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Trial registered on ANZCTR


Registration number
ACTRN12616000582459
Ethics application status
Approved
Date submitted
26/04/2016
Date registered
5/05/2016
Date last updated
5/04/2019
Date data sharing statement initially provided
5/04/2019
Date results information initially provided
5/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pre-surgery aerobic and resistance exercise for rectal cancer patients.
Scientific title
Feasibility and Efficacy of Presurgical Exercise in Survivors of Rectal Cancer Scheduled to Receive Curative Resection
Secondary ID [1] 289077 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical treatment for rectal cancer 298526 0
Condition category
Condition code
Cancer 298613 298613 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was a 16-week exercise intervention programme done prior to surgery with assessments undertaken at three time-points: (1) baseline, (2) immediately pre-surgery and (3) 8-week post-surgery follow-up. This is a 16 weeks exercise programme that commenced prior to the schedule surgery. Patients undertook an exercise programme that consisted of two supervised clinic sessions per week. Each supervised exercise session took approximately 60 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. Progression of resistance followed guidelines previously outlined by Galvao and Newton (2005). The training phases were as follows: week 1 – 2 (two sets 12 RM), week 3 – 5 (three sets of 10 RM), week 6 – 8 (three sets of 8 RM), and week 9 – 10 (four sets of 6 RM). After week 10, the training phases set in week 1 – 2 were resumed to implement a periodised exercise model. 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] 294584 0
Prevention
Intervention code [2] 294585 0
Rehabilitation
Intervention code [3] 294586 0
Lifestyle
Comparator / control treatment
No controlled Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298103 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 rectal cancer patients scheduled to received rectal resection surgery. 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] 298103 0
Baseline, pre-surgery and 8-weeks post-surgery
Secondary outcome [1] 323188 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] 323188 0
Baseline, Pre-surgery, 8 weeks post-surgery
Secondary outcome [2] 323189 0
We also aimed to investigate the effects of a pre-surgical exercise intervention on body composition measurements such as lean mass and fat mass using the DEXA machine.
Timepoint [2] 323189 0
Baseline, pre-surgery and 8-weeks post-surgery

Eligibility
Key inclusion criteria
The eligibility inclusion criteria included patient scheduled for surgery for localised rectal cancer; and medical clearance to participate in an exercise programme from their general practitioner.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria is patient must not have any acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit the ability to walk 400m unassisted and partake in upper- and lower-body exercises.

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)
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 293453 0
University
Name [1] 293453 0
Edith Cowan University
Address [1] 293453 0
270, Joondalup Drive, Joondalup, WA 6027, Perth, Australia
Country [1] 293453 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] 292275 0
None
Name [1] 292275 0
Address [1] 292275 0
Country [1] 292275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294900 0
Edith Cowan University Ethics Committee
Ethics committee address [1] 294900 0
270, Joondalup Drive, Joondalup, WA6027
Ethics committee country [1] 294900 0
Australia
Date submitted for ethics approval [1] 294900 0
01/09/2010
Approval date [1] 294900 0
08/11/2010
Ethics approval number [1] 294900 0
4401

Summary
Brief summary
The primary objective was to determine the benefits of a pre-surgical exercise programme for rectal cancer patients scheduled for rectal resection. It was hypothesised that: i) between baseline and pre-surgery patients would demonstrate – higher physical functional performance, maintain higher levels of muscle strength and endurance, ii) during the weeks following surgery patients would demonstrate – reduced physical functional performance, reduced muscular strength and endurance iii) between baseline and post-surgery, patients would demonstrate – improved recovery with a higher physical functional performance, maintain higher muscular strength and endurance.
Trial website
Trial related presentations / publications
Singh, F., et al. (2017). "Feasibility and Efficacy of Presurgical Exercise in Survivors of Rectal Cancer Scheduled to Receive Curative Resection." Clin Colorectal Cancer 16(4): 358-365.
Public notes

Contacts
Principal investigator
Name 65386 0
Dr Favil Singh
Address 65386 0
School of Medical and Health Sciences, Edith Cowan University, 270, Joondalup Dr, Joondalup, WA 6027
Country 65386 0
Australia
Phone 65386 0
+61863042369
Fax 65386 0
Email 65386 0
f.singh@ecu.edu.au
Contact person for public queries
Name 65387 0
Dr Favil Singh
Address 65387 0
School of Medical and Health Sciences, Edith Cowan University, 270, Joondalup Dr, Joondalup, WA 6027
Country 65387 0
Australia
Phone 65387 0
+61863042369
Fax 65387 0
Email 65387 0
f.singh@ecu.edu.au
Contact person for scientific queries
Name 65388 0
Dr Favil Singh
Address 65388 0
School of Medical and Health Sciences, Edith Cowan University, 270, Joondalup Dr, Joondalup, WA 6027
Country 65388 0
Australia
Phone 65388 0
+61863042369
Fax 65388 0
Email 65388 0
f.singh@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary