Trial Review

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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
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.
Secondary ID [1] 312883 0
None
Universal Trial Number (UTN)
Trial acronym
DASI-AU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 335038 0
Functional impairment before and after cardiac surgery 335039 0
Condition category
Condition code
Cardiovascular 331545 331545 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 331618 331618 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329424 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 339290 0
Change in functional status
Timepoint [1] 339290 0
Before surgery and after finishing 8-week cardiac rehabilitation program.
Primary outcome [2] 339291 0
Quality of Life
Timepoint [2] 339291 0
Before surgery and after finishing 8-week cardiac rehabilitation program.
Secondary outcome [1] 439377 0
Physical Fitness
Timepoint [1] 439377 0
Before surgery and after finishing 8-week cardiac rehabilitation program.

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).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Educational / counselling / training
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
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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27066 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 43133 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 317324 0
University
Name [1] 317324 0
Western Norway University of Applied Sciences
Country [1] 317324 0
Norway
Primary sponsor type
University
Name
Western Norway University of Applied Sciences
Address
Country
Norway
Secondary sponsor category [1] 319607 0
None
Name [1] 319607 0
Address [1] 319607 0
Country [1] 319607 0
Other collaborator category [1] 283178 0
University
Name [1] 283178 0
Curtin University
Address [1] 283178 0
Country [1] 283178 0
Australia
Other collaborator category [2] 283186 0
Hospital
Name [2] 283186 0
Fiona Stanley Hospital
Address [2] 283186 0
Country [2] 283186 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316054 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 316054 0
Ethics committee country [1] 316054 0
Australia
Date submitted for ethics approval [1] 316054 0
15/07/2024
Approval date [1] 316054 0
02/09/2024
Ethics approval number [1] 316054 0
RGS0000006884

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136630 0
Prof Andrew Maiorana
Address 136630 0
Curtin University, GPO Box U1987, Perth, Western Australia, 6845
Country 136630 0
Australia
Phone 136630 0
+61433567369
Fax 136630 0
Email 136630 0
andrew.maiorana@health.wa.gov.au
Contact person for public queries
Name 136631 0
Michael Mortensen
Address 136631 0
Curtin University, GPO Box U1987, Perth, Western Australia, 6845
Country 136631 0
Australia
Phone 136631 0
+61 473106293
Fax 136631 0
Email 136631 0
miahm@hvl.no
Contact person for scientific queries
Name 136632 0
Michael Mortensen
Address 136632 0
Curtin University, GPO Box U1987, Perth, Western Australia, 6845
Country 136632 0
Australia
Phone 136632 0
+61 473106293
Fax 136632 0
Email 136632 0
miahm@hvl.no

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only a pilot study


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.