Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001351101
Ethics application status
Approved
Date submitted
21/08/2019
Date registered
1/10/2019
Date last updated
25/11/2021
Date data sharing statement initially provided
1/10/2019
Date results information initially provided
19/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between cardiorespiratory parameters during physical activity following cardiac surgery
Scientific title
The relationship between cardiorespiratory parameters of heart rate, oxygen saturations and respiratory during physical activity following cardiac surgery
Secondary ID [1] 299086 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery bypass graft 314125 0
Cardiac valve replacement 314126 0
Cardiac valve repair 314442 0
Condition category
Condition code
Cardiovascular 312502 312502 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will undertake a test of their physical function and exercise (mobilisation). Although the exercise is considered usual physiotherapy care after cardiac surgery, completing the test of physical function is not part of usual care.
The test of physical function will be the short physical performance battery and will include a measure of walking speed, lower limb strength assessment during a sit-to-stand activity and a measure of balance.
The exercise undertaken will be walking performed on the ward, the distance and intensity determined by the physiotherapist. The exercise prescription and completion of the short physical performance battery will be administered by the participant's treating physiotherapist.
The exercise and test of physical activity will take approximately 20 minutes maximum to complete and will be undertaken at Day 3 post cardiac surgery, on the ward.
During the exercise and test of physical function, cardiorespiratory parameters (heart rate, respiratory rate and oxygen saturation) will be measured and the levels of perceived exertion and dyspnoea will be recorded.
Intervention code [1] 315357 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321135 0
Cardiorespiratory parameter of heart rate. This will be recorded using the IntelliVue telemetry system to which the participant is connected while an inpatient on the ward.
Timepoint [1] 321135 0
Day 3 post cardiac surgery
Primary outcome [2] 321400 0
Cardiorespiratory parameter of oxygen saturation. This will be recorded using the IntelliVue telemetry system to which the participant is connected while an inpatient on the ward.
Timepoint [2] 321400 0
Day 3 post cardiac surgery
Primary outcome [3] 321401 0
Cardiorespiratory parameter of respiratory rate. This will be recorded using the IntelliVue telemetry system to which the participant is connected while an inpatient on the ward.
Timepoint [3] 321401 0
Day 3 post cardiac surgery
Secondary outcome [1] 374102 0
Measure of dyspnoea during exercise. This will be measured using the modified Borg dyspnoea scale by the participant's treating physiotherapist.
Timepoint [1] 374102 0
Day 3 post cardiac surgery
Secondary outcome [2] 374877 0
Results of the Short Physical Performance Battery test. This will be measured by the participants' treating physiotherapist and will include measures of walking speed over 4 metres, standing balance and lower limb strength tested by repetitive sit-to-stand activities
Timepoint [2] 374877 0
Day 3 post cardiac surgery
Secondary outcome [3] 375144 0
Measure of perceived exertion during exercise. This will be measured using the Borg rating of perceived exertion by the participant's treating physiotherapist.
Timepoint [3] 375144 0
Day 3 post cardiac surgery

Eligibility
Key inclusion criteria
Elective coronary artery bypass grafting or valve replacement or repair
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have undergone elective or emergent cardiac surgery and who have an implanted pacemaker, chronic disturbances in heart rhythm prior to surgery, prolonged ICU stay for haemodynamic or respiratory instability or the inability to undertake exercise safety.

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
Data will be described using mean±SD or median±interquartile range depending on the data distribution. Relationship between cardiorespiratory parameters and exercise intensity and cardiorespiratory parameters and the SPPB total score will be analysed by Spearman’s rho or Pearson’s correlation coefficient, with alpha set at 0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2019
Actual
14/10/2019
Date of last participant enrolment
Anticipated
24/08/2020
Actual
14/04/2020
Date of last data collection
Anticipated
31/08/2020
Actual
15/04/2020
Sample size
Target
47
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14607 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 27628 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 303624 0
Charities/Societies/Foundations
Name [1] 303624 0
Cabrini Foundation
Country [1] 303624 0
Australia
Primary sponsor type
Individual
Name
Annemarie Lee
Address
Cabrini Health
154 Wattletree Road,
Malvern, 3144, Victoria
Country
Australia
Secondary sponsor category [1] 303714 0
None
Name [1] 303714 0
Address [1] 303714 0
Country [1] 303714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304150 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 304150 0
Cabrini Health
154 Wattletree Road
Malvern, 3144, Victoria
Ethics committee country [1] 304150 0
Australia
Date submitted for ethics approval [1] 304150 0
31/07/2019
Approval date [1] 304150 0
17/09/2019
Ethics approval number [1] 304150 0

Summary
Brief summary
Exercise is undertaken as part of usual physiotherapy care following heart surgery. While it is considered safe, the exact effects of exercise which is commony prescribed following heart surgery by physiotherapists on heart function, breathing rates and oxygen levels are unknown. Establishing this information will further inform exercise prescription guidelines for physiotherapists who care for people following heart surgery. The aim of this study is to determine the relationship between heart rate, respiratory rate and oxygen saturation and measures of physical function and exercise intensity following heart surgery. People who have undergone heart surgery and require physiotherapy following surgery will be recruited for this study. During the usual physiotherapy tasks which involves exercise, and tests of balance and leg strength, measurements of heart function, breathing rate and oxygen levels will be extracted from the continuous monitoring system of which all people following cardiac surgery are connected to. Participants will be asked to rate their level of breathlessness and exertion following exercise. The relationship between exercise intensity and measures of heart function, breathing rate and oxygen saturations will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95970 0
Dr Annemarie Lee
Address 95970 0
Cabrini Health
154 Wattletree Road
Malvern 3144, Victoria
Country 95970 0
Australia
Phone 95970 0
+61 03 9508 3423
Fax 95970 0
Email 95970 0
AnnemarieLee@cabrini.com.au
Contact person for public queries
Name 95971 0
Dr Annemarie Lee
Address 95971 0
Cabrini Health
154 Wattletree Road
Malvern 3144, Victoria
Country 95971 0
Australia
Phone 95971 0
+61 03 9508 3423
Fax 95971 0
Email 95971 0
AnnemarieLee@cabrini.com.au
Contact person for scientific queries
Name 95972 0
Dr Annemarie Lee
Address 95972 0
Cabrini Health
154 Wattletree Road
Malvern 3144, Victoria
Country 95972 0
Australia
Phone 95972 0
+61 03 9508 3423
Fax 95972 0
Email 95972 0
AnnemarieLee@cabrini.com.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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Giacchi M, Nguyen M-T, Gaudin J, Bergin M, Collico... [More Details]
Plain language summaryNo Forty-five participants completed the study. Heart... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe relationship between cardiorespiratory parameters, mobilisation and physical function following cardiac surgery.2022https://dx.doi.org/10.1080/21679169.2021.1942195
N.B. These documents automatically identified may not have been verified by the study sponsor.