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Trial registered on ANZCTR


Registration number
ACTRN12618000688280
Ethics application status
Approved
Date submitted
9/04/2018
Date registered
27/04/2018
Date last updated
1/08/2019
Date data sharing statement initially provided
1/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Supervised exercise program versus a home exercise program for cancer patients, prior to undergoing prostate surgery.
Scientific title
Supervised versus home-based exercise prior to surgery to improve physical function for prostate cancer patients scheduled for prostatectomy.
Secondary ID [1] 294550 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Singh, F., et al. (2017). "Feasibility of Presurgical Exercise in Men With Prostate Cancer Undergoing Prostatectomy." Integr Cancer Ther 16(3): 290-299.

ACTRN12615000731594.

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 307326 0
Condition category
Condition code
Cancer 306434 306434 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised 2 group study design will be used to evaluate and compare the effectiveness of a 6-week supervised gym-based exercise program to a home-based program undertaken prior to surgery, with assessments being conducted at the Edith Cowan University Exercise Medicine Research Institute (EMRI). The gym-based exercise group (Ex) will be provided with the exercise training undertaken thrice weekly in an exercise setting and the home-based exercise group (HB) will be provided with an exercise information booklet and information on a 6-week home-based exercise program with weekly telephone calls. Assessments will be conducted at baseline, pre-surgery, and 6-weeks post-surgery. In addition, a 24-hr pad test will be undertaken after patients are discharged from hospital and have had their urinary catheter removed and subsequently at 6 and 12-weeks post-surgery. Patients will be invited to participate by their attending urologists from the Perth Urology Clinic. This replicates an existing collaboration between EMRI and the urologists at the participating clinic. Information about the program will be provided and those that express interest will be contacted by the research team.

Ex group:
Exercise sessions will be ~60 minutes, commencing with a warm-up consisting of a moderate level of aerobic exercise [~60% heart rate maximum (HRmax)]. Resistance-training regime targeting upper- and lower-limb exercises (chest press, leg press, seated row, leg curls, leg extension, bicep curls, and calf raises) will be conducted. Progression of resistance exercise will follow guidelines previously outlined: week 1 – 2 (two sets 12 repetition maximum (RM)), week 3 (three sets of 10 RM), week 4 – 5 (three sets of 8 RM), and week 6 (four sets of 6 RM). This will be followed by 10 minutes of exercises focusing on the trunk stabilising muscles which include three sets of three different exercises [planks (anterior abdominals), the reverse bridge on a Swiss ball (back extensors) and side planks
(oblique abdominals)] with a rest of 30 seconds between sets. Finally, the session will conclude with 20 minutes of aerobic exercise at 60 – 80% (intensity) of the estimated HRmax (220 – age in years) followed by a cool down. Participants will be asked to complete further aerobic sessions to meet the 150 minutes per week aerobic guidelines which would be monitored by a participant diary. All sessions will be supervised by an accredited exercise physiologist to ensure safety and adherence.
Intervention code [1] 300845 0
Prevention
Comparator / control treatment
Home-based group:
This group will receive an exercise information booklet and will be requested to complete at least 150 minutes of aerobic exercise per week in sessions of 20 minutes or more and 2-4 sets of 10-12 repetitions of body weight resistance exercises (push-ups, chair dips) and exercises using a gym stick (biceps, squats, leg extension, calf raises, seated-rows) at least three times per week. Home-based participants will be informed that in order to assist them in adhering to the exercise, they will be receiving weekly telephone calls from the accredited exercise physiologist, during which time they can discuss their exercise activity and any study related questions. The exercise booklet contains generic information about physical activity, health benefits of exercise, methods of measuring exercise intensity, and a logbook section. Only the initial exercise session will be conducted by the AEP to demonstrate exercises. Information on performing exercises on the trunk stabilising muscles similar to the exercise intervention will be provided.
Control group
Active

Outcomes
Primary outcome [1] 305447 0
Physical Function assessed by one repetition strength test and Physical function test.
Timepoint [1] 305447 0
Testing will be conducted at baseline, pre-surgery, 6 weeks post-surgery (6PS) (Primary time point).
Primary outcome [2] 305448 0
DEXA Scan measured by Body composition
Timepoint [2] 305448 0
Testing will be conducted at baseline, pre-surgery, 6 weeks post-surgery (6PS) (Primary time point)
Secondary outcome [1] 345276 0
Quality of Life by EORTC QLQ-C30
Timepoint [1] 345276 0
Testing will be conducted at baseline, pre-surgery, 6 weeks post-surgery (6PS).
Secondary outcome [2] 345277 0
urinary Incontinence by 24hrs pad tests measurements
Timepoint [2] 345277 0
Testing will be conducted at immediately after surgery, 6weeks post-surgery (6PS), and 12 weeks post-surgery (12PS).

Eligibility
Key inclusion criteria
Inclusion criteria
1. Localised prostate cancer.
2. Have at least seven weeks between diagnosis of cancer and surgery date.
3. No acute illness, musculoskeletal, cardiovascular or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise.
4. Ability to walk 400m unassisted and undertake upper- and lower-body exercise.
5. Not be performing regular exercise defined as undertaking structured aerobic or resistance training two or more times per week within the past 3 months.
6. Be able to read and speak English.
Minimum age
45 Years
Maximum age
80 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) metastasised cancer patient
2) any illness and inability to walk 400m unassisted
3) patient undertaking structured resistance exercise

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The main outcomes measured will be analysed using MANOVA, comparing changes within and between groups. Where appropriate, posthoc testing with Holm-Bonferroni adjustment will be employed to locate the source of significant difference. The intention-to-treat approach will be used for all analyses with maximum likelihood imputation of missing values (expectation maximisation). Results will be recorded as mean + SD, and the size of change and precision will be provided by reporting the change in mean values and the 95% confidence intervals (95%CI). P-values will be two-sided, with P<0.05 considered statistically significant. The Kolmogorov-Smirnov test will be used to check whether the outcome variables follow a normal distribution.

Recruitment
Recruitment status
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)
WA
Recruitment hospital [1] 10612 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [2] 10613 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 22328 0
6150 - Murdoch
Recruitment postcode(s) [2] 22329 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 299175 0
Charities/Societies/Foundations
Name [1] 299175 0
Cancer Council WA
Address [1] 299175 0
420 Bagot Road, Subiaco WA 6008
Country [1] 299175 0
Australia
Primary sponsor type
Individual
Name
Favil Singh
Address
Edith Cowan University
270 Joondalup Drive
Joondalup 6027
WA
Country
Australia
Secondary sponsor category [1] 298431 0
None
Name [1] 298431 0
Address [1] 298431 0
Country [1] 298431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300097 0
Edith Cowan University Ethic Committee
Ethics committee address [1] 300097 0
270 Joondalup Drive
Joondalup 6027
WA
Ethics committee country [1] 300097 0
Australia
Date submitted for ethics approval [1] 300097 0
01/03/2018
Approval date [1] 300097 0
21/05/2018
Ethics approval number [1] 300097 0

Summary
Brief summary
This study aims to evaluate the effectiveness of a 6- week comprehensive supervised pre-surgical exercise program in prostate cancer patients scheduled for prostatectomy.

Who is it for?
You may be eligible to join this study if you are a male aged between 45 and 80 years of age and have been diagnosed with localised prostate cancer with at least seven weeks to until scheduled surgery date.

Study details
Study participants will be allocated by chance to one of the two groups. The first group will receive a 6- week comprehensive supervised pre-surgical exercise program consisting of progressive resistance and aerobic exercise. The second group will receive usual care during the pre-surgery period along with information on performing exercises on the trunk stabilising muscles similar to the exercise intervention. This group will be provided with an option to partake in the home-exercise intervention of 6 weeks prior to surgery.

Testing will be conducted at baseline, pre-surgery and 6 weeks post- surgery (6PS). Testing will involve, strength and aerobic tests, a body scan, questionnaires and a 24-hr pad test. In addition, a 24-hr pad test will be undertaken after discharge from hospital and at the 12 weeks after surgery.

This research is a critical step in a series of studies required to determine the most effective and efficient ways to maximize prostate cancer patient health and therefore lay the foundation for future research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82558 0
Dr Favil Singh
Address 82558 0
Exercise Medicine Research Institute
Building 21
Edith Cowan University
270 Joondalup Drive
Joondalup WA, 6027
Country 82558 0
Australia
Phone 82558 0
+61 8 63042369
Fax 82558 0
Email 82558 0
f.singh@ecu.edu.au
Contact person for public queries
Name 82559 0
Dr Favil Singh
Address 82559 0
Exercise Medicine Research Institute
Building 21
Edith Cowan University
270 Joondalup Drive
Joondalup WA, 6027
Country 82559 0
Australia
Phone 82559 0
+61 8 63042369
Fax 82559 0
Email 82559 0
f.singh@edu.adu.au
Contact person for scientific queries
Name 82560 0
Dr Favil Singh
Address 82560 0
Exercise Medicine Research Institute
Building 21
Edith Cowan University
270 Joondalup Drive
Joondalup WA, 6027
Country 82560 0
Australia
Phone 82560 0
+61 8 63042369
Fax 82560 0
Email 82560 0
f.singh@edu.adu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 3672 0
Informed consent form
Citation [1] 3672 0
Link [1] 3672 0
Email [1] 3672 0
Other [1] 3672 0
Summary results
No Results