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Trial registered on ANZCTR


Registration number
ACTRN12616000102471
Ethics application status
Approved
Date submitted
25/01/2016
Date registered
1/02/2016
Date last updated
8/01/2020
Date data sharing statement initially provided
12/12/2018
Date results information initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Water-based exercise training in people with stable coronary heart disease- Study B
Scientific title
A randomised, controlled trial of water-based exercise training in people with stable coronary heart disease (Study B)
Secondary ID [1] 288132 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 297011 0
Condition category
Condition code
Cardiovascular 297258 297258 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study B is part of a broader project investigating the effects of water-based exercise in people with coronary heart disease. This study will involve a 12 week randomised controlled trial involving participants who will be randomised into one of three groups:
*12 weeks of land-based exercise
* 12 weeks of water-based exercise
* A control group who will maintain their usual activities for 12 weeks.

The training groups will be supervised by a health professional (majority of sessions supervised by a physiotherapist) and group training sessions (maximum of 10 participants) will be conducted three times per week, for one hour and 10 minute sessions, for 12 weeks (36 sessions total).
The training programs will commence and conclude with 5 minutes of light aerobic activity (e.g. walking) and stretching. Moderate intensity exercises will alternate resistance (strength) and aerobic (fitness) stations. There will be 7 resistance and 8 aerobic stations lasting for 90 seconds, with 30 seconds of active recovery between exercises. Participants will build up to completing 2 circuits per session. During water-based exercise participants will be submerged to their xiphoid process (lower chest) in a heated swimming pool.
Aerobic exercises will be monitored and matched by heart rate (60-80% of a participant’s heart rate maximum) and rating of perceived exertion (11-14 rating on the Borg Rating of Perceived Exertion Scale). Training will commence at approximately 60% of participants’ VO2peak and progress to 80% over the course of the training, as individually tolerated. Water-based aerobic exercises will include jogging, quick stepping/ jumping and high knees. Land-based aerobic exercises will include cycling, treadmill jogging and recumbent cycling.
Resistance exercises will be matched for muscle group, Borg rating (between 11-14) and quantified resistance per station. Water-based exercises will utilise custom-designed resistance equipment (paddles), developed by this research team previously. Water-based resistance exercises will include; shoulder flexion and extension, shoulder abduction and adduction, hip flexion and extension, knee flexion and extension and hip abduction. Land-based exercises will include; shoulder flexion/ extension, modified shoulder abduction/ adduction, knee extension, hamstring curls, hip flexion/ extension and hip abduction. Resistance will be provided by machines, pulleys, free weights and ankle weights and the weight lifted can be used to quantify resistance.
Participant attendance will be recorded for each session, as will a selection of perceived exertion, heart rate and resistance measures for each session.

Strength, fitness, vascular function, brain blood flow, body composition, blood profiles and elements of cognition will be assessed before and after the 12 week period. Vascular function will be assessed fortnightly during the 12 week period in a subgroup of 14 participants from each of the training groups. Participants will be invited to take part in this as they enroll chronologically, until we reach the 14 participants required.
Intervention code [1] 293442 0
Rehabilitation
Intervention code [2] 293765 0
Treatment: Other
Comparator / control treatment
The randomised controlled trial will compare water-based exercise to both land-based exercise (conventional treatment) and a usual activities control group
Control group
Active

Outcomes
Primary outcome [1] 296846 0
Flow mediated dilation (FMD) of the brachial artery will be used to assess endothelial function. A 10MHz multi-frequency linear array probe attached to a high resolution ultrasound machine (T3000; Terason, Burlington, Massachusetts, USA) will record baseline images of the brachial artery for one minute. FMD will subsequently be assessed by inflating a blood pressure cuff to 200mmHg over the proximal forearm for 5 minutes. Recording of the artery will commence 30 seconds prior to cuff deflation and will continue for 3 minutes post deflation. Custom designed edge detection and tracking software will be used to analyse the images.
Timepoint [1] 296846 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [1] 319504 0
Cerebral blood flow, (CBF) will be assessed using transcranial doppler ultrasound
Timepoint [1] 319504 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [2] 320285 0
Muscular strength by assessing 1 repetition maximum strength for leg press and latissimus dorsi using weights machines.
Timepoint [2] 320285 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [3] 320286 0
Aerobic capacity (VO2peak) will be assessed using the Modified Chronotropic Protocol on a treadmill. Indirect calorimetry will be employed to assess the participant’s VO2 peak.
Timepoint [3] 320286 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [4] 320287 0
Body mass index (BMI) will be calculated from weight (measured using electronic scales) and height (measured using a stadiometer)
Timepoint [4] 320287 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [5] 320288 0
Vascular function- Flow Mediated Dilation (FMD) of the brachial artery (as per primary outcome) will be assessed fortnightly in a subgroup of participants using ultrasound.
Timepoint [5] 320288 0
Every second week throughout the 12 week intervention period in a subgroup of the training groups (14 per group)
Secondary outcome [6] 320289 0
Blood profiles: Assessment will include a full blood picture (baseline only), urea and electrolytes, liver function, C-reactive protein, cholesterol, triglycerides, low density lipoprotein cholesterol and high density lipoprotein cholesterol. These will be assessed externally by PathWest.
Timepoint [6] 320289 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [7] 320290 0
Elements of cognition, such as reaction speed, will be assessed using specialised CogState software.
Timepoint [7] 320290 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [8] 320318 0
Waist and hip circumference will be measured using a steel measuring tape
Timepoint [8] 320318 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.
Secondary outcome [9] 320319 0
Endothelium independent vascular function of the brachial artery- A 10MHz multi-frequency linear array probe attached to a high resolution ultrasound machine (T3000; Terason, Burlington, Massachusetts, USA) will record baseline images of the brachial artery for one minute. Subsequently a 400µg sublingual dose of glyceryl trinitrate (GTN) will be administered. Imaging will recommence 3 minutes post administration for 5 minutes to ensure the peak dilation is captured. Custom designed software will be used to analyse the images.
Timepoint [9] 320319 0
This will be measured at baseline (week 0) and at the end of the 12 week randomised controlled trial.

Eligibility
Key inclusion criteria
*Stable, documented coronary heart disease and be at least 6 months following a myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention
* Have been taking stable medical therapy for the last 2 months
* Be able to participate in exercise training 3 days per week and organise their own transport
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Renal impairment, hepatic impairment, proteinurea or hyperuricaemia
* Left ventricle ejection fraction below 45%
* Musculoskeletal or neurological condition or injury that precludes exercise training
* Any current or recent neoplasms or cancer treatment
* Current smokers
* Premenopausal females (due to the potential effects of hormonal cycle on vascular assessment)
*Currently participating in a formal exercise program at least 3 times per week, or have done so in the last 6 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will select a sealed envelope with their allocation at the first testing session to allocate to group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be recruited using a rolling enrollment, as such we will be using block randomisation. Each block will contain even allocations for each group (water-based training, land based training or usual activities) for the study. This will ensure approximately even subject numbers per group for the duration of the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features


Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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)
WA
Recruitment hospital [1] 4928 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 4929 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 292540 0
University
Name [1] 292540 0
Curtin University
Address [1] 292540 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country [1] 292540 0
Australia
Funding source category [2] 301431 0
Charities/Societies/Foundations
Name [2] 301431 0
Heart Foundation (Vanguard Grant)
Address [2] 301431 0
C/O Heart Foundation WA Division
PO Box 1133, Subiaco WA 6904
Country [2] 301431 0
Australia
Funding source category [3] 301432 0
Charities/Societies/Foundations
Name [3] 301432 0
Spinnaker Health Research Foundation
Address [3] 301432 0
PO Box 480
Fremantle WA 6959
Country [3] 301432 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 291257 0
None
Name [1] 291257 0
Address [1] 291257 0
Country [1] 291257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294014 0
Royal Perth Hospital Human Research Ethics Committee, EC00270
Ethics committee address [1] 294014 0
Southern Integrated Research Organisation (SIRO)
Locked Bag 100, PALMYRA DC WA 6961
Ethics committee country [1] 294014 0
Australia
Date submitted for ethics approval [1] 294014 0
Approval date [1] 294014 0
04/12/2015
Ethics approval number [1] 294014 0
REG 15-165
Ethics committee name [2] 294015 0
Curtin University
Ethics committee address [2] 294015 0
Kent Street, Bentley, Perth, Western Australia, 6102
Ethics committee country [2] 294015 0
Australia
Date submitted for ethics approval [2] 294015 0
10/12/2015
Approval date [2] 294015 0
15/12/2015
Ethics approval number [2] 294015 0
HR227/2015

Summary
Brief summary
Aims:
The aim of this project is to assess the effects of water-based exercise training in people with stable heart disease. This study is being conducted in conjunction with an acute study assessing the physiological effects of a single submerged session compared to a single session of matched intensity land-based exercise.
Justification:
Exercise is an important component of rehabilitation and preventing recurrent heart problems in people with heart disease. However, exercise participation is sub-optimal in this population and increasing the range of exercise options for people with heart disease may increase exercise participation. For example, water-based exercise may be more appealing to people with heart disease who have other health issues, such as arthritis or obesity, which may make land-based exercise difficult or painful. Furthermore, preliminary research suggests that water-based exercise may have additional vascular and brain benefits due to the effects of water immersion on blood flow. However, this has not previously been investigated in people with heart disease.
Participants:
Patients who have had a heart attack or bypass surgery at least six months prior to enrolment, or documented blockages in the arteries of their heart based on the results of an angiogram (a scan of the heart) will be recruited to the study. Participants must be medically stable prior to participation and not be undertaking a formal exercise program.
Design and methods:
60 participants will be randomised into one of three groups for the duration of a 12 week program:
*12 weeks of land-based exercise
* 12 weeks of water-based exercise
* A control group who will maintain their usual activities for 12 weeks.
Strength, fitness, vascular function, brain blood flow, body composition, blood profiles and aspects of cognition will be assessed before and after the 12 week period. Vascular function will be assessed fortnightly during the 12 week period in a subgroup of participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62150 0
A/Prof Andrew Maiorana
Address 62150 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country 62150 0
Australia
Phone 62150 0
+61433567369
Fax 62150 0
Email 62150 0
a.maiorana@curtin.edu.au
Contact person for public queries
Name 62151 0
Mrs Anna Scheer
Address 62151 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country 62151 0
Australia
Phone 62151 0
+61452236661
Fax 62151 0
Email 62151 0
anna.scheer@postgrad.curtin.edu.au
Contact person for scientific queries
Name 62152 0
Mrs Anna Scheer
Address 62152 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country 62152 0
Australia
Phone 62152 0
+61452236661
Fax 62152 0
Email 62152 0
anna.scheer@postgrad.curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial underlying published results, after de-identification.
When will data be available (start and end dates)?
After publication, subject to journal's requirements regarding embargo periods, with no end date determined yet.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by the Principal Investigator, Associate Professor Andrew Maiorana, School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Fax: +61 8 9266 3699 Telephone: +61 8 9266 9225 Email: A.Maiorana@curtin.edu.au
What supporting documents are/will be available?
No other documents available
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