Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001115325
Ethics application status
Approved
Date submitted
4/07/2017
Date registered
31/07/2017
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing Pre-prostatectomy and Post-prostatectomy Exercise Intervention for Prostate Cancer Patients.
Scientific title
Comparing the effect of either a Pre-prostatectomy and Post-prostatectomy Exercise Intervention and Assessment on Patient outcomes for Prostate Cancer Patients.
Secondary ID [1] 292342 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 303891 0
Condition category
Condition code
Cancer 303257 303257 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized controlled trial study design will be used to evaluate and compare the effectiveness of a 6- week comprehensive individually supervised pre-surgical exercise program, with assessments conducted at Edith Cowan University Exercise Medicine Institute (EMRI). The exercise group (PresurgEx) will exercise prior to surgery and receive usual care after surgery. The delay-exercise usual care control group (Delay) will only be provided with the current usual care prior to surgery and offered 6 weeks of exercise post-surgery. Testing will be conducted at baseline, pre-surgery, 6 weeks post-surgery (6PS), and 12 weeks post-surgery (12PS). In addition, a 24-hr pad test will be undertaken after discharge from hospital. The Delay group will start exercise after 6PS. The intervention involves resistance (chest press, leg press, seated row, leg curls, leg extension, bicep curls, and calf raises) and aerobic training (Treadmill) undertaken thrice weekly in an exercise setting. Patients will be invited to participate by their attending specialists, who are part of this project. This replicates an existing collaboration between EMRI and the urologist at the participating hospitals. Information about the program will be provided and those that express interest will be contacted by the research team. A sample size calculation (2-tailed, alpha = 0.05 and power = 95%) based on expected effect size differences in muscle strength reported in previous studies and using G*Power indicated that each group requires a sample of 16 participants. It is estimated that we will be able to recruit approximately 20 participants per group (factoring in a 30% attrition rate) over a one year period. The eligibility criteria to participate includes: localised PCa; at least seven weeks between diagnosis of cancer and surgery date; absence of any acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit the ability to walk 400m unassisted and undertake upper- and lower-body exercise; medically cleared by their physician; and written consent.

Exercise intervention
Each supervised exercise session will be ~90 minutes in duration. Sessions will commence with a 5-minute warm-up consisting of a moderate level of aerobic exercise (~60% heart rate maximum (HRmax)), as well as stretching exercises of the major muscle groups. This will be followed by a previously used resistance-training regime targeting upper- and lower-limb exercises. Progression of resistance exercise will follow guidelines previously outlined. Specifically, training phases were: 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 15 minutes of exercises focusing on the trunk stabilising muscles which includes three sets of three different exercises [planks (anterior abdominals), reverse bridge on Swiss ball (back extensors) and side planks (oblique abdominals)] with a rest of 30 to 60 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 5-minute cool-down. All sessions will be conducted by an accredited exercise physiologist (RA) to ensure safety and adherence (number of sessions attended, number of sessions missed will be compiled).
Intervention code [1] 298520 0
Prevention
Intervention code [2] 298610 0
Treatment: Other
Comparator / control treatment
Delay exercise usual care control group (Delay)
The delay-exercise usual care control group (Delay) will only be provided with the current usual care prior to surgery (no activity specifically prescribed) and offered 6 weeks of exercise post-surgery. This group will receive the current standard practice prior to surgery and information on performing exercises on the trunk stabilising muscles similar to the exercise intervention. Testing will be conducted at baseline, pre-surgery, 6 weeks post-surgery (6PS), and 12 weeks post-surgery (12PS). In addition, a 24-hr pad test will be undertaken after discharge from hospital. The Delay group will be provided an option to partake in the above described exercise intervention after the 6PS assessment session.
Control group
Active

Outcomes
Primary outcome [1] 302632 0
Physical Function assessed by one repetition strength test and Physical function test.
Timepoint [1] 302632 0
Testing will be conducted at baseline, pre-surgery, 6 weeks post-surgery (6PS) (Primary time point), and 12 weeks post-surgery (12PS).
Primary outcome [2] 302837 0
DEXA Scan measured by Body composition
Timepoint [2] 302837 0
Testing will be conducted at baseline, pre-surgery, 6 weeks post-surgery (6PS) (Primary time point), and 12 weeks post-surgery (12PS).
Secondary outcome [1] 336573 0
quality of Life assessed by SF-36
Timepoint [1] 336573 0
Testing will be conducted at baseline, pre-surgery, 6 weeks 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
Sex
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 proposed sample size will allow for the determination of an effect size of d = 0.5 used to examine clinically meaningful changes across time. The main outcomes measured in this trial will be analyzed 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. An intention-to-treat approach will be used for all analyses with maximum likelihood imputation of missing values (expectation maximisation). All 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). Statistical significance will be set at an alpha level of 0.05. The effect size (ES) will be calculated for all results: ES = (MeanPost - MeanPre/SDPre).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/10/2016
Date of last participant enrolment
Anticipated
19/12/2018
Actual
30/01/2019
Date of last data collection
Anticipated
21/05/2019
Actual
21/02/2019
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8472 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [2] 8473 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [3] 8474 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 16557 0
6150 - Murdoch
Recruitment postcode(s) [2] 16558 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 296891 0
University
Name [1] 296891 0
Edith Cowan University
Country [1] 296891 0
Australia
Primary sponsor type
Individual
Name
Favil Singh
Address
270 Joondalup Drive
Joondalup 6027
WA
Country
Australia
Secondary sponsor category [1] 295897 0
None
Name [1] 295897 0
Address [1] 295897 0
Country [1] 295897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298110 0
Edith Cowan University HREC
Ethics committee address [1] 298110 0
270 Joondalup Drive
Joondalup 6027
WA
Ethics committee country [1] 298110 0
Australia
Date submitted for ethics approval [1] 298110 0
Approval date [1] 298110 0
03/03/2016
Ethics approval number [1] 298110 0
Project #14320
Ethics committee name [2] 298111 0
South Metropolitan Health Service-Research Ethics&Governance
Ethics committee address [2] 298111 0
Level 3
Southern Research Facility (Perkins Building)
11 Robin Warren Drive
Murdoch 6150
WA
Ethics committee country [2] 298111 0
Australia
Date submitted for ethics approval [2] 298111 0
Approval date [2] 298111 0
13/12/2016
Ethics approval number [2] 298111 0
2016-171

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. First group will receive a 6- week comprehensive supervised pre-surgical exercise program consisting of progressive resistance and aerobic exercise. 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 an option to partake in the exercise intervention at completion of 6 weeks post-surgery assessments.
Testing will be conducted at baseline, pre-surgery, 6 weeks post- surgery (6PS), and 12 weeks post-surgery (12PS). In addition, a 24-hr pad test will be undertaken after discharge from hospital.

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
All current recruited participant are referred from private urologist and they are only recruited after the approval of ethics from Edith Cowan University. The second Ethic approval on a later date is from South Metropolitan Health Service-Research Ethics & Governance which governs the public hospitals. No study participant has been recruited from Fiona Stanley Hospital which falls under the South Metropolitan Health Service-Research Ethics & Governance.

Contacts
Principal investigator
Name 76026 0
Dr Favil Singh
Address 76026 0
Exercise Medicine Research Institute
Building 21
Edith Cowan University
270 Joondalup Drive
Joondalup WA, 6027
Country 76026 0
Australia
Phone 76026 0
+61 8 63042369
Fax 76026 0
Email 76026 0
[email protected]
Contact person for public queries
Name 76027 0
Favil Singh
Address 76027 0
Exercise Medicine Research Institute
Building 21
Edith Cowan University
270 Joondalup Drive
Joondalup WA, 6027
Country 76027 0
Australia
Phone 76027 0
+61 8 63042369
Fax 76027 0
Email 76027 0
[email protected]
Contact person for scientific queries
Name 76028 0
[email protected]
Address 76028 0
Exercise Medicine Research Institute
Building 21
Edith Cowan University
270 Joondalup Drive
Joondalup WA, 6027
Country 76028 0
Australia
Phone 76028 0
+61 8 63042369
Fax 76028 0
Email 76028 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
The data will only be share with the participant only and not share to the public.


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.