Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Feasibility of multidisciplinary prehabilitation in older persons undergoing cardiac surgery: a pilot study
Query!
Secondary ID [1]
310496
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
cardiac surgery
331287
0
Query!
elderly
331288
0
Query!
frail
331289
0
Query!
Condition category
Condition code
Cardiovascular
328044
328044
0
0
Query!
Coronary heart disease
Query!
Physical Medicine / Rehabilitation
328045
328045
0
0
Query!
Physiotherapy
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
326885
0
Treatment: Other
Query!
Intervention code [2]
326886
0
Lifestyle
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
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.
Query!
Assessment method [1]
335917
0
Query!
Timepoint [1]
335917
0
Upon conclusion of the study intervention
Query!
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.
Query!
Assessment method [2]
336018
0
Query!
Timepoint [2]
336018
0
Upon completion of study intervention
Query!
Secondary outcome [1]
426138
0
Participants’ adherence to intervention
Assessed via exercise diary and telehealth
Query!
Assessment method [1]
426138
0
Query!
Timepoint [1]
426138
0
Adherence will be assessed via telehealth and also at completion of 3-week program
Query!
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
Query!
Assessment method [2]
426493
0
Query!
Timepoint [2]
426493
0
on the day of discharge
Query!
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
Query!
Assessment method [3]
426494
0
Query!
Timepoint [3]
426494
0
30-day post discharge
Query!
Secondary outcome [4]
426794
0
Tertiary outcome: Timed-up-and-Go (TUG) test
Query!
Assessment method [4]
426794
0
Query!
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
Query!
Secondary outcome [5]
426795
0
Tertiary outcome: change in 6 minute walk test (6MWT)
Query!
Assessment method [5]
426795
0
Query!
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
Query!
Secondary outcome [6]
426796
0
Tertiary outcome: Participants' independence in sit to stand without any assistance at postoperative day 4
Query!
Assessment method [6]
426796
0
Query!
Timepoint [6]
426796
0
Participants' independence in sit to stand without any assistance at postoperative day 4
Query!
Secondary outcome [7]
426797
0
Tertiary outcome:- Participants’ ability to walk 80 meters independently at (postoperative day 4) POD4
Query!
Assessment method [7]
426797
0
Query!
Timepoint [7]
426797
0
Ability of participants to walk 80 meters independently at POD4
Query!
Secondary outcome [8]
426798
0
Tertiary outcome: Hospital length of stay from patient medical records
Query!
Assessment method [8]
426798
0
Query!
Timepoint [8]
426798
0
Length of stay in the hospital will be noted on the day of discharge
Query!
Secondary outcome [9]
426799
0
Intensive Care Unit length of stay from patient medical records
Query!
Assessment method [9]
426799
0
Query!
Timepoint [9]
426799
0
Number of days stay in ICU will be noted on the day of discharge
Query!
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.
Query!
Assessment method [10]
426800
0
Query!
Timepoint [10]
426800
0
Data will be collected at day of discharge
Query!
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
Query!
Assessment method [11]
426801
0
Query!
Timepoint [11]
426801
0
Data will be collected on the day of discharge
Query!
Secondary outcome [12]
426802
0
Tertiary outcome:- 30 day-mortality and readmission to the hospital
The outcome will be obtained from patient medical records
Query!
Assessment method [12]
426802
0
Query!
Timepoint [12]
426802
0
Data will be collected at 30 day post discharge follow up
Query!
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.
Query!
Assessment method [13]
426803
0
Query!
Timepoint [13]
426803
0
Data will be collected on the day of discharge and on the 30-day post discharge
Query!
Secondary outcome [14]
426804
0
Tertiary outcome- Quality of life survey
Query!
Assessment method [14]
426804
0
Query!
Timepoint [14]
426804
0
- Quality of life survey at preoperatively and at 30-day post discharge (EQ5D3L)
Query!
Secondary outcome [15]
426805
0
Tertiary outcome:- Change in Edmonton frail score
Query!
Assessment method [15]
426805
0
Query!
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
Query!
Secondary outcome [16]
426900
0
Tertiary outcome: change in clinical frailty score
Query!
Assessment method [16]
426900
0
Query!
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
Query!
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.
Query!
Minimum age
65
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/02/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/10/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
12
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
25471
0
Liverpool Hospital - Liverpool
Query!
Recruitment postcode(s) [1]
41279
0
2170 - Liverpool
Query!
Funding & Sponsors
Funding source category [1]
314696
0
University
Query!
Name [1]
314696
0
UNSW
Query!
Address [1]
314696
0
UNSW SydneyNSW 2052
Query!
Country [1]
314696
0
Australia
Query!
Primary sponsor type
University
Query!
Name
UNSW
Query!
Address
UNSWSydneyNSW 2052
Query!
Country
Australia
Query!
Secondary sponsor category [1]
316669
0
Hospital
Query!
Name [1]
316669
0
Liverpool Hospital
Query!
Address [1]
316669
0
Elizabeth Street,LiverpoolNSW 2170
Query!
Country [1]
316669
0
Australia
Query!
Other collaborator category [1]
282803
0
University
Query!
Name [1]
282803
0
Western Sydney University
Query!
Address [1]
282803
0
Western Sydney UniversityNarellan Road and Gilchrist Dr,Campbelltown NSW 2560
Query!
Country [1]
282803
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
313774
0
South Western Sydney Local Health Disctrict HREC
Query!
Ethics committee address [1]
313774
0
SWSLHD, Locked Bag 7279 Eastern Campus Liverpool BC NSW1871
Query!
Ethics committee country [1]
313774
0
Australia
Query!
Date submitted for ethics approval [1]
313774
0
Query!
Approval date [1]
313774
0
18/08/2023
Query!
Ethics approval number [1]
313774
0
2023/ETH01430
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
129106
0
Dr Serena Hong
Query!
Address
129106
0
UNSWSydney, NSW 2052
Query!
Country
129106
0
Australia
Query!
Phone
129106
0
+61 410412361
Query!
Fax
129106
0
Query!
Email
129106
0
[email protected]
Query!
Contact person for public queries
Name
129107
0
Dr Serena Hong
Query!
Address
129107
0
UNSWSydney, NSW 2052
Query!
Country
129107
0
Australia
Query!
Phone
129107
0
+61 410412361
Query!
Fax
129107
0
Query!
Email
129107
0
[email protected]
Query!
Contact person for scientific queries
Name
129108
0
Dr Serena Hong
Query!
Address
129108
0
UNSWSydney, NSW 2052
Query!
Country
129108
0
Australia
Query!
Phone
129108
0
+61 410412361
Query!
Fax
129108
0
Query!
Email
129108
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Non-identifiable participant data underlying published results
Query!
When will data be available (start and end dates)?
ending 5 years following main results publication
Query!
Available to whom?
case-by-case basis at the discretion of primary sponsor
Query!
Available for what types of analyses?
to achieve the aims in the approved proposal
Query!
How or where can data be obtained?
access subject to approvals by Principal Investigator. PI can be contacted by email,
[email protected]
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20172
Study protocol
[email protected]
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.
Download to PDF