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Trial registered on ANZCTR


Registration number
ACTRN12620000315910
Ethics application status
Approved
Date submitted
4/02/2020
Date registered
6/03/2020
Date last updated
6/03/2020
Date data sharing statement initially provided
6/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-operative high intensity interval training in patients undergoing major foregut cancer surgery: A randomised controlled trial
Scientific title
Post-operative high intensity interval training in patients undergoing major foregut cancer surgery, investigating the effect on the 6 minute walk test: A randomised controlled trial
Secondary ID [1] 296853 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
HIITcancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer 315611 0
Gastric Cancer 315612 0
Pancreatic Cancer 315613 0
Oesophageal Cancer 315614 0
Oesophago-gastric Junction Cancer 315615 0
Condition category
Condition code
Cancer 313905 313905 0 0
Liver
Cancer 313906 313906 0 0
Stomach
Cancer 313907 313907 0 0
Pancreatic
Cancer 313908 313908 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) A trained project officer will administer the sessions
b) The exercise will be administered one-on-one at the patients bed side and within the ward of the hospital
c) The level of intensity will range from moderate to hard. This is assessed using the Borg RPE 10 point scale, with the intensity aimed at 4-7. Furthermore, hear rate will also be measured.
d) Exercise session duration is between 15-45 minutes depending on each patients recovery status
e) The frequency of the intervention will be two times per day from post-operative day 1 to discharge
f) The project officer will document adherence rate and attendance rate. Attendance rate will be a binary outcome of yes and no if the session was to start. The adherence rate would be the number of exercises performed by the number of exercises prescribed each session.
f) Resistance sessions will include, chest press, knee extension, bicep curl, shoulder press, lateral raise, calf raise and sit to stands. The cardio sessions will include, arm cycling, leg cycling, walking, and step ups.
The intervention is in addition to standard care as usual.
Intervention code [1] 316363 0
Rehabilitation
Comparator / control treatment
Standard care post operative protocol involves ERAS( enhanced recovery after surgery). Protocol includes, assessment, oral intake, fluid management, NJ , Drain, IDC, physio, medication, analgesia, DVT and bowels. Currently, physio focus on sitting in chair, breathing exercise. Standard care differs from the intervention as there is no excise plan in the post operative protocol.
Control group
Active

Outcomes
Primary outcome [1] 322297 0
6 Minute Walk Test
Timepoint [1] 322297 0
The primary time point is discharge from hospital.
The follow up time points will be 1 month post hospital discharge & 3 months post hospital discharge
Primary outcome [2] 322298 0
Grip Strength Test. This test will be measured using a dynamo-meter, using the protocol of three grip strength test on each hand, and documenting the average of both the left and right hand.
Timepoint [2] 322298 0
The primary time point is discharge from hospital.
The follow up time points will be 1 month post hospital discharge & 3 months post hospital discharge
Secondary outcome [1] 377995 0
Length of Stay in Hospital. This will be measured from the hospital records from day of surgery until day of discharge, which will be obtained from the patients discharge summary.
Timepoint [1] 377995 0
Discharge from hospital
Secondary outcome [2] 377996 0
Respiratory Complications. These complications will include
Pneumonia
Pleural effusion (requiring drainage procedure)
Pneumothorax requiring treatment
Athelectasis mucous plugging requiring bronchoscopy
Respiratory failure requiring reintubation
Acute respiratory distress syndrome
Acute aspiration
Tracheobronchial injury
Chest tube maintenance for air leak (>10d post-operatively)
Hypoxia, otherwise unexplained
Mediastinitis
Rate of severity of these complications will be measured using clavien dindo classification.
For this outcome the data will be collected by data-linkage to the hospital records of the patients stay in hospital.
Timepoint [2] 377996 0
Discharge from hospital
Secondary outcome [3] 377998 0
Quality of Life will be measured using the EORTC QLQ C30. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health related
quality of life (QoL) of cancer patients participating in international clinical trials.
Timepoint [3] 377998 0
The primary time point is discharge from hospital.
The follow up time points will be 1 month post hospital discharge & 3 months post hospital discharge
Secondary outcome [4] 377999 0
Anxiety and Depression will be measured using the HADS (Hospital Anxiety and Depression scale).
Timepoint [4] 377999 0
The primary time point is discharge from hospital.
The follow up time points will be 1 month post hospital discharge & 3 months post hospital discharge

Eligibility
Key inclusion criteria
• Has either upper GI or HPB cancer as determined by attendance of Clinic at St
Vincent’s Hospital, and therefore, UNDERGOING major foregut cancer surgery
• Ability to understand and take instructions of exercises in English
• Provide a signed and dated informed consent form
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Has clinically diagnosed alternate malignancies
• Has multiple concurrent malignancies
• Severe COPD
• Prisoners
• Emergency procedures

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)
VIC
Recruitment hospital [1] 15501 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 28856 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 301425 0
Government body
Name [1] 301425 0
Western & Central Melbourne Integrated Cancer Service
Address [1] 301425 0
2 St Andrews Pl, East Melbourne, Victoria 3002
Country [1] 301425 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Melbourne
Address
41 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 304810 0
None
Name [1] 304810 0
Address [1] 304810 0
Country [1] 304810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302158 0
St Vincent's Hospital, Melbourne Research Governance Unit, Melbourne
Ethics committee address [1] 302158 0
Research Governance Unit

Level 5, Building E (Aikenhead Building)

27 Victoria Parade

Fitzroy VIC 3065
Ethics committee country [1] 302158 0
Australia
Date submitted for ethics approval [1] 302158 0
07/01/2020
Approval date [1] 302158 0
28/01/2020
Ethics approval number [1] 302158 0

Summary
Brief summary
The purpose of this study is to assess the effect of early intervention exercise after surgery on mood and post-operative outcomes.

Who is it for?

You may be eligible for this study if you are aged 18 or over, and undergoing major foregut cancer surgery.

Study details

Participants in this study will be randomised by blocking, into two groups. Participants in one group will receive standard care which includes, enhanced recovery after surgery protocol. The other group will start exercise from the first post-operative day until discharge from hospital. The exercises will involve two sessions daily, one resistance training and one cardio training. The resistance training will involve chest press, knee extension, bicep curl, shoulder press, lateral raise, calf raises and sit to stand. The cardio training will involve walking, arm cycling, leg cycling, and step ups. The sessions will last approximately 10-45 minutes. As a part of this study, all participants will answer questionnaires and undergo simple fitness tests prior to surgery, when leaving the hospital, and at 1 month and 3 months after discharge from hospital.

It is hoped this research will demonstrate starting exercise sooner will results in improved mood and physical outcomes.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89326 0
Mr Michael Hii
Address 89326 0
St Vincent's Hospital, Melbourne
41 Victoria Parade, Fitzroy VIC 3065
Country 89326 0
Australia
Phone 89326 0
+61 3 9231 2211
Fax 89326 0
Email 89326 0
Michael.Hii@svha.org.au
Contact person for public queries
Name 89327 0
Miss Alexandra Hodal
Address 89327 0
St Vincent's Hospital, Melbourne
41 Victoria Parade, Fitzroy VIC 3065
Country 89327 0
Australia
Phone 89327 0
+61 3 9231 2211
Fax 89327 0
Email 89327 0
alexandra.hodal@svha.org.au
Contact person for scientific queries
Name 89328 0
Mr Michael Hii
Address 89328 0
St Vincent's Hospital, Melbourne
41 Victoria Parade, Fitzroy VIC 3065
Country 89328 0
Australia
Phone 89328 0
+61 3 9231 2211
Fax 89328 0
Email 89328 0
Michael.Hii@svha.org.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?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6303 0
Ethical approval
Citation [1] 6303 0
Link [1] 6303 0
Email [1] 6303 0
alexandra.hodal@svha.org.au
Other [1] 6303 0
Attachment [1] 6303 0
Summary results
No Results