Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001036606
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
25/09/2023
Date last updated
25/09/2023
Date data sharing statement initially provided
25/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Multidisciplinary prehabilitation in older persons undergoing cardiac surgery: a pilot study
Scientific title
Feasibility of multidisciplinary prehabilitation in older persons undergoing cardiac surgery: a pilot study
Secondary ID [1] 310496 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac surgery 331287 0
elderly 331288 0
frail 331289 0
Condition category
Condition code
Cardiovascular 328044 328044 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 328045 328045 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Geriatricians will review: comorbid conditions and optimisation of management in advance of surgery; review of medications and plan for management in the perioperative period; goals and limits of care and advance care plans; assessment of cognition and plan to minimise risk of delirium in the perioperative period; anticipating change in function and associated care needs at home in advance of the surgical procedure; discharge planning in advance of the procedure; and Comprehensive Geriatric Assessment.
Duration of the review: 45min to 1 hour
Frequency: one consultation and follow-up as determined by the geriatrician
Geriatric consultation will take place prior to patients' surgery

Physiotherapist will provide home exercises. The first exercise session will be conducted by the study physiotherapist at Liverpool hospital. The first exercise session will be approximately 40-60minutes in duration depending on participants. The study physiotherapist will conduct telehealth twice per week for 3 weeks (for a total of 2 telehealth sessions per week) to monitor participant’s progress in exercise program and adjust the intensity of the training according to participant’s reported perceived exertion (RPE) and symptoms if need.
All participants will be provided with exercise diary which includes images of exercises to be conducted, log of completion of exercises (day and specific exercises) and breathing exercises

An example of exercise prescription:
5-10 minutes of warm up and cool down
Aerobic training (mainly walking, steps and cycle)
Frequency: 3 times per week, 30 minutes per session
Resistance training: light to moderate 10-15 repetitions involving 6-8 groups of skeletal muscles, at least twice a week, using resistance bands
Intervention code [1] 326885 0
Treatment: Other
Intervention code [2] 326886 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335917 0
Primary outcome is proportion of participants who complete the program.
Proportion of participants who complete the program prior to the surgery assessed by patient interview, exercise diary and during telehealth.
Timepoint [1] 335917 0
Upon conclusion of the study intervention
Primary outcome [2] 336018 0

Adverse events
We do not anticipate any serious adverse event with any exercise program. Participants are provided with home exercise diary and report any problems, such as pain or discomfort so that appropriate advice and necessary change in exercise training can be made. staff will check whether the training sessions lead to any symptoms, injuries of any adverse events during telehealth.
Timepoint [2] 336018 0
Upon completion of study intervention
Secondary outcome [1] 426138 0
Participants’ adherence to intervention

Assessed via exercise diary and telehealth
Timepoint [1] 426138 0
Adherence will be assessed via telehealth and also at completion of 3-week program
Secondary outcome [2] 426493 0
Participants' and their carers' satisfaction, acceptability

via participants' and their carers' questionnaire (study-specific).
Quesionnaire will be administered by the research staff
Duration- Less than 10-15 minutes
Interview will not be audio recorded
Timepoint [2] 426493 0
on the day of discharge
Secondary outcome [3] 426494 0
Participants' evaluation of study intervention

Participant focus survey conducted by research staff
Duration: 10-15 minutes
Interview may be audio-recorded if participant consents
Timepoint [3] 426494 0
30-day post discharge
Secondary outcome [4] 426794 0
Tertiary outcome: Timed-up-and-Go (TUG) test
Timepoint [4] 426794 0
Measured at pre-intervention, post intervention (within 1 week prior to the planned surgery), day of discharge and at 30 day post discharge
Secondary outcome [5] 426795 0
Tertiary outcome: change in 6 minute walk test (6MWT)
Timepoint [5] 426795 0
6MWT test measured at pre-intervention, post intervention (within 1 week prior to the planned surgery), day of discharge and at 30 day post discharge
Secondary outcome [6] 426796 0
Tertiary outcome: Participants' independence in sit to stand without any assistance at postoperative day 4
Timepoint [6] 426796 0
Participants' independence in sit to stand without any assistance at postoperative day 4
Secondary outcome [7] 426797 0
Tertiary outcome:- Participants’ ability to walk 80 meters independently at (postoperative day 4) POD4
Timepoint [7] 426797 0
Ability of participants to walk 80 meters independently at POD4
Secondary outcome [8] 426798 0
Tertiary outcome: Hospital length of stay from patient medical records
Timepoint [8] 426798 0
Length of stay in the hospital will be noted on the day of discharge
Secondary outcome [9] 426799 0
Intensive Care Unit length of stay from patient medical records
Timepoint [9] 426799 0
Number of days stay in ICU will be noted on the day of discharge
Secondary outcome [10] 426800 0
Tertiary outcome:- Proportion of participants developing defined post operative complications (PPC) and mortality. e.g. Stroke, New cardiac arrhythmia, Deep sternal wound infection (DSWI), Re-operation for bleeding or tamponade, Derived new renal insufficiency (DNRI), Postoperative Pulmonary complications (PPCs): atelectasis; lobar consolidation; lobar collapse; or pleural effusion, Delirium, and Death.
Diagnosis of PPCs will be determined by the attending intensive care specialist and or by the radiologist aided by the use of radiography (chest X-ray (CXR), computer tomography (CT)) and other investigation as appropriate.
Timepoint [10] 426800 0
Data will be collected at day of discharge
Secondary outcome [11] 426801 0
Tertiary outcome: Discharge destination and community support e.g. return to community (with or without community services) versus need for new residential placement or transfer to rehabilitation unit
The outcome will be obtained from patient medical records
Timepoint [11] 426801 0
Data will be collected on the day of discharge
Secondary outcome [12] 426802 0
Tertiary outcome:- 30 day-mortality and readmission to the hospital
The outcome will be obtained from patient medical records
Timepoint [12] 426802 0
Data will be collected at 30 day post discharge follow up
Secondary outcome [13] 426803 0
Tertiary outcome:- Number of falls during hospital stay, 30-day post discharge as reported by patient or carer and/or documented in healthcare notes.
Timepoint [13] 426803 0
Data will be collected on the day of discharge and on the 30-day post discharge
Secondary outcome [14] 426804 0
Tertiary outcome- Quality of life survey
Timepoint [14] 426804 0
- Quality of life survey at preoperatively and at 30-day post discharge (EQ5D3L)
Secondary outcome [15] 426805 0
Tertiary outcome:- Change in Edmonton frail score
Timepoint [15] 426805 0
Change in Edmonton frail score. The outcome will be measured at pre-intervention, post intervention (within 1 week prior to the planned surgery) and at 30 day post discharge
Secondary outcome [16] 426900 0
Tertiary outcome: change in clinical frailty score
Timepoint [16] 426900 0
Change in clinical frailty score. The outcome will be measured at pre-intervention, post intervention (within 1 week prior to the planned surgery) and at 30 day post discharge

Eligibility
Key inclusion criteria
Age: 65 years and older

Clinical Frailty Score (CFS) 3-7 as assessed by Cardiothoracic surgery clinical nurse specialist (CNC), cardiologist, cardiothoracic surgeon or study personnel, at the time of agreeing to surgery at the surgeons’ rooms (including private rooms) or heart team meeting or at preadmission clinic.

Elective cardiac interventions include: elective coronary artery bypass graft surgery (CABG); aortic valve repair/replacement; mitral valve repair/replacement or combined coronary artery bypass/valve procedure, Bentall’s and transcatheter aortic valve implantation (TAVI).
Participants with an estimated 2 or more weeks of surgical waiting list time.
Ability to provide informed consent for participation and able to communicate in English.
A family member is encouraged to be present for any participant who is performing aerobic training at home.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with unstable or recently unstable cardiac syndrome/haemodynamic instability (New York Heart Association Class IV, critical left main coronary artery disease, acute coronary syndrome (ACS) before phone interview).
Participants with severe aortic or mitral stenosis whom cardiac surgeons and/or cardiologist advise not to participate in this study/exercise programs. Such participants may be referred to see a geriatrician and/or a dietitian as indicated separately to the study. Participants awaiting urgent or emergency cardiac interventions with estimated wait time of less than 2 weeks.
Participants without medical clearance and or deemed not “fit” to exercise from the surgeons or cardiologist review.

Study design
Purpose of the study
Treatment
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25471 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 41279 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 314696 0
University
Name [1] 314696 0
UNSW
Country [1] 314696 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSWSydneyNSW 2052
Country
Australia
Secondary sponsor category [1] 316669 0
Hospital
Name [1] 316669 0
Liverpool Hospital
Address [1] 316669 0
Elizabeth Street,LiverpoolNSW 2170
Country [1] 316669 0
Australia
Other collaborator category [1] 282803 0
University
Name [1] 282803 0
Western Sydney University
Address [1] 282803 0
Western Sydney UniversityNarellan Road and Gilchrist Dr,Campbelltown NSW 2560
Country [1] 282803 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313774 0
South Western Sydney Local Health Disctrict HREC
Ethics committee address [1] 313774 0
SWSLHD, Locked Bag 7279 Eastern Campus Liverpool BC NSW1871
Ethics committee country [1] 313774 0
Australia
Date submitted for ethics approval [1] 313774 0
Approval date [1] 313774 0
18/08/2023
Ethics approval number [1] 313774 0
2023/ETH01430

Summary
Brief summary
Four in five (80%) older Australians report having one or more long-term health condition. Older frail patients who undergo cardiac surgery have poorer postoperative outcomes.
There is some evidence that multidisciplinary prehabilitation may reduce the number of postoperative complications in older patients undergoing abdominal cancer surgery.
There is a need for the current pilot study to demonstrate the feasibility of the multidisciplinary prehabilitation program in frail older persons and to investigate any potential risk, adverse events, compliance to exercise program and satisfaction in this patient population who has higher likelihood of unwanted postoperative outcome after cardiac surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129106 0
Dr Serena Hong
Address 129106 0
UNSWSydney, NSW 2052
Country 129106 0
Australia
Phone 129106 0
+61 410412361
Fax 129106 0
Email 129106 0
serena.hong@unsw.edu.au
Contact person for public queries
Name 129107 0
Dr Serena Hong
Address 129107 0
UNSWSydney, NSW 2052
Country 129107 0
Australia
Phone 129107 0
+61 410412361
Fax 129107 0
Email 129107 0
serena.hong@unsw.edu.au
Contact person for scientific queries
Name 129108 0
Dr Serena Hong
Address 129108 0
UNSWSydney, NSW 2052
Country 129108 0
Australia
Phone 129108 0
+61 410412361
Fax 129108 0
Email 129108 0
serena.hong@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable participant data underlying published results
When will data be available (start and end dates)?
ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of primary sponsor
Available for what types of analyses?
to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator. PI can be contacted by email, serena.hong@unsw.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20172Study protocol  serena.hong@unsw.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.