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Trial registered on ANZCTR


Registration number
ACTRN12625000313437
Ethics application status
Approved
Date submitted
1/04/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Is a resistance exercise program following cardiac surgery safe and acceptable?
Scientific title
The safety and patient perceived acceptability of a resistance exercise program commenced during the early recovery period following cardiac surgery
Secondary ID [1] 314101 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 336880 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333355 333355 0 0
Physiotherapy
Surgery 333356 333356 0 0
Other surgery
Cardiovascular 333357 333357 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will engage in light to moderate upper and lower limb resistance exercises using no or minimal equipment such as body weight resistance elasticated exercise bands under supervision during three supervised sessions: one during week 2, one during week 6 and one during week 10 post-cardiac surgery. Each session will be 45 minutes in duration. The participants will not be asked to undertake these exercises at any other time during the study period. The exercises will be undertaken one-on-one under the supervision of a physiotherapist. The exercises include bicep curls, shoulder flexion to 90 degrees, shoulder external rotation (with arms by the side), upright row, sit to stands, knee extensions, hamstring curls, calf raises, hip abduction and hip extension. At the week 10 session an additional exercise, wall pushups, will be added to the exercise protocol. Participants will perform 8-12 repetitions of each exercise at no greater than moderate intensity (5-6 out of 10 rating of perceived exertion or 4 repetitions in reserve). The primary objective of the study is to determine safety by measuring the amount of sternal edge movement occurring during the upper limb exercises at the three post-operative timepoints (weeks 2, 6 and 10). To assess sternal edge movement, during the upper limb exercises, the supervising physiotherapist will take ultrasound imaging recordings for analysis at a later stage to determine the amount of sternal edge movement taking place during each upper limb exercise. The supervising physiotherapist and the rest of the research team have all been trained in undertaking ultrasound sternal imaging. Secondary outcome measures to determine safety are pain and cardiovascular responses.
Intervention code [1] 330675 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340933 0
Sternal edge micromotion (primary outcome measure to determine safety)
Timepoint [1] 340933 0
During each session held during weeks 2, 6 and 10 post-cardiac surgery
Secondary outcome [1] 445512 0
Pain responses (specifically sternal wound pain responses during each upper limb exercise; if the participant has a surgical leg wound e.g. if they have undergone coronary artery bypass graft surgery, then pain responses during each lower limb exercise will also be assessed)
Timepoint [1] 445512 0
Weeks 2, 6 and 10 post-cardiac surgery. At each timepoint pain responses will be recorded following the completion of each exercise.
Secondary outcome [2] 445516 0
Blood pressure (to assess safety and monitor for adverse events)
Timepoint [2] 445516 0
At each session (taking place at weeks 2, 6 and 10 post-cardiac surgery), blood pressure will be measured before the exercises (baseline), at the completion of the upper limb exercises, and at the completion of the lower limb exercises.
Secondary outcome [3] 445517 0
Participant perceived acceptability
Timepoint [3] 445517 0
Within two weeks following the week 10 session.
Secondary outcome [4] 446007 0
Heart rate (to assess safety and monitor for adverse events)
Timepoint [4] 446007 0
At each session (weeks 2, 6 and 10 post-cardiac surgery) heart rate will be measured before the exercises (baseline), immediately after the upper limb exercises and immediately after the lower limb exercises.
Secondary outcome [5] 446008 0
Oxygen saturation (to assess safety and monitor for adverse events)
Timepoint [5] 446008 0
During each session (weeks 2, 6 and 10 post-cardiac surgery) oxygen saturation will be measured before the exercises (baseline), immediately after the upper limb exercises and immediately after the lower limb exercises.
Secondary outcome [6] 446009 0
Pulse rhythm (to assess safety and monitor for adverse events)
Timepoint [6] 446009 0
Pulse rhythm will be assessed during each session (at weeks 2, 6 and 10 post-cardiac surgery) immediately before the exercises (baseline), immediately after the upper limb exercises and immediately after the lower limb exercises.
Secondary outcome [7] 446012 0
Sternal wound instability (to monitor for adverse events)
Timepoint [7] 446012 0
Measured at each session (weeks 2, 6 and 10 post-cardiac surgery) at the start of the session and after the completion of the upper limb exercises.

Eligibility
Key inclusion criteria
Adults (18 years of age or over) awaiting either elective or emergency cardiac surgery (coronary artery bypass or heart valve surgery) at Dunedin Public Hospital who have no contraindications to participation in the opinion of the operating surgeon. Participants also need to live within a travelable distance (approximately 40 minutes) to the University of Otago, Dunedin to be able to take part in the in-person testing sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant post-operative medical complications (e.g., wound complications such as infection, severe pain or instability; and cardiovascular complications such as persistent cardiac arrhythmias or stroke). To ensure safety during the exercise testing, people will also be excluded from participation if they are unable to understand English or demonstrate impaired cognition and/or confusion. People with pre-existing muscle or joint problems that limit shoulder elevation up to 90° will be excluded from participating. People will also be excluded if they live too far away to travel to the testing facility (the research team have used up to 40-minute drive to invite people but people who live closer than this may still decide it is too far), or if they require taxi travel but live more than 20 km from the University of Otago (due to funding constraints). Participants may be withdrawn from the study by the operating surgeon at any time due to safety concerns.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Continuous demographic data will be reported using mean and standard deviation. Categorical demographic data will be reported using frequency, percentage and range. Changes in pain ratings will be reported using mean, standard deviation and range at each timepoint. The occurrence of adverse events (including type and severity) will be reported using frequency. For the ultrasound images, measurements will be reported using median, minimum and maximum values. A measurement of < 2mm has been proposed to ensure no disruption to sternal healing (McGregor et al., 1999). Intra- and inter-reliability will be assessed using intraclass correlation coefficients (ICCs) with a 95% confidence interval. Intra-rater reliability will be calculated using a consistency, 2-way mixed-effects model. The ICC inter-rater reliability will be calculated using a mean-rating (k=2), absolute-agreement, 2-way mixed effects model. These will then be compared against the ICC value classification as follows: 0.90=excellent

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
29/05/2026
Actual
Date of last data collection
Anticipated
14/08/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26929 0
New Zealand
State/province [1] 26929 0
Otago

Funding & Sponsors
Funding source category [1] 318608 0
University
Name [1] 318608 0
University of Otago Research Grant
Country [1] 318608 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321012 0
None
Name [1] 321012 0
Address [1] 321012 0
Country [1] 321012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317212 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317212 0
Ethics committee country [1] 317212 0
New Zealand
Date submitted for ethics approval [1] 317212 0
26/11/2024
Approval date [1] 317212 0
03/02/2025
Ethics approval number [1] 317212 0
2024 FULL 21815

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

Contacts
Principal investigator
Name 140358 0
Dr Emily Gray
Address 140358 0
School of Physiotherapy, University of Otago, 325 Great King Street, Dunedin, 9016
Country 140358 0
New Zealand
Phone 140358 0
+64 034797222
Fax 140358 0
Email 140358 0
[email protected]
Contact person for public queries
Name 140359 0
Emily Gray
Address 140359 0
School of Physiotherapy, University of Otago, 325 Great King Street, Dunedin, 9016
Country 140359 0
New Zealand
Phone 140359 0
+64 034797222
Fax 140359 0
Email 140359 0
[email protected]
Contact person for scientific queries
Name 140360 0
Emily Gray
Address 140360 0
School of Physiotherapy, University of Otago, 325 Great King Street, Dunedin, 9016
Country 140360 0
New Zealand
Phone 140360 0
+64 034797222
Fax 140360 0
Email 140360 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24588Ethical approval    Letter indicating approval from HDEC.pdf
24589Study protocol    Resistance exercise post sternotomy study protocol_full_final.pdf
24590Informed consent form    Resistance exercise after cardiac surgery participant-information-sheet-consent-form-final.pdf



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.