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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can High Intensity Interval Training improve fitness before major abdominal surgery?
Scientific title
High Intensity Interval Training to optimise fitness before major abdominal surgery. Can High Intensity Interval Training improve preoperative fitness and postoperative outcomes?
Secondary ID [1] 291616 0
None
Universal Trial Number (UTN)
U1111-1195-0805
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prehabilitation 302741 0
Abdominal surgery 302742 0
Complications after surgery 302914 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302256 302256 0 0
Other physical medicine / rehabilitation
Surgery 302257 302257 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 297693 0
Prevention
Intervention code [2] 297791 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 301778 0
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.
Timepoint [1] 301778 0
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).
Secondary outcome [1] 333845 0
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)
Timepoint [1] 333845 0
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
Secondary outcome [2] 333846 0
length of Hospital stay after surgery
Timepoint [2] 333846 0
Documented at the time of discharge from hospital
Secondary outcome [3] 333847 0
Surgical Recovery Score
Timepoint [3] 333847 0
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)
Secondary outcome [4] 333848 0
Postoperative Morbidity Score
Timepoint [4] 333848 0
Documented five days after surgery
Secondary outcome [5] 333849 0
Quality of life using SF-36 questionnaire
Timepoint [5] 333849 0
Documented before randomisation, before surgery and then six weeks and three months after discharge from hospital

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.
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation using opaque sealed envelopes
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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).
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/09/2015
Date of last participant enrolment
Anticipated
1/09/2018
Actual
19/09/2018
Date of last data collection
Anticipated
1/12/2018
Actual
3/02/2019
Sample size
Target
60
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 8799 0
New Zealand
State/province [1] 8799 0
Otago

Funding & Sponsors
Funding source category [1] 296108 0
University
Name [1] 296108 0
University of Otago
Country [1] 296108 0
New Zealand
Funding source category [2] 296211 0
Charities/Societies/Foundations
Name [2] 296211 0
Health Care Otago Charitable Trust
Country [2] 296211 0
New Zealand
Primary sponsor type
Individual
Name
Dr John Woodfield
Address
Department of Surgery, Dunedin Public Hospital, Great King Street, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 295004 0
University
Name [1] 295004 0
University of Otago
Address [1] 295004 0
University of Otago
362 Leith Street
North Dunedin
Dunedin 9016
Country [1] 295004 0
New Zealand
Other collaborator category [1] 279525 0
Individual
Name [1] 279525 0
Dr Chris Baldi
Address [1] 279525 0
Department of Medicine
University of Otago
Dunedin Public Hospital
Great King Street
Dunedin 9016
Country [1] 279525 0
New Zealand
Other collaborator category [2] 279526 0
Individual
Name [2] 279526 0
Dr Mathew Zacharias
Address [2] 279526 0
Department of Surgical Sciences
Dunedin Public Hospital
Great King Street
Dunedin 9016
Country [2] 279526 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297362 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 297362 0
Ethics committee country [1] 297362 0
New Zealand
Date submitted for ethics approval [1] 297362 0
30/06/2015
Approval date [1] 297362 0
16/07/2015
Ethics approval number [1] 297362 0
15/STH/116

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1635 1635 0 0
/AnzctrAttachments/372688(v14-04-2017-20-49-53)-Study Protocol for ANZCTR.docx (Protocol)
Attachments [2] 1636 1636 0 0
/AnzctrAttachments/372688-HDEC_Letter_-_15STH116_Approved_Application.pdf (Ethics approval)

Contacts
Principal investigator
Name 73810 0
Dr John Woodfield
Address 73810 0
Department of Surgical Sciences
Dunedin Hospital
Great King Street
Dunedin 9016
Country 73810 0
New Zealand
Phone 73810 0
+64 34740999
Fax 73810 0
Email 73810 0
john.woodfield@otago.ac.nz
Contact person for public queries
Name 73811 0
John Woodfield
Address 73811 0
Department of Surgical Sciences
Dunedin Hospital
Great King Street
Dunedin 9016
Country 73811 0
New Zealand
Phone 73811 0
+64 34740999
Fax 73811 0
Email 73811 0
john.woodfield@otago.ac.nz
Contact person for scientific queries
Name 73812 0
John Woodfield
Address 73812 0
Department of Surgical Sciences
Dunedin Hospital
Great King Street
Dunedin 9016
Country 73812 0
New Zealand
Phone 73812 0
+64 34740999
Fax 73812 0
Email 73812 0
john.woodfield@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseProtocol, 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.2018https://dx.doi.org/10.1186/s13063-018-2701-9
N.B. These documents automatically identified may not have been verified by the study sponsor.