ANZCTR - Registration

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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

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]

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

Cardiac surgeries via median sternotomy

Dementia

Mild cognitive impairment

Condition category

Condition code

Cardiovascular

Coronary heart disease

Neurological

Dementias

Physical Medicine / Rehabilitation

Physiotherapy

Surgery

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]

Rehabilitation

Intervention code [2]

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]

Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog)- the change from pre-surgery cognitive score.

Timepoint [1]

Baseline (pre-surgery) and 6 months post-intervention

Secondary outcome [1]

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]

6 months post-intervention

Secondary outcome [2]

Functional Status- Functional Disability Questionnaire

Timepoint [2]

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]

Independent Living- Lawton & Brody IADL scale

Timepoint [3]

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]

Post-operative Quality of Recovery Scale (PostopQRS)

Timepoint [4]

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]

Mini Mental State Examination (MMSE)

Timepoint [5]

Baseline (pre-surgery) and 6 month follow-up

Secondary outcome [6]

Lung Capacity- VO2 peak

Timepoint [6]

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]

Muscular strength- isometric muscular strength and hand grip strength tests.

Timepoint [7]

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]

Dynamic balance- four square step test

Timepoint [8]

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]

Sternal stability- assessed with the Sternal Instability Scale (manual palpation) and sternal ultrasound.

Timepoint [9]

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]

Body composition- assessed via height and weight to determine body mass index and waist circumference.

Timepoint [10]

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]

Participant satisfaction- assessed qualitatively via nine questions, asked post-intervention (14-15 weeks post-surgery).

Timepoint [11]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/03/2018

Actual

7/05/2018

Date of last participant enrolment

Anticipated

27/09/2019

Actual

22/08/2019

Date of last data collection

Anticipated

29/02/2020

Actual

14/02/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Melbourne Private Hospital - Parkville

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Royal Melbourne Hospital

Recruitment postcode(s) [2]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Melbourne

Address [1]

UoM Department of Surgery
Level 6, Centre for Medical Research
Royal Parade, Parkville VIC 3050

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Kieser Australia

Address [2]

41 Cecil St, South Melbourne VIC 3205

Country [2]

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]

Hospital

Name [1]

Royal Melbourne Hospital

Address [1]

300 Grattan St, Parkville VIC 3050

Country [1]

Australia

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Kieser Australia

Address [1]

41 Cecil St, South Melbourne VIC 3205

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Swinburne University of Technology

Address [2]

John St, Hawthorn, VIC 3122

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

300 Grattan St, Parkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/09/2017

Approval date [1]

30/11/2017

Ethics approval number [1]

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]

/AnzctrAttachments/373769-2017.266 SEcReT Protocol.docx (Protocol)

Attachments [2]

/AnzctrAttachments/373769-2017.266 SEcReT PICF Master.docx (Participant information/consent)

Attachments [3]

/AnzctrAttachments/373769-2017.266 Ethics Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Colin Royse

Address

The Royal Melbourne Hospital
PO Box 2135, Parkville VIC 3050

Country

Australia

Phone

+61408467548

Fax

colin.royse@heartweb.com

Contact person for public queries

Name

Lynda Tivendale

Address

The Royal Melbourne Hospital
PO Box 2135, Parkville VIC 3050

Country

Australia

Phone

+61393428908

Fax

lynda.tivendale@mh.org.au

Contact person for scientific queries

Name

Doa El-Ansary

Address

The Royal Melbourne Hospital
PO Box 2135, Parkville VIC 3050

Country

Australia

Phone

+61422036899

Fax

d.el-ansary@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1892	Informed consent form					373769-(Uploaded-16-04-2019-14-59-01)-Study-related document.pdf
1893	Ethical approval					373769-(Uploaded-17-05-2019-09-56-27)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (the SEcReT study): Protocol for a randomised controlled pilot study.	2020	https://dx.doi.org/10.1186/s13063-020-04558-x
Embase	Safety and feasibility of early resistance training following median sternotomy: The safe-arms study.	2020	https://dx.doi.org/10.1097/HCR.0000000000000556
Embase	Effects of 12-Week Supervised Early Resistance Training (SEcReT) Versus Aerobic-Based Rehabilitation on Cognitive Recovery Following Cardiac Surgery via Median Sternotomy: A Pilot Randomised Controlled Trial.	2022	https://dx.doi.org/10.1016/j.hlc.2021.08.023

N.B. These documents automatically identified may not have been verified by the study sponsor.

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