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Trial registered on ANZCTR


Registration number
ACTRN12617001129370
Ethics application status
Approved
Date submitted
28/07/2017
Date registered
1/08/2017
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of pre-operative exercise to improve patient outcomes after major pelvic cancer surgery: A pilot randomised controlled trial.
Scientific title
Feasibility and acceptability of pre-operative exercise to improve patient outcomes after major pelvic cancer surgery: A pilot randomised controlled trial.
Secondary ID [1] 292553 0
none
Universal Trial Number (UTN)
U1111-1199-9749
Trial acronym
PEPA Trial
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Pelvic Cancer 304208 0
Condition category
Condition code
Cancer 303547 303547 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 303548 303548 0 0
Ovarian and primary peritoneal
Cancer 308772 308772 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative exercise programme:
The exercise programme will consist of 60 minutes individualised (one-to-one) training session with a registered physiotherapist, once a week, for 2 to 6 weeks (maximal of 6 sessions) before the patient undergoes their scheduled surgery. The last day of exercise will be the day before the patient undergoes surgery. The duration (2-6 weeks), specific exercises performed and intensity of the exercise programme will all be tailored to each patient through a health assessment, taking into consideration their current health status, physical activity level, co-morbidities and medical history. Each session will consist of 10 minutes of warm-up (walking and cycling), 40 minutes of aerobic and endurance exercises (such as cycling, treadmill and rower activity), respiratory and muscle strength exercises (breathing and weights training), and 10 minutes cool down (stretches and flexibility exercises). The aerobic and endurance exercises will be performed at 40% to 60% of the maximum heart rate and the strength training will be performed at an intensity of 40% to 60% of the one repetition maximum. Participant will be given instruction and recommendations on how to complete and progress these exercises (or similar exercises) at home (4 sessions x 60 minutes at home per week, up to the scheduled date of surgery). Furthermore, apart from the prescribed exercises, participants will be recommended to engage in moderate-intensity exercise for at least 150 minutes per week (such as walking or cycling). Home exercises will be captured in a daily exercise diary that participants will complete until the end of the exercise programme.
Intervention code [1] 298750 0
Lifestyle
Intervention code [2] 298766 0
Treatment: Other
Comparator / control treatment
Usual care:
The usual care group (no formal exercise training) will receive the routine care throughout their cancer pathway, from diagnosis to surgical resection. No specific advice about exercise training will be offered.
Control group
Active

Outcomes
Primary outcome [1] 302918 0
The feasibility of incorporating a standardised, intensive exercise programme into the pre-operative period for patients undergoing pelvic exenteration at Royal Prince Alfred Hospital.
This will be determined by the number of eligible patients recruited, retention and adherence rates to the exercise programme. The retention rate will be defined as the percentage of individuals who completed the intervention. Adherence will be defined as the percentage of exercise sessions attended by those who were randomised to the intervention group. Adherence to the exercise programme will be recorded using attendance records (recorded by the study physiotherapist) / participant exercise diaries (recorded by the participant).
Timepoint [1] 302918 0
Feasibility will be assessed during the week before surgery (1 week pre-operative),
Primary outcome [2] 302919 0
The acceptability of incorporating a standardised, intensive exercise programme into the pre-operative period for patients undergoing pelvic exenteration at Royal Prince Alfred Hospital. This will be assessed by a semi structured questionnaire pre-discharge.
Timepoint [2] 302919 0
Acceptability will be assessed shortly before discharge after surgery (pre-hospital discharge).
Primary outcome [3] 302934 0
The acceptability to patients of being randomised to the exercise program or usual care (satisfaction with study intervention). This will be determined by the number or eligible patients recruited to the trial (who accept being randomised to either treatment group), and by a semi structured questionnaire pre-discharge.
Timepoint [3] 302934 0
Acceptability of randomisation and patient satisfaction with the study intervention will be assessed at enrollment to the study and at pre-hospital discharge.
Secondary outcome [1] 337443 0
Pilot data on the likely difference in post-operative complications to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by perioperative and inpatient data from patient medical records.
Timepoint [1] 337443 0
Post-operative complications will be assessed at 10-days post-operative.
Secondary outcome [2] 337483 0
Pilot data on the likely difference in length of hospital stay to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed using admission data from patient medical records.
Timepoint [2] 337483 0
Length of hospital stay will be assessed at time of patient discharge from hospital.
Secondary outcome [3] 337484 0
Pilot data on the likely difference in quality of life to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by the SF-36 (V2) questionnaire.
Timepoint [3] 337484 0
Quality of life will be assessed at baseline (pre-operative), during the week before surgery (1 week pre-operative), 10 days post-operative and pre hospital discharge.
Secondary outcome [4] 337485 0
Pilot data on the likely difference in post-operative functional capacity to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by the 6-minute walking-test.
Timepoint [4] 337485 0
Post-operative functional capacity will be assessed at baseline (pre-operative), during the week before surgery (1 week pre-operative), 10 days post-operative and pre hospital discharge.
Secondary outcome [5] 337488 0
Pilot data on the likely difference in quadriceps strength to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by the quadriceps strength test and the five times sit to stand test.
Timepoint [5] 337488 0
Quadriceps strength will be assessed at baseline (pre-operative), during the week before surgery (1 week pre-operative), 10 days post-operative and pre hospital discharge.
Secondary outcome [6] 337489 0
Pilot data on the likely difference in physical activity to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by the the IPAQ-SF questionnaire.
Timepoint [6] 337489 0
Physical activity will be assessed at baseline (pre-operative), during the week before surgery (1 week pre-operative), 10 days post-operative and pre hospital discharge.
Secondary outcome [7] 337490 0
Pilot data on the likely difference in exercise self-efficacy to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by the exercise self-efficacy scale.
Timepoint [7] 337490 0
Exercise self-efficacy will be assessed at baseline.
Secondary outcome [8] 337491 0
Pilot data on the likely difference in patient depression, anxiety and stress to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by the Depression, Anxiety, Stress scale.
Timepoint [8] 337491 0
Depression, Anxiety, Stress will be assessed at baseline.
Secondary outcome [9] 337492 0
Pilot data on the likely difference in patient pain level to inform the sample size calculation for a future substantive randomised clinical trial.
This will be assessed by the Numerical pain rating scale.
Timepoint [9] 337492 0
Pain level will be assessed at baseline (pre-operative), during the week before surgery (1 week pre-operative), 10 days post-operative and pre hospital discharge.

Eligibility
Key inclusion criteria
To be eligible for the study, patients will be adults aged 18-80 years ::
(a) Undergoing elective major advanced or recurrent gastrointestinal cancer surgery;
(b) Present at a gastrointestinal surgeon at least 2 weeks prior to planned surgery.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they have:
(a) Cognitive impairment such that they are unable to give informed consent;
(b) Co-morbidity preventing participation in exercise (i.e. major cardiac, respiratory or musculoskeletal disease);
(c) Inadequate English to complete outcome measures or understand verbal instructions;
(d) Current participation in an exercise programme similar to the proposed intervention.
(e) Unable to attend exercise program (e.g. living in other state).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
A research officer not involved in the trial will prepare the group allocation after written informed consent and baseline assessment are obtained. Randomisation will be carried out on a 1:1 basis and will utilise a computer-based random sequence generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be stratified by surgical procedure (cytoreductive surgery or pelvic exenteration) and randomised on a 1:1 basis by a computer-based random sequence generator. Variable-sized blocks will be used to ensure approximately equal numbers in the two trial arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be stored in a REDCap database and statistical analysis will be performed using IBM SPSS Statistics version 22 (SPSS Inc., Chicago, IL, USA).
The proportion of patients who consent to the study and reasons for non-consent will be summarised. Characteristics of patients randomised to each group will be compared. The number and percentage of intervention group participants who commenced, completed each component and completed the full exercise programme will be calculated. The proportion of patients who developed major complications and the median length of stay will be compared between intervention and control groups. For the four secondary outcomes (functional capacity, physical activity, quadriceps strength and quality of life) change in scores between baseline, 1-week pre-operatively and 12-weeks post-operatively will be compared between intervention and control groups to inform future sample size calculations. The overall score of the semi-structured questionnaire will reveal the acceptability of the exercise programme.

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)
NSW
Recruitment hospital [1] 8657 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 16765 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 297127 0
Other Collaborative groups
Name [1] 297127 0
Sydney Catalyst
Address [1] 297127 0
Chris O'Brien Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown
NSW
2050
Country [1] 297127 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11, KGV Building
Missenden Road
Camperdown
NSW
2050
Country
Australia
Secondary sponsor category [1] 296145 0
None
Name [1] 296145 0
Address [1] 296145 0
Country [1] 296145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298301 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 298301 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown
NSW
2050
Ethics committee country [1] 298301 0
Australia
Date submitted for ethics approval [1] 298301 0
31/05/2017
Approval date [1] 298301 0
13/07/2017
Ethics approval number [1] 298301 0
HREC/17/RPAH/282 and X17-0189

Summary
Brief summary
The primary purpose of this trial is to evaluate the feasibility and acceptability of a pre-operative exercise program in people undergoing major pelvic cancer surgery.

Who is it for?
You may be eligible to enrol in this trial if you are aged 18-80 years and are scheduled to undergo major pelvic cancer surgery.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either the exercise program or to receive usual care. Participants allocated to the exercise program will receive a supervised one hour one-on-one exercise session once per week for 2-6 weeks, occurring prior to surgery. They will also be asked to complete the hour-long exercise session at home four days per week in addition to 150 minutes of moderate exercise (walking, cycling, etc.) per week. Following surgery, participants will be asked for their opinion of the exercise program, and some additional tests and questionnaires will also be completed to assess physical activity, strength, complications and other outcomes following surgery.

It is hoped that the findings from this trial will provide information on whether the pre-operative exercise program is feasible and acceptable to participants, as well as providing preliminary data on the efficacy of the program for improving health outcomes following major pelvic cancer surgery.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 76642 0
Dr Daniel Steffens
Address 76642 0
Surgical Outcomes Research Centre (SOuRCe)
Building 89, Level 9
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW
2050
Country 76642 0
Australia
Phone 76642 0
+61 2 9515 3203
Fax 76642 0
+61 2 9515 3222
Email 76642 0
Daniel.Steffens@sswahs.nsw.gov.au
Contact person for public queries
Name 76643 0
Dr Daniel Steffens
Address 76643 0
Surgical Outcomes Research Centre (SOuRCe)
Building 89, Level 9
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW
2050
Country 76643 0
Australia
Phone 76643 0
+61 2 9515 3203
Fax 76643 0
+61 2 9515 3222
Email 76643 0
Daniel.Steffens@sswahs.nsw.gov.au
Contact person for scientific queries
Name 76644 0
Dr Daniel Steffens
Address 76644 0
Surgical Outcomes Research Centre (SOuRCe)
Building 89, Level 9
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW
2050
Country 76644 0
Australia
Phone 76644 0
+61 2 9515 3203
Fax 76644 0
+61 2 9515 3222
Email 76644 0
Daniel.Steffens@sswahs.nsw.gov.au

No data has been provided for results reporting
Summary results
Not applicable