Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000777897
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
22/06/2021
Date last updated
29/07/2022
Date data sharing statement initially provided
22/06/2021
Date results information initially provided
23/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise Medicine Prior to Open Radical Cystectomy in Adults with Bladder Cancer
Scientific title
Exercise Medicine Prior to Open Radical Cystectomy in Adults with Bladder Cancer: Feasibility and Preliminary Efficacy
Secondary ID [1] 303838 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 321374 0
Condition category
Condition code
Cancer 319148 319148 0 0
Bladder
Physical Medicine / Rehabilitation 319149 319149 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Up to a 4-week supervised exercise program with a minimum of 2 weeks (based on scheduling for surgery) consisting of moderate- to high-intensity resistance- and aerobic-based training will be implemented for those having cystectomy only. For those undergoing chemotherapy prior to surgery,
the exercise program will be for the duration of chemotherapy which is usually for about 12 weeks. Supervised training will be undertaken 3 times per week for approximately 1 hour each session with a home program of walking 2 or more days per week that consists of 
20-30 minutes of activity. For those undergoing neo-adjuvant chemotherapy, supervised training sessions will be undertaken twice weekly. The sessions will be predominantly one-on-one with an accredited exercise physiologist (AEP) given that time to surgery and patient availability will determine timing of the training sessions. The exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention. Resistance exercise will involve 6-8 exercises that target the major upper and lower body muscle groups, such as the chest 
press, seated row, shoulder press, leg press, leg extension, leg curl, biceps curl and triceps extension. Intensity will be manipulated from 6-12 repetition maximum (RM; i.e. the 
maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-3 sets per exercise. 
The aerobic exercise component will include ~20 minutes (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. Sessions will 
commence and conclude with a 5-minute warm-up and cool-
down consisting of low level aerobic activities and stretching.  The training sessions will take place at the Vario Exercise Clinic in the Exercise Medicine Research Institute 
(EMRI) at Edith Cowan University in Joondalup (north of Perth CBD) and at our new EMRI exercise clinic at Fiona Stanley Hospital (South of Perth CBD).
Attendance will be noted based on attendance sheets and participant activity log.
Intervention code [1] 320142 0
Lifestyle
Intervention code [2] 320143 0
Rehabilitation
Intervention code [3] 320144 0
Treatment: Other
Comparator / control treatment
No control group. This is a single-armed pilot study trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327024 0
Feasibility (composite primary outcome) 1) recruitment and completion rates (the investigators will record and perform data analysis on the total number of participants referred, number of participants that are eligible for the study, number of participants that have been enrolled into the study, number of participant withdrawals from the study, trial recruitment rate, trial completion rate), 2) patient safety (number and severity of adverse events - patients are supervised at all times by an accredited exercise physiologist to ensure all the exercises are performed with correct technique and in a safe manner; participant-reported adverse events are recorded in and signed off by the trial coordinator), 3) program tolerance (the participant will record their sessional rating of perceived exertion (RPE) using the Borg 6-20 scale after every exercise session), 4) program adherence (the number of completed sessions, number of missed sessions by each participant will be recorded and calculated during data analysis), and 5) program compliance (the number of prescribed versus actual exercise completed, % of total volume completed will be recorded and calculated during data analysis). Reasons for refusal and barriers to participate, withdrawal, missed sessions and non-compliance will be investigated, as will the patient’s views on changes/improvements to the exercise regimen and session format. These will be determined by telephone between the accredited exercise physiologist and participant and discussed with the investigators.
Timepoint [1] 327024 0
Recruitment and completion rates will be assessed at the end of the study as will participant safety, program tolerance, program adherence and compliance. Reasons for refusal will be determined within one week of refusal.
Secondary outcome [1] 396035 0
Length of hospital stay
Length of hospital stay will be obtained from hospital records
Timepoint [1] 396035 0
3-months post-surgery
Secondary outcome [2] 396036 0
Complications (up to 3 months post-surgery) will be obtained from hospital records with comparison (including use of Clavien Classification of surgical complications) to a prospectively collected radical cystectomy patient series
at a single institution from CI-Professor Hayne.
Timepoint [2] 396036 0
3-months post-surgery
Secondary outcome [3] 396037 0
Physical function (composite secondary outcome)
Physical function will be assessed prior to exercise, pre-surgery and 3-months post-surgery via a battery of standard tests we have used extensively that include:
1) one-repetition maximum (1RM) strength for the chest press and leg press which represents upper- and
lower-body muscle strength, respectively,
2) 6-minute walk test (6MWT) as a validated sub-maximal
surrogate measure for VO2 max (aerobic capacity or aerobic fitness),
3) repeated chair rise (time to rise from a chair 5 times as a measure of lower body muscle function), and
4) the get-up-and-go test
to assess agility and dynamic balance.
Timepoint [3] 396037 0
Week 0 (baseline), pre-surgery (following completion of intervention), 3-month follow-up post-surgery
Secondary outcome [4] 396038 0
Quality of life
Health-related quality of life will be assessed using the Medical Outcomes Short Form 36 (SF-36), which assesses patient-rated physical and mental health outcomes across the domains of physical function, role function (physical, emotional), bodily pain, general health, vitality (encompassing energy level and fatigue), social functioning and mental health.
Bladder cancer specific quality of life will be assessed using the Functional
Assessment of Cancer Therapy – Bladder (FACT-Bl) which includes additional questions covering urinary and bowel function, sexual symptoms and body image.
Timepoint [4] 396038 0
Week 0 (baseline), pre-surgery (following completion of intervention), 3-month follow-up post-surgery
Secondary outcome [5] 396039 0
Psychological distress
The Brief Symptom Inventory-18 (BSI-18) will be utilised to assess psychological distress across the domains of anxiety, depression, somatisation, and global distress severity
Timepoint [5] 396039 0
Week 0 (baseline), pre-surgery (following completion of intervention), 3-month follow-up post-surgery
Secondary outcome [6] 396040 0
Body image
Body image will be specifically assessed using the 10-
item Body Image Scale (BIS)
Timepoint [6] 396040 0
Week 0 (baseline), pre-surgery (following completion of intervention), 3-month follow-up post-surgery
Secondary outcome [7] 396041 0
Body composition.
Whole body and regional lean mass and fat mass will be derived from a whole body dual-energy X-ray absorptiometry (DXA) scan
Timepoint [7] 396041 0
Week 0 (baseline), pre-surgery (following completion of intervention), 3-month follow-up post-surgery
Secondary outcome [8] 396042 0
Return to work or usual activities
Return to work and usual activities will be assessed using the Resumption of Activities of Daily Living (RADL) Scale, modified for time since surgery. The extent to which the patient has resumed their normal activities (scale from 0% to 100%) in the areas of selfcare, household chores, shopping, socialising, recreation, and paid employment (if applicable) will be assessed at 3 months post-surgery.
Timepoint [8] 396042 0
3-months post-surgery
Secondary outcome [9] 396043 0
Demographics, lifestyle behaviours, and health history will be obtained by questionnaire and medical records.
Height and weight will be measured using a stadiometer and electronic scales, respectively. Self-reported physical activity will be assessed at pre-exercise, pre-surgery and 3-months post-surgery by the Leisure Score Index from the Godin Leisure-Time Exercise Questionnaire as will nutritional status by the Mini Nutritional Assessment
Timepoint [9] 396043 0
Week 0 (baseline), pre-surgery (following completion of intervention), 3-month follow-up post-surgery

Eligibility
Key inclusion criteria
Twenty patients scheduled to undergo RC will be recruited by invitation from their attending Urologist (CI-Professor Hayne and CI-Dr La Bianca). Potential patients will be those with 
muscle-invasive bladder cancer (greater than or equal to T2), patients with high-risk non-muscle-invasive bladder cancer (NMIBC) with atypical pathologic features (e.g., nested variant, micropapillary, etc.) or who prefer upfront cystectomy, those undertaking 
salvage cystectomy after failed curative intent treatment with external beam radiation therapy (EBRT) and those undergoing chemotherapy prior to surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include musculoskeletal, cardiovascular or neurological conditions that could inhibit patients from exercising.  

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/05/2018
Date of last participant enrolment
Anticipated
1/11/2021
Actual
30/03/2021
Date of last data collection
Anticipated
Actual
30/11/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 33592 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 308233 0
Charities/Societies/Foundations
Name [1] 308233 0
ANZUP Cancer Trials Group Limited
Country [1] 308233 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Building 21, Level 2, 270 Joondalup Drive, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 309026 0
Charities/Societies/Foundations
Name [1] 309026 0
ANZUP Cancer Trials Group Limited
Address [1] 309026 0
Lifehouse, Level 6, 119-143 Missenden Road, Camperdown NSW 2050
Country [1] 309026 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308215 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 308215 0
South Metropolitan Health Service Executive
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 308215 0
Australia
Date submitted for ethics approval [1] 308215 0
Approval date [1] 308215 0
01/02/2018
Ethics approval number [1] 308215 0

Summary
Brief summary
This study is investigating whether it is feasible to administer an exercise program prior to radical surgery for patients with bladder cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have been diagnosed with bladder cancer, you will be undergoing radical open cystectomy and you have been invited to participate in the program by one of the investigating urologists who are based in Western Australia (Professor Hayne and Dr La Bianca). Participants who are not being treated in Western Australia will not be eligible for this study.

Study details
Participants who are invited to participate in this study will be prescribed an exercise program to be completed 2-3 times each week for a maximum of 4 weeks, dependent upon when their surgery has been scheduled, for cystectomy only and for those undergoing neo-adjuvant chemotherapy for approximately 12 weeks. Participants will undergo one-on-one training with an exercise physiologist for 2-3 one hour sessions each week, and will also be asked to complete another 20-30 minute exercise sessions (e.g. walking) on the other 2 days at home. The supervised sessions will involve two types of exercise, resistance training that may involve lifting weights or performing strength exercises, and aerobic training that may involve walking or jogging on a treadmill, cycling or rowing on a stationary machine. The exercise regime will finish prior to your scheduled surgery. You will be asked to complete a series of questionnaires before starting the exercise program, after completing the program, and 3 months after your surgery.

It is hoped this research will demonstrate that a pre-surgical exercise program is safe and feasible to deliver to patients with bladder cancer, and that the exercise program may improve post-operative outcomes in these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109962 0
Prof Dennis Taaffe
Address 109962 0
Building 21, Level 2
Exercise Medicine Research Institute,
Edith Cowan University
270 Joondalup Drive.
JOONDALUP, Perth, WA 6027.
Country 109962 0
Australia
Phone 109962 0
+61 8 6304 5476
Fax 109962 0
Email 109962 0
[email protected]
Contact person for public queries
Name 109963 0
Miss Christine Kudiarasu
Address 109963 0
Building 21, Room 217
Exercise Medicine Research Institute,
Edith Cowan University
270 Joondalup Drive.
JOONDALUP, Perth, WA 6027.
Country 109963 0
Australia
Phone 109963 0
+61 8 6304 6089
Fax 109963 0
Email 109963 0
[email protected]
Contact person for scientific queries
Name 109964 0
Miss Christine Kudiarasu
Address 109964 0
Building 21, Room 217
Exercise Medicine Research Institute,
Edith Cowan University
270 Joondalup Drive.
JOONDALUP, Perth, WA 6027.
Country 109964 0
Australia
Phone 109964 0
+61 8 6304 6089
Fax 109964 0
Email 109964 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11223Study protocol    Study protocol attached 381726-(Uploaded-30-03-2021-16-44-08)-Study-related document.pdf



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.