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Trial registered on ANZCTR
Registration number
ACTRN12624001126505
Ethics application status
Approved
Date submitted
3/09/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessing the Impact Cardiac Rehabilitation has on Functional Status after Cardiac Surgery using a questionnaire
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Scientific title
Assessing the Impact of Cardiac Rehabilitation on Functional Status Post-Surgery. A DASI (Duke Activity Status Index) Score Analysis in Adult Cardiac Surgery Patients: A pilot study.
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Secondary ID [1]
312883
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None
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Universal Trial Number (UTN)
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Trial acronym
DASI-AU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery
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Functional impairment before and after cardiac surgery
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Condition category
Condition code
Cardiovascular
331545
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0
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Coronary heart disease
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Physical Medicine / Rehabilitation
331618
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will engage in aerobic and resistance exercises tailored to accommodate sternal precautions. Each session begins with warm-up checks and personalized training tailored to the individual's baseline condition. The conditioning phase includes prolonged aerobic activity and progressive resistance training.
Each session is approximately 60 minutes in duration.
The exercise sessions are conducted in groups, with a staffing ratio of one instructor to every five participants.
Exercise intensity is individualized, beginning at low to moderate levels and progressing according to participant tolerance. The intensity is assessed using the Borg Category Scale, ranging from 'fairly light' (a perceived exertion level of about 13, 'somewhat hard') to 'hard' (15 on the Borg Scale) for those who can tolerate more vigorous activity. This assessment is complemented by monitoring heart rate responses and symptoms during exercise, conducted by exercise physiologists and physiotherapists specialized in cardiac rehabilitation.
Adherence to the intervention is monitored through documented attendance at each session, recorded in the hospital's electronic medical records.
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Intervention code [1]
329424
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Rehabilitation
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Comparator / control treatment
The control group consists of patients who will receive usual care but choose not to participate in a structured cardiac rehabilitation (CR) program but agree to participate in the study. They will be given standard post-operative care instructions, which include general advice on gradual physical activity resumption and lifestyle modifications, but without the structured support and tailored interventions provided to the intervention group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in functional status
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Assessment method [1]
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Duke Activity Status Index (DASI)
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Timepoint [1]
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Before surgery and after finishing 8-week cardiac rehabilitation program.
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Primary outcome [2]
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Quality of Life
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Assessment method [2]
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Quality of Life Scale (QOLS)
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Timepoint [2]
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Before surgery and after finishing 8-week cardiac rehabilitation program.
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Secondary outcome [1]
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Physical Fitness
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Assessment method [1]
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6-minute walk test
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Timepoint [1]
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Before surgery and after finishing 8-week cardiac rehabilitation program.
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Eligibility
Key inclusion criteria
Age and Health Status: Participants must be adults aged 70 and under who are scheduled for their first open cardiac surgery.
Cognitive and Language Requirements: Participants must be cognitively capable of giving informed consent and fluent in English to understand study procedures and communicate effectively with the Coordinating Principal Investigator (CPI).
Patients must plan to have their rehabilitation at Fiona Stanley Hospital (FSH).
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria are patients <18 years old and having re-do operations,cardiac transplants patient or catheter-based interventions. Patients arriving at the hospital in circulatory arrest will be excluded, and all patients undergoing emergency operations will be excluded.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary statistical approach for this trial will involve using descriptive statistics to summarise baseline characteristics and other demographic data. This will clearly understand the participant population and ensure valid comparisons between groups.
We will employ inferential statistics to analyse the primary efficacy parameters, such as DASI scores and QOLS changes. Comparative analyses between the intervention and control groups will be conducted using t-tests or ANOVA for continuous data, depending on the distribution of the data, and chi-square tests for categorical data. Additionally, we will utilise regression analysis to adjust for potential confounding variables and assess cardiac rehabilitation's independent effects on the outcomes. This will allow us to control for variables that could influence the results, such as age, baseline health status, and severity of cardiac disease.
For the intention-to-treat analysis, which includes all randomised participants regardless of protocol adherence, we will use techniques appropriate for dealing with missing data, such as multiple imputation. This analysis will ensure that our findings are robust and generalise to a broader patient population.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
31/01/2025
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Actual
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Date of last data collection
Anticipated
31/03/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
43133
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Western Norway University of Applied Sciences
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Address [1]
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Country [1]
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Norway
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Primary sponsor type
University
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Name
Western Norway University of Applied Sciences
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Address
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Country
Norway
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Secondary sponsor category [1]
319607
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None
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Name [1]
319607
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Address [1]
319607
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Country [1]
319607
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Other collaborator category [1]
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University
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Name [1]
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Curtin University
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Address [1]
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Country [1]
283178
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Australia
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Other collaborator category [2]
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Hospital
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Name [2]
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Fiona Stanley Hospital
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Address [2]
283186
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Country [2]
283186
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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15/07/2024
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Approval date [1]
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02/09/2024
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Ethics approval number [1]
316054
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RGS0000006884
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Summary
Brief summary
We are conducting a pilot study to see how well a cardiac rehabilitation program helps patients recover after open heart surgery. We will use the Duke Activity Status Index (DASI) tool to measure how much the program improves your ability to perform daily activities. This study aims to gather early information to understand how cardiac rehabilitation might help patients get better after their surgery. We are also interested in learning about the recovery of patients who choose not to participate in a cardiac rehabilitation program. This will help us compare the outcomes of those who do and do not participate in the rehabilitation program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Andrew Maiorana
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Address
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Curtin University, GPO Box U1987, Perth, Western Australia, 6845
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Country
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Australia
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Phone
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+61433567369
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Michael Mortensen
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Address
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Curtin University, GPO Box U1987, Perth, Western Australia, 6845
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Country
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Australia
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Phone
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+61 473106293
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Michael Mortensen
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Address
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Curtin University, GPO Box U1987, Perth, Western Australia, 6845
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Country
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Australia
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Phone
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+61 473106293
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Only a pilot study
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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.
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