Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000814875
Ethics application status
Approved
Date submitted
21/04/2021
Date registered
28/06/2021
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapy Prehabilitation for cancer surgery patients.
Scientific title
Does Physiotherapy led exercise Prehabilitation reduce cancer surgery patients’ length of stay and risk of post-operative complications?
Secondary ID [1] 304022 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 321653 0
Elective upper abdominal surgery 321949 0
Upper gastrointestinal cancer 321950 0
Complex bowel cancer 321951 0
Sarcoma 321952 0
Condition category
Condition code
Cancer 319400 319400 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 319401 319401 0 0
Oesophageal (gullet)
Cancer 319402 319402 0 0
Pancreatic
Cancer 319403 319403 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will participate in an initial assessment conducted by a senior physiotherapist to determine baseline exercise tolerance and other descriptors. This includes a 6 minute walking test (6MWT) and a balance/frailty assessment called a short physical performance battery (SPPB). A quality of life survey (QLQ C30) will also be assessed at this time.

They will then participate in a 2x weekly, one hour in length duration tailored supervised exercise program. This is conducted by a senior physiotherapist and 4th year physiotherapy students from Curtin University.

Participants recruited may be currently receiving neoadjuvant chemoradiotherapy (CRT), have finished CRT on not completing CRT. The intervention is carried out despite their current CRT as to not impact on their cancer care. It has already been proven that exercise is safe at any point within the patients' treatment journey and this is why this approach was taken.

The program will consist of a walking program (determined from their 6MWT result) and resistance exercises via standard gymnasium equipment. The program is run as a group class, with a maximum of 10 participants per class.

Their program will be documented and progressed / regressed as deemed appropriate by the supervising physiotherapist. The participants will be asked to exercise at a 'moderate intensity' which is described as 'difficulty walking and talking'. The walking program is implemented on a flat walking track within the hospital, and resistance exercises are completed on standard gymnasium equipment in the Physiotherapy gym. These include, upper limb exercise with free weights, sit to stand, step ups, calf raises, body weight push up, large muscle group exercise on gym equipment (leg press, latissimus dorsi pull down, tricep push, Smith machine etc).

At the end of the 6 week program, the physiotherapist will repeat the initial assessment as a discharge assessment. As patients CRT treatment time / time to surgery differs for each surgical group - patients attend the surgical gym class for 6 weeks which is usually between 1-2 weeks pre-op. Adherence to the program is monitored via WebPAS - on online booking system used by the Physiotherapy clerks. Adherence is measured as appointments attended.

Once the patient is discharged from hospital, we will record the patients’ length of stay in ICU and in hospital and post-operative complications occurred during their inpatient stay. If required, medical records will be pulled to allow for data collection.
Intervention code [1] 320342 0
Treatment: Other
Intervention code [2] 320343 0
Rehabilitation
Intervention code [3] 320344 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327264 0
Exercise tolerance in meters, assessed using 6-minute walk test (6MWT)
Timepoint [1] 327264 0
Following completion of a 6 week Prehabilitation exercise program compared to pre-completion of the program
Secondary outcome [1] 394386 0
Frailty, assessed using the Short Physical Performance Battery
Timepoint [1] 394386 0
Following completion of a 6 week Prehabilitation exercise program compared to pre-completion of the program
Secondary outcome [2] 394387 0
Strength, assessed using a hand grip dynamometer
Timepoint [2] 394387 0
Following completion of a 6 week Prehabilitation exercise program compared to pre-completion of the program
Secondary outcome [3] 394388 0
Quality of Life, assessed using “EORTC QLQ-C30” survey
Timepoint [3] 394388 0
Following completion of a 6 week Prehabilitation exercise program compared to pre-completion of the program
Secondary outcome [4] 394389 0
Length of stay in ICU (days), assessed via accessing patient's medical record
Timepoint [4] 394389 0
At discharge from ICU
Secondary outcome [5] 394390 0
Time to mobilise out of bed post-operatively (days), assessed via accessing patient's medical record
Timepoint [5] 394390 0
Post-surgery
Secondary outcome [6] 394391 0
Rate of post-operative pulmonary complications (PPC’s) as measured by the Melbourne Group Scale (MGS) diagnostic scoring tool.
Timepoint [6] 394391 0
PPC's will be recorded throughout the patients inpatient stay until discharge from hospital
Secondary outcome [7] 394392 0
Length of stay in hospital (days), assessed via accessing patient's medical record
Timepoint [7] 394392 0
At hospital discharge

Eligibility
Key inclusion criteria
All patients scheduled for complex surgery for cancer (upper gastrointestinal (UGI), complex bowel, sarcoma) will be eligible for inclusion into the program.
Patients who are assessed as deconditioned with a low pre surgical exercise tolerance and mobility level
Patients planned for complex surgery and planned long anaesthetic time
Any patient confirmed as borderline on cardiopulmonary exercise testing (CPET) who would benefit from exercise training
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if their surgery is scheduled for sooner than six weeks
Patients who are neutropenic
People who cannot speak English
Patients who are unable to cognitively participate in a group exercise program
Patients over 150kg which is the safe working limit of the gym equipment
Any patients who are deemed ‘too high risk’ for UAS
People highly dependent on medical care who may be unable to give consent
People with cognitive impairment, an intellectual disability or a mental illness
People in other countries

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation (G*Power) has determined that a minimum of n=38 participants has 80% power (alpha=0.05) to detect an average 25m improvement (Standard deviation (SD)=60) in the 6MWT (primary outcome measure). This sample is adequate for a repeated measures analysis over two time points in one group with 3 covariates.

Descriptive statistics of baseline demographic variables, pre and post-op measures will include means and SDs or medians and interquartile range (IQR), depending on normality, for continuous data, and frequency distributions for categorical data. Univariate differences in pre-operative pre-post measures from Phase 1 (Prehabilitation exercise program phase) will be assessed using t tests or Mann-Whitney U tests for continuous data and chi-squared tests for categorical data. Linear mixed models with random subject effects (to take into account between subject differences at baseline) will be used to examine pre-post mean changes in 6MWT and other secondary outcomes including frailty, strength and QOL outcomes. Length of stay (LOS) in ICU and hospital and days to mobilisation will be examined using Kaplan-Meier survival analysis and Cox regression models. Post-op PPC indicators in relation to fitness (6MWT improvement) will be examined using logistic regression models. All models will be adjusted for age, sex, pre-surgical chemotherapy. Data analysis will be done using Stata 16.0 (StataCorp, College Station, TX). P-values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/09/2020
Date of last participant enrolment
Anticipated
19/11/2021
Actual
Date of last data collection
Anticipated
7/01/2022
Actual
Sample size
Target
38
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19174 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 33746 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 308408 0
Hospital
Name [1] 308408 0
Sir Charles Gairdner Hospital
Country [1] 308408 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 309239 0
None
Name [1] 309239 0
Address [1] 309239 0
Country [1] 309239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308367 0
Sir Charles Gairdner Osborne Park Health Care Group (SCGHOPHG) Human Research Ethics Committee (HREC)
Ethics committee address [1] 308367 0
Ethics committee country [1] 308367 0
Australia
Date submitted for ethics approval [1] 308367 0
26/11/2019
Approval date [1] 308367 0
25/06/2020
Ethics approval number [1] 308367 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110462 0
Ms Luisa Perrella
Address 110462 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands WA 6009.
Country 110462 0
Australia
Phone 110462 0
+61 8 64572337
Fax 110462 0
Email 110462 0
[email protected]
Contact person for public queries
Name 110463 0
Luisa Perrella
Address 110463 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands WA 6009.
Country 110463 0
Australia
Phone 110463 0
+61 8 64572337
Fax 110463 0
Email 110463 0
[email protected]
Contact person for scientific queries
Name 110464 0
Luisa Perrella
Address 110464 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands WA 6009.
Country 110464 0
Australia
Phone 110464 0
+61 8 64572337
Fax 110464 0
Email 110464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant information is kept confidential and de-identified once data is collected as per hospital ethics committee guidelines


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
No additional documents have been identified.