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Trial registered on ANZCTR


Registration number
ACTRN12620000073909
Ethics application status
Approved
Date submitted
11/10/2019
Date registered
30/01/2020
Date last updated
30/01/2020
Date data sharing statement initially provided
30/01/2020
Date results information initially provided
30/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise Prehabilitation in High Risk Cancer Surgery: A Feasibility Study
Scientific title
Exercise Prehabilitation and Pulmonary Bundle in High Risk Cancer Surgery (ExPREHAB Plus): A Feasibility Study
Secondary ID [1] 299337 0
Nil
Universal Trial Number (UTN)
Trial acronym
ExPREHAB Plus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Abdominal Cancer Surgery 314488 0
Condition category
Condition code
Cancer 312826 312826 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 312827 312827 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 312828 312828 0 0
Oesophageal (gullet)
Cancer 312829 312829 0 0
Stomach
Physical Medicine / Rehabilitation 313191 313191 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be prescribed an exercise program for a period of six weeks or up until surgery (whichever is earlier). Exercise prescriptions will be individualized to a participant’s prior aerobic fitness, medical comorbidities, response to any prior treatment and any immediate negative treatment effects of prior treatment (such as ongoing neuropathy and/or cancer cachexia) as per the ACSM Guidelines for exercise prescription.

Exercise programs will be conducted one-on-one either in person in a hospital-based gym or unsupervised within the home environment based on the patient's preference and ability to travel to the hospital.
Exercise programs will be moderate to vigorous intensity as rated by the Borg RPE rating scale and prescribed in conjunction with cardiopulmonary exercise testing results.
Exercise programs will include at least 3x30min aerobic exercise (walking/cycling/swimming) and 2x30min resistance sessions (upper and lower body strengthening exercises e.g. sit to stand, step ups, shoulder press) per week based on whether participants are meeting the ACSM exercise prescription guidelines at baseline. Participants will also be provided with a respiratory education session including information regarding breathing exercises to complete in the lead up to surgery.

Given the complexity of this patient sample exercise prescription will also be adapted upon previous musculoskeletal injuries/issues (e.g. previous total joint replacements) and patients exercise preferences, to increase adherence with six-week program. Exercise programs will be progressed by a qualified physiotherapist and/or exercise physiologist based on participant’s response to exercise and compliance with the exercise program.

The 30 min respiratory education session, delivered by a Physiotherapist, will include education, instruction and practice of Active Cycle of Breathing Exercises as well as education on preventing post-operative pulmonary complications by utilising breathing exercises as well as early mobilisation. Participants are encouraged to practice their breathing exercises 2x per day for 10 min. Education will delivered at any point during the six week intervention. No specific strategies will be used to monitor adherence to the breathing exercises.
Intervention code [1] 315609 0
Rehabilitation
Intervention code [2] 315831 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321442 0
Feasibility of delivering a six week individualized Exercise Prehabilitation Program amongst high risk surgical patients presenting for major cancer surgery.
Feasibility of the program will be defined as:
• Percentage of patients consenting to the exercise program = >70% consent rate
• >70% adherence to exercise prescribed, as determined by participant exercise diaries
• >85% retention in the study (Measures of non-compliance including dropout rates and reasons for drop out)
• Intervention acceptability to patients
• Cost of resources to run the study
Timepoint [1] 321442 0
Prior to surgery
Secondary outcome [1] 374963 0
Explore the effects of preoperative exercise training in high risk patients on Cardiorespiratory Function using the Anaerobic Threshold and VO2 peak on Cardiopulmonary Exercise testing.
Timepoint [1] 374963 0
Assessment conducted at baseline and after completion of the six week exercise program or before surgery (whichever comes first).
Secondary outcome [2] 374964 0
Explore the effects of preoperative exercise training in high risk patients on health related quality of life questionnaire, Functional Assessment of Cancer Therapy: General (FACT-G).
Timepoint [2] 374964 0
Assessment conducted at baseline and after completion of the six week exercise program or before surgery (whichever comes first).
Secondary outcome [3] 374965 0
Explore the effects of preoperative exercising training in high risk patents on post-operative complications using the Clavien-Dindo Classification (from any deviation from normal postoperative course without need for pharmacological treatment up until life threatening complications requiring ICU management or death of a patient) and Postoperative Morbidity Survey (pulmonary, infectious, renal, gasto-intestinal, cardio-vascular neurological, hemato-logical, wound, or pain) using medical chart review.
Timepoint [3] 374965 0
Up to day 5 post-operatively.
Secondary outcome [4] 375958 0
Length of hospital stay
Timepoint [4] 375958 0
30 days postoperatively
Secondary outcome [5] 375965 0
Post operative pulmonary complications (PPC) (e.g. pneumonia, respiratory failure, atelectasis, sputum retention, pneumothorax, pleural effusion and pleural oedema) using the Melbourne Group Score PPC diagnostic criteria for the first 3 days post-operatively by medical chart review.
Timepoint [5] 375965 0
First three days post-operatively.

Eligibility
Key inclusion criteria
Eligibility criteria:
• Planned to have major abdominal cancer surgery*
• Adults greater than or equal to 18 years of age
• English speaking
• >2 weeks prior to surgery
• Outpatients or in-patients with planned discharge from hospital in less than 1 week
• Poor cardiorespiratory fitness determined by any one of the following: AT less than or equal to 11ml/kg/min, VO2 Peak less than or equal to 15ml/kg/min or VO2 Peak less than or equal to 710ml/min/m2
• For those unable to complete CPET: less than or equal to 70% predicted distance on the 6MWT

*major cancer surgery in this study is defined as abdominal cancer surgeries with an anticipated duration of >2 hours and anticipated length of hospital stay of >1 night.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• Myocardial infarction in the last 3 months or unstable angina
• Cerebrovascular event or transient ischemic attack in the last 3 months
• Pulmonary embolic event within 3 months, existing acute or chronic deep vein thrombosis
• Pregnancy
• Presentation with active sepsis
• Planned for surgery in <2weeks
• Hospital inpatient, with anticipated admission >1 week
• Unable or contra-indication to exercise
• Unable to exercise unsupervised and the absence of appropriate supervision

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14819 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 28072 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 303854 0
Charities/Societies/Foundations
Name [1] 303854 0
Peter MacCallum Cancer Foundation
Address [1] 303854 0
305 Grattan St,
Melbourne VIC 3000
Country [1] 303854 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 303992 0
None
Name [1] 303992 0
Address [1] 303992 0
Country [1] 303992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304366 0
Peter MacCallum Cancer Centre Human Research LNR Ethics Committee (EC00235)
Ethics committee address [1] 304366 0
305 Grattan St
Melbourne, VIC 3000
Ethics committee country [1] 304366 0
Australia
Date submitted for ethics approval [1] 304366 0
13/02/2018
Approval date [1] 304366 0
03/04/2018
Ethics approval number [1] 304366 0
18/34L

Summary
Brief summary
This study aims to evaluate the feasibility of delivering an individualised exercise prehabilitation program amongst high risk surgical patients presenting for major cancer surgery.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo major abdominal cancer surgery.

Study details
Participants in this study will receive an indivdiualised exercise prehabilitation program for a period of six weeks. Potential participants are recruited through our cardiopulmonary exercise testing clinic at the Peter MacCallum Cancer Centre. Participants are then followed for a period of six weeks preoperatively and thirty days post-operatively in order to review any surgical complications, length of stay in hospital and other clinical outcomes. If preoperative exercise is feasible within this population, we may be able to implement a program for patients of high risk to lessen surgical risk post-operatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96702 0
Ms Jamie Waterland
Address 96702 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne, VIC 3000
Country 96702 0
Australia
Phone 96702 0
+61 03 8559 8223
Fax 96702 0
Email 96702 0
jamie.waterland@petermac.org
Contact person for public queries
Name 96703 0
Ms Jamie Waterland
Address 96703 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne, VIC 3000
Country 96703 0
Australia
Phone 96703 0
+61 03 8559 8223
Fax 96703 0
Email 96703 0
jamie.waterland@petermac.org
Contact person for scientific queries
Name 96704 0
Ms Jamie Waterland
Address 96704 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne, VIC 3000
Country 96704 0
Australia
Phone 96704 0
+61 03 8559 8223
Fax 96704 0
Email 96704 0
jamie.waterland@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary