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Trial registered on ANZCTR


Registration number
ACTRN12616000021471
Ethics application status
Approved
Date submitted
1/01/2016
Date registered
14/01/2016
Date last updated
9/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehabilitation of Frail Patients undergoing Elective Colorectal Surgery – a feasibility pilot study
Scientific title
Exercise and dietary advice prehabilitation of Frail Patients undergoing Elective Colorectal Surgery – a feasibility pilot study.
Secondary ID [1] 288203 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 297115 0
Colorectal surgery 299936 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297351 297351 0 0
Other physical medicine / rehabilitation
Cancer 297455 297455 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 299835 299835 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preoperative tailored regimen of exercise with dietary advice.

Exercise will involve up to 12 sessions (maximum of three, 1-hour, small group sessions per week for 4 weeks supervised by an accredited exercise physiologist) of combined strength/cardiovascular/balance exercise in the 4 weeks prior to surgery.

Each exercise session will consist of:
- 5 mins warm-up (treadmill/mobility)
- 30 mins of circuit based combined strength/cardiovascular & balance exercises as follows = 2 sets of 8-12 reps per exercise (50% of predicted 1RM) of chest press, seated row, bicep curl, triceps extension, squat, & leg curl; AND 3-4 sets (1 min per round) of single leg balance (eyes open/closed)
- 20 mins of aerobic interval exercise (walking) based of high and low intensity at a ratio of 1:1 (1 min of higher intensity exercise [e.g. 50% heart rate reserve] interspersed with 1 min of lower intensity [e.g. 25% heart rate reserve]
- 5 mins cool down (treadmill/mobility)

Generic dietary advice will involve a single 1-hour, one-on-one educational session with a allied health professional.

All participants will maintain a diary of all exercise activities during the study.
Intervention code [1] 293585 0
Prevention
Intervention code [2] 293586 0
Treatment: Other
Comparator / control treatment
Usual care of regular medical review and medications in the 4 weeks prior to surgery.
Control group
Active

Outcomes
Primary outcome [1] 296908 0
Aerobic capacity or exercise tolerance, assessed by 6 minute walk distance (6MWD)
Timepoint [1] 296908 0
Baseline, pre-operation and ~30 days follow-up.
Secondary outcome [1] 319674 0
Quality of life via EQ5D & Short Form-12.
Timepoint [1] 319674 0
Baseline, pre-operation and ~30 days follow-up.
Secondary outcome [2] 319675 0
Physical activity levels (sitting, standing, walking time by accelerometry)
Timepoint [2] 319675 0
Baseline, pre-operation and ~30 days follow-up.
Secondary outcome [3] 319677 0
Lower body function assessed by Short Physical Performance Battery
Timepoint [3] 319677 0
Baseline, pre-operation and ~30 days follow-up
Secondary outcome [4] 319678 0
Incidence of and type of adverse events assessed by patient diary and review of hospital records
Timepoint [4] 319678 0
Baseline, pre-operation and ~30 days follow-up
Secondary outcome [5] 319851 0
Hospital length of stay assessed by review of hospital records
Timepoint [5] 319851 0
Baseline, pre-operation and ~30 days follow-up
Secondary outcome [6] 319852 0
Re-admissions to hospital assessed by review of hospital records
Timepoint [6] 319852 0
Baseline, pre-operation and ~30 days follow-up
Secondary outcome [7] 319853 0
Number of Postoperative Complications (via Dindo Clavien Classification) assessed by review of hospital records
Timepoint [7] 319853 0
Baseline, pre-operation and ~30 days follow-up
Secondary outcome [8] 319854 0
Care dependence (via modified Barthel Index) & need for rehabilitation assessed by review of hospital records
Timepoint [8] 319854 0
Baseline, pre-operation and ~30 days follow-up

Eligibility
Key inclusion criteria
Patients undergoing all major colorectal surgery (both cancer and non cancer)
Frail or Prefrail by Edmonton Frail Scale (>3 criteria)
Residents capable of attending training & assessments.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergent or Urgent Surgery (<30 days wait)

Contraindications to Prehabilitation such as:
- Unstable Angina
- Resting Systolic BP>200 or Diastolic BP>110
- Orthostatic BP drop >20mmHg
- Critical aortic stenosis (Peak systolic pressure gradient >50mmHg with an aortic valve orifice area <0.75cm2 in average adult)
- Acute systemic illness or fever
- Uncontrolled Atrial or Ventricular arrhythmias
- Uncontrolled Sinus tachycardia
- Uncompensated congestive heart failure
- 3rd Degree AV Block (without pacemaker)
- Active Pericarditis or Myocarditis
- Recent Thromboembolism
- Uncontrolled Diabetes (Resting BSL >22mmol)
- Other metabolic conditions e.g. acute thyroiditis

Severe Orthopaedic conditions prohibiting exercise
Inability to speak English or has documented learning impairment

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences between the groups at each time point examined by an independent t test. Missing data will be identified and handled on an “intention-to-treat” basis as follows: estimated based on group data at each time point or by using prior assessment values at subsequent time-points.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
26/04/2016
Actual
29/06/2017
Date of last participant enrolment
Anticipated
Actual
28/09/2017
Date of last data collection
Anticipated
Actual
13/11/2017
Sample size
Target
50
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4988 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 12474 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 292597 0
Hospital
Name [1] 292597 0
Research Trust Fund Grant, Townsville Hospital and Health Services
Country [1] 292597 0
Australia
Primary sponsor type
Individual
Name
Dr Siva Senthuran
Address
Intensive Care Unit
The Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 291316 0
Individual
Name [1] 291316 0
Associate Professor Anthony Leicht
Address [1] 291316 0
College of Healthcare Sciences
James Cook University
1 James Cook Drive
Townsville QLD 4811
Country [1] 291316 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294079 0
Townsville Hospital and Health Service Human Research Ethics Committee (EC00183)
Ethics committee address [1] 294079 0
Townsville Hospital and Health Service
Human Research Ethics Committee
Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Ethics committee country [1] 294079 0
Australia
Date submitted for ethics approval [1] 294079 0
16/09/2015
Approval date [1] 294079 0
28/10/2015
Ethics approval number [1] 294079 0
HREC/15/QTHS/176

Summary
Brief summary
The primary purpose of this feasibility pilot study is to examine the efficacy of an exercise regime and dietary advice prior to colorectal surgery in frail older adults.

Who is it for?
You may be eligible to participate in this study if you are aged 50 years or older, are considered frail, and are scheduled to undergo major colorectal surgery. You will also need to be willing and able to attend exercise and dietary advice sessions in the Townsville area.

Study details
Participants in this study will be randomly allocated (by chance) to receive either usual care prior to their surgery, or to receive a tailored exercise regime from exercise physiologists. Regimes will be tailored to each individual's level of fitness and health, but will all include elements of strength, aerobic and balance training to be carried out during a maximum of three, 1-hour sessions per week for 4 weeks.

It is hoped that the findings of this pilot study will inform researchers primarily as to whether the exercise and dietary advice intervention is feasible and effective in this patient group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61950 0
Dr Siva Senthuran
Address 61950 0
Dept of Intensive Care
Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 61950 0
Australia
Phone 61950 0
+61 431 152 521
Fax 61950 0
Email 61950 0
siva@senthuran.net
Contact person for public queries
Name 61951 0
Dr Siva Senthuran
Address 61951 0
Dept of Intensive Care
Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 61951 0
Australia
Phone 61951 0
+61 431 152 521
Fax 61951 0
Email 61951 0
siva@senthuran.net
Contact person for scientific queries
Name 61952 0
Dr Siva Senthuran
Address 61952 0
Dept of Intensive Care
Townsville Hospital
100 Angus Smith Drive
Douglas QLD 4814
Country 61952 0
Australia
Phone 61952 0
+61 431 152 521
Fax 61952 0
Email 61952 0
siva@senthuran.net

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.