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Trial registered on ANZCTR


Registration number
ACTRN12617001430325
Ethics application status
Approved
Date submitted
5/10/2017
Date registered
9/10/2017
Date last updated
27/02/2020
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
4/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Supervised Early Resistance Training (SEcReT) Study: progressive resistance training following open heart surgery.
Scientific title
The Supervised Early Resistance Training (SEcReT) Study: progressive resistance training following median sternotomy.
Secondary ID [1] 293063 0
Nil known
Universal Trial Number (UTN)
U1111-1203-2131
Trial acronym
SEcReT
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 304994 0
Cardiac surgeries via median sternotomy 304995 0
Dementia 304996 0
Mild cognitive impairment 304997 0
Condition category
Condition code
Cardiovascular 304316 304316 0 0
Coronary heart disease
Neurological 304317 304317 0 0
Dementias
Physical Medicine / Rehabilitation 304318 304318 0 0
Physiotherapy
Surgery 304345 304345 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials: Participants will be given an appointment card listing the dates and times of their sessions and a map of the centre location.
Procedures: Whole body resistance training
Staff: Delivered by a physiotherapist with over 30 years experience and an exercise physiologist with 2 years experience.
Mode of Delivery: face to face (Individual 1:1 for weeks 1-4 and small group 1:4 for weeks 5-12).
Duration, Intensity & Dose: 24 x 30-45 minute sessions at a moderate intensity, 2x per week for 12 weeks.
Location: 1 of 3 Kieser Australia centres (Essendon, South Melbourne or Caulfield)- chosen based on geographical proximity to the patient's home address.
Exercise Sessions:
-Pre-exercise: heart rate, blood pressure and oxygen saturation taken at rest.
-30-40 minutes of whole body resistance training. Participants will spend 90-120 seconds on each exercise machine with 1-3 minutes rest between each exercise. The rest will include active recovery (i.e. walking between machines) and passive recovery (seated rest). Performed at an RPE of 13-16 on the Borg 6-20 Rating of Perceived Exertion scale. The first 60 seconds of each exercise is aimed to progressively warm-up the muscles. For this reason an additional warm-up will not be performed.
-5 mins cool-down: walking at an RPE 6-8 (very light) and passive recovery. Oxygen saturation, blood pressure and heart rate will be monitored for return to baseline levels..
Exercise format/progression:
The program will commence with 6-8 exercises for weeks 1-3 and progress to 8-10 exercises by week 4. Transition time between exercises will be reduced from 2-3 minutes to 1-2 minutes in the 4th week.
One set of each exercise will be performed to the point of local muscular fatigue (90-120 seconds), at a 4-2-4 cadence (4 second concentric contraction, 2 second isometric hold, 4 second eccentric contraction). To apply progressive overload, initial weights will be chosen and then progressed, using the formula that if the exercise can be completed for 120 seconds, within the intensity guidelines, the weight will be increased by 1–2 kg. The physical outcome measures obtained pre-intervention and mid-intervention will help to determine the initial weights selected and when the exercise programs need to be progressed.
Exercises:
Exercises may include: hip abduction, hip adduction, leg press, knee extension, lumbar extension, seated row and chest press. They have been selected based on the muscle groups that they isolate. The machines are specialised to allow the weight to be evenly applied to the target muscles throughout the entire range of movement.

Intervention code [1] 299306 0
Rehabilitation
Intervention code [2] 299307 0
Prevention
Comparator / control treatment
Standard care following coronary artery bypass grafting usually involves referral to a community-based cardiac rehabilitation program.
Procedures: Aerobic training and education for secondary prevention
Mode of Delivery: face to face in a group (usually up to 10 participants)
Duration, Intensity & Dose: low intensity aerobic exercise and education typically 2-3 times per weeks for 60-180 minutes, for 6-10 weeks.
Education: will include information for secondary prevention. This may include information on the condition (coronary artery disease), medication, nutrition, physical activity, how to improve lifestyle behaviours. The information delivered will be determined by the community rehabilitation service that the patient is referred to. This will not be run by the trial investigators.
Control group
Active

Outcomes
Primary outcome [1] 303585 0
Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog)- the change from pre-surgery cognitive score.
Timepoint [1] 303585 0
Baseline (pre-surgery) and 6 months post-intervention
Secondary outcome [1] 339476 0
Major adverse cardiac and cerebral events (MACCE)- This is a composition outcomes which will include all-cause mortality, cerebral vascular event (stroke), documented myocardial infarction, or repeat coronary intervention (percutaneous coronary intervention or redo cardiac surgery). It will be assessed via review of medical records.
Timepoint [1] 339476 0
6 months post-intervention
Secondary outcome [2] 339477 0
Functional Status- Functional Disability Questionnaire
Timepoint [2] 339477 0
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [3] 339478 0
Independent Living- Lawton & Brody IADL scale
Timepoint [3] 339478 0
Baseline (pre-surgery)
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [4] 339479 0
Post-operative Quality of Recovery Scale (PostopQRS)
Timepoint [4] 339479 0
Baseline (pre-surgery)
1-day post-op
3-5 days post-op
7 days post-op
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [5] 339480 0
Mini Mental State Examination (MMSE)
Timepoint [5] 339480 0
Baseline (pre-surgery) and 6 month follow-up
Secondary outcome [6] 339481 0
Lung Capacity- VO2 peak
Timepoint [6] 339481 0
Baseline (pre-surgery)
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [7] 339482 0
Muscular strength- isometric muscular strength and hand grip strength tests.
Timepoint [7] 339482 0
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [8] 339585 0
Dynamic balance- four square step test
Timepoint [8] 339585 0
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [9] 339586 0
Sternal stability- assessed with the Sternal Instability Scale (manual palpation) and sternal ultrasound.
Timepoint [9] 339586 0
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [10] 339587 0
Body composition- assessed via height and weight to determine body mass index and waist circumference.
Timepoint [10] 339587 0
Pre-intervention (2-3 Weeks post-surgery)
Mid-intervention (8-9 weeks post-surgery)
Post-intervention (14-15 weeks post-surgery)
6 month follow-up
Secondary outcome [11] 369515 0
Participant satisfaction- assessed qualitatively via nine questions, asked post-intervention (14-15 weeks post-surgery).
Timepoint [11] 369515 0
12 weeks post-operatively (post-intervention)

Eligibility
Key inclusion criteria
Adults aged 18 years and older undergoing elective cardiac surgery (via sternotomy) who speak sufficient English to complete the outcome surveys, where there is sufficient time for the preoperative assessment and training practice will be included.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants where there is insufficient time or availability for preoperative (baseline) surveys, who have pre-existing dementia diagnosed, or who do not have sufficient English to complete the survey forms will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be concealed using double sealed opaque envelopes, as this is a small pilot study. Following recruitment, the exercise physiologist and physiotherapist will be informed and they will be given the allocation and then arrange for the preoperative education session if allocation is to the intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation codes will be computer generated in uneven blocks. The allocation sequence will be concealed by the web-based enrolment system. 1:1 allocation ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The surgical team will be blinded to allocation. The patient and physiotherapy team will not be blinded. The accredited exercise physiologist or physiotherapist will conduct the secondary outcome assessment for muscle strength outcomes, which will be unblinded.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
As the effect size is currently unknown, we aim to perform a pilot study to determine group separation and feasibility. The results will allow sample size estimates for future definitive trials. A minimum sample size of 20 participants was deemed feasible for the institutions and resources.

The analysis will be descriptive, as the size of the pilot study will preclude definitive outcome analysis. The data will be reported in terms of group separation with odds ratio and confidence intervals. The following parameters would indicate clinically important relative differences between groups:
• ADAS-cog: difference of at least 2 on the ADAS-cog scale;
• VO2peak: relative difference in VO2peak between groups of 3mL/kg/min; and,
• Muscular strength: 15% or greater improvement in strength.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9158 0
Melbourne Private Hospital - Parkville
Recruitment hospital [2] 9159 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 17671 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 17672 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 297686 0
University
Name [1] 297686 0
The University of Melbourne
Address [1] 297686 0
UoM Department of Surgery
Level 6, Centre for Medical Research
Royal Parade, Parkville VIC 3050
Country [1] 297686 0
Australia
Funding source category [2] 297710 0
Commercial sector/Industry
Name [2] 297710 0
Kieser Australia
Address [2] 297710 0
41 Cecil St, South Melbourne VIC 3205
Country [2] 297710 0
Australia
Primary sponsor type
Individual
Name
Professor Colin Royse
Address
The Royal Melbourne Hospital
PO Box 2135, Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 296706 0
Hospital
Name [1] 296706 0
Royal Melbourne Hospital
Address [1] 296706 0
300 Grattan St, Parkville VIC 3050
Country [1] 296706 0
Australia
Other collaborator category [1] 279759 0
Commercial sector/Industry
Name [1] 279759 0
Kieser Australia
Address [1] 279759 0
41 Cecil St, South Melbourne VIC 3205
Country [1] 279759 0
Australia
Other collaborator category [2] 280652 0
University
Name [2] 280652 0
Swinburne University of Technology
Address [2] 280652 0
John St, Hawthorn, VIC 3122
Country [2] 280652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298758 0
Melbourne Health
Ethics committee address [1] 298758 0
300 Grattan St, Parkville VIC 3050
Ethics committee country [1] 298758 0
Australia
Date submitted for ethics approval [1] 298758 0
26/09/2017
Approval date [1] 298758 0
30/11/2017
Ethics approval number [1] 298758 0
2017.266

Summary
Brief summary
Heart disease is the number one killer worldwide, with over one million cardiac operations performed each year. Patients undergoing cardiac surgery are typically elderly with multiple health conditions. Whilst cerebral (brain) complications such as stroke are infrequent (3%), a decline in cognitive (brain) function is more prevalent following surgery with reports that concentration, focus, cognitive processing speed and short-term memory is impaired in 15–40% of patients at 3 months or longer after surgery (Ahlgren et al., 1998; Roach et al., 1996; Newman et al., 2001; Royse A et al., 2000). This permanent loss of cognitive function is even higher in elderly patients (Moller et al., 1998; Benvenuti et al., 2014; Royse C et al., 2011), and results in disability and loss of independence. It may also accelerate the incidence of dementia, as high as 30% in patients 7.5 years after cardiac surgery (Evered et al., 2016).
Dementia occurs in approximately 9% of the general population over the age of 65 years, causing substantial personal and family suffering, and a high cost to the health care system. Within the next 20 years, 100 million people are predicted to have dementia, which will pose a serious challenge for the health care system (Andrieu et al., 2009). Furthermore evidence of mild cognitive impairment (MCI), considered a precursor to dementia, is evident in 30-50% of patients prior to undergoing cardiac surgery (Royse C et al., 2017). Preventing further deterioration of cognitive function after surgery is therefore critical in reducing dementia in this vulnerable cohort.
Previous studies have shown that exercise preserves or even improves cognitive function (Vaynman et al., 2004), as well as reducing long term cognitive decline (Liu-Ambrose et al., 2010; Hamer et al., 2009). This study will look at the effect of early weight training exercise, requiring an increased effort and heart rate, following open heart surgery. We aim to determine if there is an optimal dose (type, intensity and duration of exercise) to maximize cognitive and physical health benefits. Participants will be randomly assigned (like tossing a coin) to either a 12-week moderate intensity weight training program or to a 6-week low-intensity exercise program (usual care). Participants in both groups will attend twice weekly exercise rehabilitation, lasting for approximately 60 minutes per session (12-24 sessions). All exercise sessions will be supervised by an accredited exercise physiologist or physiotherapist to ensure patient safety. We predict that the weight training intervention will prevent further cognitive decline, and result in significantly greater improvements in patient-reported recovery, exercise ability and muscular strength up to 6 months after surgery. We anticipate that the participants will return to pre-disease levels of health and function or better.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2097 2097 0 0
Attachments [2] 2098 2098 0 0
/AnzctrAttachments/373769-2017.266 SEcReT PICF Master.docx (Participant information/consent)
Attachments [3] 2418 2418 0 0

Contacts
Principal investigator
Name 78134 0
Prof Colin Royse
Address 78134 0
The Royal Melbourne Hospital
PO Box 2135, Parkville VIC 3050
Country 78134 0
Australia
Phone 78134 0
+61408467548
Fax 78134 0
Email 78134 0
colin.royse@heartweb.com
Contact person for public queries
Name 78135 0
Mrs Lynda Tivendale
Address 78135 0
The Royal Melbourne Hospital
PO Box 2135, Parkville VIC 3050
Country 78135 0
Australia
Phone 78135 0
+61393428908
Fax 78135 0
Email 78135 0
lynda.tivendale@mh.org.au
Contact person for scientific queries
Name 78136 0
Dr Doa El-Ansary
Address 78136 0
The Royal Melbourne Hospital
PO Box 2135, Parkville VIC 3050
Country 78136 0
Australia
Phone 78136 0
+61422036899
Fax 78136 0
Email 78136 0
d.el-ansary@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will only be made available upon request to the Chief Investigator and will be granted at their discretion.
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1892 0
Informed consent form
Citation [1] 1892 0
Link [1] 1892 0
Email [1] 1892 0
Other [1] 1892 0
Type [2] 1893 0
Ethical approval
Citation [2] 1893 0
Link [2] 1893 0
Email [2] 1893 0
Other [2] 1893 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary