Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000731594
Ethics application status
Approved
Date submitted
30/06/2015
Date registered
16/07/2015
Date last updated
9/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beneficial effects of exercise done before prostate cancer surgery
Scientific title
Feasibility of Presurgical Exercise in Men With Prostate Cancer Undergoing Prostatectomy
Secondary ID [1] 287021 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 295488 0
Condition category
Condition code
Cancer 295743 295743 0 0
Prostate
Surgery 295799 295799 0 0
Other surgery
Physical Medicine / Rehabilitation 295800 295800 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was a 6-week exercise intervention programme with assessments undertaken at three time-points: (1) baseline, (2) immediately pre-surgery and (3) 6-week post-surgery follow-up. The 6-week exercise programme commenced 6 weeks prior to the schedule surgery date. Patients undertook an exercise programme that consisted of two supervised clinic sessions per week. Each supervised exercise session took approximately 90 minutes to complete. Sessions commenced with a 5-minute warm-up consisting of moderate level of aerobic exercise (~60% heart rate maximum (HRmax)), as well as stretching exercises of the major muscle groups: chest, shoulder, biceps, triceps, quadriceps, hamstrings and calf muscles. This was followed by a resistance-training regime that included a series of six exercises targeting the major muscles of the upper- and lower-body. Upper-limb exercises included chest press, seated row and lat pull-down. Lower-limb exercises were leg extension, leg curl and leg press. All exercises were performed through the full range of motion adhering to correct techniques. To ensure the progressive nature of the training programme, patients were encouraged to work past the repetition maximum (RM) prescribed, with resistance increased by 5 – 10% for the subsequent set/training sessions if they were able to exceed the number specified. Specifically, training phases were: week 1 – 2 (two sets 12 RM), week 3 (three sets of 10 RM), week 4 – 5 (three sets of 8 RM), week 6 (four sets of 6 RM). Each supervised session also included 15 minutes of exercises focusing on the trunk stabilising muscles. Patients performed three sets of three different exercises with a rest of 30 to 60 seconds between each set. These exercises consisted of planks (anterior abdominals), reverse bridge on Swiss ball (back extensors) and side planks (oblique abdominals) (Lehman, Hoda, & Oliver, 2005). The training load increased progressively by 5 – 10 seconds every week, starting with 10 seconds for the side planks and 30 seconds for the other trunk stabiliser exercises. Following the completion of the trunk stabiliser exercises, a further 20 minutes of aerobic exercise was undertaken. This included such specific activity as walking or jogging on a treadmill; cycling or rowing on a stationary ergometer; or exercising on a cross training machine depending on each patient’s preference. The target intensity was 60 – 80% of the estimated HRmax (220 – age in years) measured using heart rate monitors. The design criteria for the exercise intervention programme were to optimise the stimulus to the cardiovascular and neuromuscular systems while maximising compliance and retention. All sessions were conducted with one-on-one supervision by a qualified and accredited exercise physiologist who ensured safety and adherence to correct lifting techniques. Each session concluded with a 5-minute cool-down with stretching activities similar to the warm-up. Patients were provided with a session log in which to record their attendance, exercise weights, repetitions and sets.
Intervention code [1] 292229 0
Prevention
Intervention code [2] 292230 0
Rehabilitation
Intervention code [3] 292270 0
Lifestyle
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295462 0
The primary objective of this feasibility study was to determine the efficacy of a supervised, pre-surgical exercise programme consisting of targeted resistance and aerobic training for men with prostate cancer scheduled to receive prostatectomy. Specifically, we aimed to investigate the effects of a pre-surgical exercise intervention on neuromuscular strength using the one-repetition maximum chest press, leg press, seated row and leg extension exercise protocol.
Timepoint [1] 295462 0
Baseline, pre-surgery (after 6 weeks exercise intervention), and 6-weeks post-surgery.
Secondary outcome [1] 315615 0
We also aimed to investigate the effects of a pre-surgical exercise intervention on physical function using 400m cardiovascular aerobic test, stair climb protocol, sit and stand chair rise and 6m walking test.
Timepoint [1] 315615 0
Baseline, pre-surgery (after 6 weeks exercise intervention), and 6-weeks post-surgery.
Secondary outcome [2] 315616 0
We also aimed to investigate the effects of a pre-surgical exercise intervention on body composition using DEXA scan.
Timepoint [2] 315616 0
Baseline, pre-surgery (after 6 weeks exercise intervention), and 6-weeks post-surgery.

Eligibility
Key inclusion criteria
The eligibility inclusion criteria included at least seven weeks between diagnosis of localised prostate cancer and schedule prostatectomy date, and medical clearance to participate in an exercise programme from their general practitioner.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The eligibility exclusion criteria included presence of any acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit them from exercising.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were recruited through invitation from their attending specialist at St John of God Murdoch Medical Urology Clinic in Murdoch Hospital, Perth, Western Australia. Information pamphlets were used to publicise the research study and interested patients were informed to contact the chief researcher directly.
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
This quasi-experimental study was a 6-week exercise intervention programme with assessments undertaken at three time-points: (1) baseline, (2) immediately pre-surgery and (3) 6-week post-surgery follow-up. All assessments were conducted at Edith Cowan University Health and Wellness Institute. A timeline of six weeks was provided by the participating surgical team to conduct an exercise intervention programme as this was the approximate period between prostate cancer diagnosis and surgical intervention. The exercise sessions involved resistance and aerobic training undertaken twice weekly in an exercise setting at three different venues located in the Perth metropolitan area (Fremantle Leisure Centre, Murdoch University Sport and Recreation Centre and Southlake Leisure Centre). Edith Cowan University Human Research Ethics Committee approved the research protocol.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initially, a sample size calculation was proposed and performed for a randomised controlled study (2-tailed, alpha = 0.05 and power = 80%) based on expected effect size differences in muscle strength reported in previous studies (Galvão & Taaffe, 2005; Galvão et al., 2010). As a result, one standard deviation difference for strength was determined to be clinically meaningful, resulting in the requirement for 16 participants per group (Faul, Erdfelder, Buchner, & Lang, 2009; Faul, Erdfelder, Lang, & Buchner, 2007). Previous experience with exercise trials and cancer studies indicate an attrition rate of up to 20% (Fillion et al., 2008). Therefore, to ensure sufficient subject numbers, 20 subjects were proposed to be recruited per group. However, due to slow recruitment rate, a limited period and the time-consuming nature of such a large clinical study, the study was re-designed as a quasi-experimental study. Sixteen patients scheduled to receive prostatectomy volunteered to participate in this study. Thus the statistical power to detect change in the primary study outcomes during the 6-wk intervention ranged from 0.8 to 1.0.

All statistical analyses were performed using a statistical software program (PASW v 19 for Windows, SPSS, Inc., Chicago, IL USA). Analyses included standard descriptive statistics, paired student’s t-tests, correlation (p = 0.01), and ANOVA. Repeated-measures ANOVA was used to compare changes in the variables for the three time-points. An intention-to-treat approach was used for all analyses. We employed a last-observation-carried-forward procedure for any missing data or patients lost to post-surgery follow-up (Jones et al., 2007). Where appropriate, the post-hoc testing with Bonferroni adjustment was employed to locate the source of significant difference. All results were recorded as mean + SD, and the size of change and precision were provided by reporting the change in mean values and the 95% confidence intervals (95%CI). The effect size (ES) was calculated for all results: ES = (MeanPost - MeanPre/SDPre) (Cohen, 1988). All statistical tests were two-tailed with an alpha level of p = 0.05 set as the criterion for statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2010
Actual
21/06/2011
Date of last participant enrolment
Anticipated
Actual
1/08/2013
Date of last data collection
Anticipated
Actual
18/03/2014
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3993 0
St John of God Hospital, Murdoch - Murdoch

Funding & Sponsors
Funding source category [1] 291576 0
University
Name [1] 291576 0
Edith Cowan University
Country [1] 291576 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270, Joondalup Drive, Joondalup, WA 6027, Perth, Australia
Country
Australia
Secondary sponsor category [1] 290276 0
None
Name [1] 290276 0
Address [1] 290276 0
Country [1] 290276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300099 0
Edith Cowan University Ethic Committee
Ethics committee address [1] 300099 0
Ethics committee country [1] 300099 0
Australia
Date submitted for ethics approval [1] 300099 0
01/09/2010
Approval date [1] 300099 0
08/11/2010
Ethics approval number [1] 300099 0
4401

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

Contacts
Principal investigator
Name 58522 0
Dr Favil Singh
Address 58522 0
Edith Cowan University, School of Exercise and Health Sciences, 270, Joondalup Drive, Joondalup, WA 6027, Perth, Australia
Country 58522 0
Australia
Phone 58522 0
+61 8 63042369
Fax 58522 0
Email 58522 0
[email protected]
Contact person for public queries
Name 58523 0
Favil Singh
Address 58523 0
Edith Cowan University, School of Exercise and Health Sciences, 270, Joondalup Drive, Joondalup, WA 6027, Perth, Australia
Country 58523 0
Australia
Phone 58523 0
+61 8 63042369
Fax 58523 0
Email 58523 0
[email protected]
Contact person for scientific queries
Name 58524 0
Favil Singh
Address 58524 0
Edith Cowan University, School of Exercise and Health Sciences, 270, Joondalup Drive, Joondalup, WA 6027, Perth, Australia
Country 58524 0
Australia
Phone 58524 0
+61 8 63042369
Fax 58524 0
Email 58524 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 368866-(Uploaded-03-04-2019-16-27-05)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.