dr John Woodfield
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Address
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Department of Surgical Sciences
Dunedin Hospital
Great King Street
Dunedin 9016
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Country
73810
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New Zealand
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Phone
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+64 34740999
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Fax
73810
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Email
73810
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[email protected]
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Contact person for public queries
Name
73811
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Dr John Woodfield
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Address
73811
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Department of Surgical Sciences
Dunedin Hospital
Great King Street
Dunedin 9016
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Country
73811
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New Zealand
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Phone
73811
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+64 34740999
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Fax
73811
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Email
73811
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[email protected]
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Contact person for scientific queries
Name
73812
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Dr John Woodfield
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Address
73812
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Department of Surgical Sciences
Dunedin Hospital
Great King Street
Dunedin 9016
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Country
73812
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New Zealand
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Phone
73812
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+64 34740999
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Fax
73812
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Email
73812
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
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.
2018
https://dx.doi.org/10.1186/s13063-018-2701-9
N.B. These documents automatically identified may not have been verified by the study sponsor.
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