Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000001796
Ethics application status
Approved
Date submitted
19/10/2021
Date registered
10/01/2022
Date last updated
10/01/2022
Date data sharing statement initially provided
10/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised clinical trial comparing preoperative exercise in the home, hospital, and community with standard care in adults awaiting for major abdominal surgery.
Scientific title
A randomised clinical trial comparing preoperative exercise in the home, hospital, and community with standard care in adults awaiting for major abdominal surgery.
Secondary ID [1] 305225 0
21/CEN/139
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a continuation of a pilot study, ACTRN12617000587303

Health condition
Health condition(s) or problem(s) studied:
Prehabilitation 323582 0
Abdominal sugery
 324001 0
Complications after sugery 324002 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321507 321507 0 0
Other physical medicine / rehabilitation
Surgery 321508 321508 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Participants will be randomised to standard care or to 8-14 sessions of high intensity interval training (HIIT) training lasting approximately 30 minutes each (either home-based, in a clinical setting, or at a community gym).
Patients in the HIIT treatment arms will undergo approximately three supervised exercise sessions a week. Each session will begin and end with 5 minutes of cycling against a light load. The high intensity protocol is based around ten one-minute intervals of higher intensity exercise alternating with one-minute periods of lower intensity cycling. The objective is to reach 90% of the maximal heart rate (as identified on CPET) during the periods of intense exercise.
Clinical setting training sessions will be performed at Dunedin Hospital in an approved exercise unit under the supervision of a certified exercise physiologist and another investigator or student involved in this study.
The community setting arm will involve patients exercising individually or in a group co-ordinated by a fitness trainer with some experience in coaching/exercise training (This will be either an employee of a fitness centre who leads training sessions, or an exercise physiologist). This will take place at a local community-focused facility.
The home based training setting will involve Stationary bicycles (Monark Ergomedic 828E) being provided for individual participants in their homes, as in previous studies conducted by one of our team members. Participants will attend a one-hour session with an exercise physiologist who will familiarise them with the training protocol. Use of the heart rate monitor and paired device (watch or phone, provided at the participant’s preference) will be demonstrated during this training session. The participant will train during this session so that they understand what exertion feels like at 90% of their maximum heart rate (or a 15 out of 20 on the BORG17 scale). This is important for participants who are on beta-blockers, and also if the heart rate monitor or paired device fails during a session.

Participants will be encouraged to train three times a week, with the objective of achieving 10 minutes of intense exercise aiming to reach 90% of their maximum heart rate as identified with CPET, as per our previously outlined protocol. The participant will upload heart rate data to the Polar Flow website, which will be accessible to study investigators. Heart rate and interval duration are recorded and displayed so that each session can be remotely monitored. The research assistant or physiologist will contact the participant twice a week to check on heart rate targets, to advise on adjustments of exercise intensity and duration of intense intervals.
The duration of the exercise period is for 14 sessions, with the aim of this being achieved in four weeks, but may extend to six weeks if the patient misses a session.
Intervention code [1] 321623 0
Prevention
Intervention code [2] 322252 0
Treatment: Other
Comparator / control treatment
Patients randomised to standard care will be given instructions for improving their fitness and referred to the Green Prescription programme that is currently available in the SDHB ((https://www.health.govt.nz/your-health/healthy-living/food-activity-and-sleep/green-prescriptions). The programme coordinators work with local gyms offering discounted exercise sessions, and tailor advice to individuals. The activity they provide is lower intensity and less structured than our proposed study interventions. This allows participants to make some gains in overall fitness, but still act as a control as this is not focused on aerobic exercise.
Sessions will be approximately 30 minutes, three times a week. The duration of the exercise period is for 14 sessions, with the aim of this being achieved in four weeks, but may extend to six weeks if the patient misses a session.
Control group
Active

Outcomes
Primary outcome [1] 329277 0
The primary outcome of the study is the change in VO2peak from baseline to post intervention as measured with CPET. This will be measured with a cardiopulmonary test on a stationary cycle ergometer. During this test, we will use spirometry to measure the exchange of respiratory gasses to determine the patient's oxygen consumption during cycling on a stationary cycle ergometer. After 3 minutes of resting (for resting spirometry and to let gas exchange variables stabilise), the test will proceed with a ramp protocol of incremental resistance on the stationary cycle ergometer until termination, followed by 5 minutes of active recovery against no resistance. Heart rate, 12-lead electrocardiogram, blood pressure and pulse oximetry are assessed throughout the procedure in order to provide safety monitoring and will not be considered outcomes. An automated external defibrillator is present on site and there is a phone line to a designated arrest team in case of any cardiac event. The peak oxygen consumption (peak VO2) will be measured using online gas analysis (Quark B2), part of the Cosmed Cardio-Pulmonary Exercise Testing system (Cosmed, Rome, Italy).
Timepoint [1] 329277 0
The peak oxygen consumption will be measured twice for participants who complete the exercise program, at baseline and after 14 exercise sessions.
Secondary outcome [1] 401988 0
Quality of Life- measured via the short form health questionnaire (SF-36). This validated questionnaire has been used by our research group previously and gives an indication of the patient's perceived quality of life.
Timepoint [1] 401988 0
The first SF-36 questionnaires will be administered at the time of the HIIT sessions, subsequent questionnaires will be mailed out to the participants. Quality of life will be recorded at baseline, after HIIT/before surgery, six weeks after surgery, and twelve weeks after surgery.
Secondary outcome [2] 401989 0
Exercise: All participants will keep an exercise diary and will be provided with a pedometer. These will be used to capture their overall level of exercise over the time period they are included in the study and up to the time of surgery. The exercise will be both that of the study and the participant's own, individual activity level.
Timepoint [2] 401989 0
Exercise will be recorded from the time of the first CPET and for the following eight weeks up to the time of their final CPET.
Secondary outcome [3] 401990 0
Clinical Outcomes: length of hospital stay. This will be determined from a review of the medical records and discussion with the surgical team managing the patient.
Timepoint [3] 401990 0
Length of stay is defined as the number of postoperative days stayed in hospital, with day one being the day of surgery.
Secondary outcome [4] 401992 0
Clinical outcomes: Post Operative Morbidity Survey. This is a validated questionnaire used to assess postoperative adverse events in 9 different categories.
Timepoint [4] 401992 0
For patients undergoing surgery, this will be recorded at the hospital 5 days after the operation.
Secondary outcome [5] 401993 0
Clinical outcomes: complications. Complications will be assessed in two ways. Inpatient complications will include a 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 [5] 401993 0
Five days after surgery and 6 weeks after surgery.
Secondary outcome [6] 401994 0
Differences in cost between hospital based, home based and gym based groups. The cost of exercise will include the cost of provision of the cycle ergometer, supervision of exercise and use of exercise facilities. The estimated costs of outcomes after surgery will be a summation of the costs of length of stay, duration of surgery, return to theatre costs, major radiological procedure costs, courses of antibiotics, readmission to hospital (incorporating the above costs) and assessments made by a health professional after discharge (looking at number of GP, GP nurse, district nurse, ED and outpatient visits). Assessment of costs will be undertaken by a blinded investigator, and continued until six weeks after discharge.
Timepoint [6] 401994 0
The cost of exercise will be assessed at six weeks post-discharge.
Secondary outcome [7] 401995 0
Adverse events. An adverse event (AE) is any untoward medical event affecting a clinical trial participant including where the occurrence does not necessarily have a causal relationship with the intervention. This may include symptoms associated with the disease or disorder under study, which are more severe than expected. AE will be assessed throughout the trial by the research assistant at Dunedin Hospital and at the patient's home.
Timepoint [7] 401995 0
Adverse events (AE) will be monitored throughout the trial. Patients will be encouraged to contact the investigators if they experience any discomfort or pain. Research staff will also contact the participants exercising at home and in the community once every week, during which time the patients will be queried for any AE.
Secondary outcome [8] 401996 0
Qualitative data regarding barriers and facilitators to exercise. A research assistant will collect survey data on the barriers and facilitators to exercise after the second CPET and prior to surgery. This survey will have the following questions: 1. Size of house, 2. Description of space for exercise, 3. Number of household members, 4. Description of available internet-capable devices, 5. Description of internet access.
Timepoint [8] 401996 0
Participants will be asked the qualitative survey questions twice, once after the first CPET, and second after the intervention and prior to surgery.

Eligibility
Key inclusion criteria
One of the following: 1.) Patients on the surgical waiting list for the following elective operative procedures: major bowel surgery, incisional hernia repair, cholecystectomy, hysterectomy and prostate surgery. 2.) Patients referred by a cardiologist, respiratory physician or geriatrician. Participants must be able to attend multiple supervised exercise sessions at the hospital and be identifiable from surgery waiting lists approximately two months before the estimated time of surgery.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to perform CPET,

2) Contraindication to exercise diagnosed on CPET,

3) Uncontrolled hypertension (Blood Pressure >180/100),

4) Active clinical angina (This does not include patients with a history of ischaemic heart disease who have no symptomatic angina on appropriate medical treatment or no angina following a successful revascularization procedure),

5) myocardial infarction in the past three months,

6) uncontrolled cardiac arrhythmias,

7) aortic aneurysm >6.5cm,

8) severe obstructive pulmonary disease with a FEV1 < 1.0 litres,

9) inability to provide consent,

10) Preoperative chemotherapy or radiotherapy which overlaps with the period of preoperative exercise.

11) Anaemia, with an Iron infusion planned to be given during the period of preoperative exercise

12) Participants already participating in an aerobic exercise training programme similar to HIIT training (high intensity for more than ten minutes, more than three times per week)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sealed, opaque envelopes. However, as patients out of the Hospital Catchment (more than one hour's drive away) will not be randomised to the Hospital-based arm, we will know that the arms that are possible to be allocated to for the "out of hospital catchment" group will be fewer. We will still maintain allocation concealment for patients near the hospital and away from the hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to generate the randomisation sequence. Separate sequences will be used for patients living more than an hour away from a hospital. This will be quasi-randomised because patients that are not in the Hospital Catchment will be randomised separately, as we will not be able to provide hospital based training to these patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
See above: This will be quasi-randomised because patients that are not in the Hospital Catchment will be randomised separately, as we will not be able to provide hospital based training to these patients.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Patient baseline characteristics will be described using appropriate descriptive statistics (mean and standard deviation or median and interquartile range appropriate for continuous variables; count and percentage for categorical and grouped variables). Change in VO2peak will be assessed in each treatment arm and will be compared between arms using a paired t-test and an appropriate version of OLS regression adjusting for confounding variables (such as differences in age, ASA, magnitude of surgery between the groups) identified in preliminary descriptive analyses. Comparison of specific aspects of the exercise program, such as duration of intense exercise, progression of exercise intensity over time and adherence will be summarised and directly compared. Differences in complications and adverse events between treatment groups will be compared using the chi-square test or Fisher’s exact test, and multivariable logistic regression models. Length of hospital stay, POMS, SF-36 scores, and costs will be compared using a version of OLS regression suitable for each outcome. The duration from HIIT to surgery will also be treated as an adjusting variable for all post-surgery outcome comparisons. A sub analysis comparing results for VO2peak from patients recruited in Dunedin with those outside of Dunedin will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment outside Australia
Country [1] 24096 0
New Zealand
State/province [1] 24096 0
Otago

Funding & Sponsors
Funding source category [1] 309601 0
University
Name [1] 309601 0
University of Otago
Country [1] 309601 0
New Zealand
Funding source category [2] 309944 0
Charities/Societies/Foundations
Name [2] 309944 0
Maurice and Phillis Paykel trust
Country [2] 309944 0
New Zealand
Primary sponsor type
Hospital
Name
Dunedin Hospital
Address
201 Great King Street, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 310614 0
None
Name [1] 310614 0
Address [1] 310614 0
Country [1] 310614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309376 0
Health and Disability Ethics Committee
Ethics committee address [1] 309376 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 309376 0
New Zealand
Date submitted for ethics approval [1] 309376 0
Approval date [1] 309376 0
19/07/2021
Ethics approval number [1] 309376 0
24/05/2021

Summary
Brief 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 14 sessions over four weeks (12 sessions and two 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113938 0
Dr John Woodfield
Address 113938 0
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9016
Country 113938 0
New Zealand
Phone 113938 0
+6434740999
Fax 113938 0
Email 113938 0
john.woodfield@otago.ac.nz
Contact person for public queries
Name 113939 0
Dr Kari Clifford
Address 113939 0
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9016
Country 113939 0
New Zealand
Phone 113939 0
+64210668369
Fax 113939 0
Email 113939 0
kari.clifford@otago.ac.nz
Contact person for scientific queries
Name 113940 0
Dr Kari Clifford
Address 113940 0
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9016
Country 113940 0
New Zealand
Phone 113940 0
+64210668369
Fax 113940 0
Email 113940 0
kari.clifford@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Study results for primary outcomes will be available.
When will data be available (start and end dates)?
Data will be available following publication of results and for ten years afterwards
Available to whom?
Data will be available to any researcher
Available for what types of analyses?
Data will be available for any purpose
How or where can data be obtained?
Data will be available to researchers upon reasonable request to the study coordinating investigator

email: kari.clifford@otago.ac.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13629Study protocol  kari.clifford@otago.ac.nz
13630Statistical analysis plan  kari.clifford@otago.ac.nz
13631Informed consent form  kari.clifford@otago.ac.nz
13632Analytic code  kari.clifford@otago.ac.nz



Results publications and other study-related documents

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