Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001286134p
Ethics application status
Submitted, not yet approved
Date submitted
27/08/2019
Date registered
18/09/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Strength Training Enhances Recovery After Surgery: The STERAS Project
Scientific title
In surgery patients, does an individualised perioperative exercise program with targeted education, improve patient recovery time and outcomes, compared to usual practice?
Secondary ID [1] 299126 0
nil known
Universal Trial Number (UTN)
U1111-1239-3248
Trial acronym
STERAS
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer 314196 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312552 312552 0 0
Other physical medicine / rehabilitation
Cancer 312674 312674 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 3 arm randomised controlled intervention trial will be conducted. ENT surgery patients will be randomised to either to 1) prehabilitation (pre-surgery) group, 2) prehabilitation (pre-surgery) + rehabilitation (post-surgery) group or 3) usual care group. A similar study, currently ongoing in general surgery patients has informed the logistics of recruitment and demonstrated the feasibility of pre- and post-operative measures as proposed below, including bio impedance analysis, isometric grip strength and QoL measures not routinely used in practice currently. This study design has been informed by Enhanced Recovery After Surgery (ERAS) best practice principles.
The prehabilitation group (n=20) will involve an individualised exercise program (aerobic/resistance training + walking program), standardised education and engagement based on an in-person meeting at their first appointment at FSH. Patients will be invited to attend FSH or MU three times a week to undertake small group (<10 patients) gym-based resistance-focused exercises tailored to the patient, integrating a number of fitness activities with strength and functional training. Patients will complete 20 minutes of aerobic training (60-85% age predicted HR max) at the commencement of each gym based training session. The aerobic training will consist of various modes of exercise including treadmill, cycling and rowing ergometers. The strength training exercises will involve the large muscle groups that commence at 50% maximum voluntary contractions, as assessed by isometric dynamometry (Lafayette Muscle Meter, SI Instruments, Sth Australia). The gym based sessions will be supervised by either an Exercise Physiologist or Physiotherapist and last approximately 60 minutes. Patients will be provided a home walking program and diary to log their activity duration and sessional rating of perceived exertion (sRPE). Session attendance will be collected as will details of the weights lifted for each session. Following surgery this group will revert to usual post-operative care. As per inclusion criteria participants must have a scheduled surgery with a wait time >2 weeks therefore the prehabilitation program will run for at least 2 weeks (maximum of 6 weeks).
Home based walking program: participants are encouraged to complete 150 minutes of moderate intense physical activity per week. For those in the usual care group, walking will be the selected mode of exercise. For the intervention groups participants will be asked to walk for 30mins on the days they do not attend the gym based exercise sessions.
Standardised education: This takes place at the patient’s first visit and includes a one on one meeting with a senior physiotherapist who provides the patients with pamphlets on diet, exercise and lifestyle habits to achieve prior to surgery. This information/education pack is provided to all surgery patients at Fiona Stanley Hospital.
The prehabilitation + rehabilitation group (n=20) will be identical to the prehabilitation group above, with the addition of a 6 week rehabilitation program (aerobic/resistance training + walking program) post-surgery. The 6 week rehabilitation program (post-surgery) will follow the same format as the prehabilitation program. This will consist of 3x 60minute gym based sessions per week supervised by the same staff responsible for the prehabilitation program. While the rehabilitation program aims to replicate the prehabilitation exercise program (same exercises/intensity etc.), the impact of surgery on each individual patient will be taken into consideration and exercises modified as required. Intensity prescribed post-surgery will commence low with the aim of returning to pre-surgery intensities if/when suitable. Individual session attendance will be documented and home based logs (detailing any home based walking) will be collected every 2 weeks.
Intervention code [1] 315400 0
Rehabilitation
Intervention code [2] 315401 0
Treatment: Other
Comparator / control treatment
The routine care group will be provided with standardised education (as part of their Enhanced Recovery After Surgery [ERAS] program at Fiona Stanley Hospital) at recruitment as per intervention group. Patients will be provided with a diary to record physical activity levels. Port-operative care (multi-disciplinary team input as an inpatient and at hospital clinic visits) will be as clinically applicable and will be routine for both groups.
Control group
Active

Outcomes
Primary outcome [1] 321199 0
Length of stay (in hospital) post surgery. Assessed upon discharge (via hospital medical record).
Timepoint [1] 321199 0
once upon discharge from hospital
Primary outcome [2] 321200 0
readmission rate via hospital medical record
Timepoint [2] 321200 0
once at readmission to hospital (if applicable)
Secondary outcome [1] 374295 0
Intensive care unit (ICU) length of stay via hospital medical records
Timepoint [1] 374295 0
once upon discharge from hospital
Secondary outcome [2] 374296 0
Adverse events relating to surgery (e.g. wound complications, genitourinary, cardiovascular, and gastrointestinal consequences). Data extracted from hospital medical records.
Timepoint [2] 374296 0
once post surgery
Secondary outcome [3] 374297 0
Quality of recovery via the QoR 15 questionnaire
Timepoint [3] 374297 0
1 week post surgery
6 weeks post surgery
12 weeks post surgery
24 weeks post surgery
Secondary outcome [4] 374298 0
Body composition (fat mass, lean body mass and bone mineral density) will be assessed via DEXA.
Timepoint [4] 374298 0
pre surgery
1 week post surgery
6 weeks post surgery
12 weeks post surgery
24 weeks post surgery
Secondary outcome [5] 374299 0
Grip strength via isometric dynamometry
Timepoint [5] 374299 0
pre surgery
1 week post surgery
6 weeks post surgery
12 weeks post surgery
24 weeks post surgery
Secondary outcome [6] 374300 0
Lower limb functional ability assessed via Lower limb functional index (LLFI)
Timepoint [6] 374300 0
pre surgery
1 week post surgery
6 weeks post surgery
12 weeks post surgery
24 weeks post surgery
Secondary outcome [7] 374301 0
Upper limb functionality assessed via quickDASH
Timepoint [7] 374301 0
pre surgery
1 week post surgery
6 weeks post surgery
12 weeks post surgery
24 weeks post surgery
Secondary outcome [8] 374302 0
quality of life (SF36)
Timepoint [8] 374302 0
pre surgery
1 week post surgery
6 weeks post surgery
12 weeks post surgery
24 weeks post surgery

Eligibility
Key inclusion criteria
All general and head and neck cancer surgery patients at FSH with a predicted pre-operative lead time of 2 weeks or over. Patients undergoing pre-operative chemotherapy and/or radiotherapy at FSH will be recruited
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any general and head and neck cancer surgery patients at FSH that have less than 2 week predicted lead time of their surgery. Patients that are unable to travel or access FSH to attend the three sessions of gym exercises per week will also be excluded.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Frequencies, descriptive statistics, correlations, effect size estimation; and, for secondary outcomes (see sample size calculation below): linear mixed models with distributions and link functions appropriate to the outcome variables considered. Quantitative report

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14655 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 27681 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 303667 0
Government body
Name [1] 303667 0
Western Australia Cancer and Palliative Care Network
Country [1] 303667 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street Murdoch, WA, 6150
Country
Australia
Secondary sponsor category [1] 303770 0
Hospital
Name [1] 303770 0
Fiona Stanley Hospital
Address [1] 303770 0
11 Robin Warren Dr, Murdoch WA 6150
Country [1] 303770 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304188 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 304188 0
Level 2, Administration Building
Fiona Stanley Hospital
14 Barry Marshall Parade
Murdoch, 6150
Ethics committee country [1] 304188 0
Australia
Date submitted for ethics approval [1] 304188 0
19/08/2019
Approval date [1] 304188 0
Ethics approval number [1] 304188 0
Ethics committee name [2] 304191 0
Murdoch University Human Research Ethics Committee
Ethics committee address [2] 304191 0
90 South Street Murdoch, WA 6150
Ethics committee country [2] 304191 0
Australia
Date submitted for ethics approval [2] 304191 0
02/09/2019
Approval date [2] 304191 0
Ethics approval number [2] 304191 0

Summary
Brief summary
The purpose of the study is to determine if a strength-focused exercise program prior to surgery can improve participant’s physical function, reduce time in hospital and complications from surgery, and help restore physical function and quality of life post-surgery.

Who is it for?
You may be eligible for this study if you are an adult who is having surgery due to head and neck cancer at Fiona Stanley Hospital in Western Australia.

Study details
Participants in this study will receive one of three different treatments:
1. A ‘pre-habilitation’ exercise program, involving a strength and aerobic exercise program prior to surgery. Participants in this group will also receive an education program.
2. The same pre-habilitation program as group 1, plus an additional 6-week post-surgery rehabilitation program.
3. Usual care including an education program, and routine post-operative care.

Participants in this study will be randomly allocated to one of these treatment groups, and will also need to complete a battery of physical function tests including a timed up and go test, grip strength, step test and DEXA scan. You will also need to complete a number of self reported questionnaires relating to your quality of life, quality of recovery and functional ability.

It is hoped that this research will help determine if a pre-habiltiation program is effective at improving post-surgery outcomes in head and neck cancer patients.
Trial website
nil
Trial related presentations / publications
n/a
Public notes
n/a

Contacts
Principal investigator
Name 96086 0
Dr Bradley A. Wall
Address 96086 0
Murdoch University
90 South Street, Murdoch, WA 6150
Country 96086 0
Australia
Phone 96086 0
+61893606759
Fax 96086 0
Email 96086 0
b.wall@murdoch.edu.au
Contact person for public queries
Name 96087 0
Dr Bradley A. Wall
Address 96087 0
Murdoch University
90 South Street, Murdoch, WA 6150
Country 96087 0
Australia
Phone 96087 0
+61893606759
Fax 96087 0
Email 96087 0
b.wall@murdoch.edu.au
Contact person for scientific queries
Name 96088 0
Dr Bradley A. Wall
Address 96088 0
Murdoch University
90 South Street, Murdoch, WA 6150
Country 96088 0
Australia
Phone 96088 0
+61893606759
Fax 96088 0
Email 96088 0
b.wall@murdoch.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4350Study protocol  b.wall@murdoch.edu.au
4351Statistical analysis plan  b.wall@murdoch.edu.au
4352Informed consent form  b.wall@murdoch.edu.au
4353Ethical approval  b.wall@murdoch.edu.au



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.