Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000113459
Ethics application status
Approved
Date submitted
28/01/2016
Date registered
2/02/2016
Date last updated
16/06/2021
Date data sharing statement initially provided
13/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Water-based exercise in people with stable coronary heart disease (Study A)
Scientific title
A randomised, controlled trial of water-based exercise training in people with stable coronary heart disease (Study A)
Secondary ID [1] 288425 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 297443 0
Condition category
Condition code
Cardiovascular 297632 297632 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover study assessing acute physiological responses, including brain and arm blood flow and systemic haemodynamics, to low (40% VO2peak) and moderate (60% VO2peak) intensity water-based exercise and matched intensity land-based exercise. This will involve one endurance capacity assessment to determine VO2peak and one exercise session per participant, where they will take part in both land and water-based exercise in a randomised order, in the same session, with a 20-30minute break between sessions, until measured variables return to baseline.
Participants will exercise with their arms supported at heart level and will be doing a high knees style aerobic exercise (similar to fast marching on the spot), with intensity monitored by a heart rate monitor (band across the chest and corresponding wrist watch), and VO2 (via mask) during the session. Participants will exercise for approximately 5 minutes at 40% of VO2 peak and 5 minutes at 60% of VO2 peak, before having a recovery period and seated rest for approximately 20-30 minutes, depending on baseline readings. After resting participants will take part in the same protocol for the other condition (wet or dry). Sessions will be supervised by a physiotherapist and exercise physiologist.
Intervention code [1] 293740 0
Rehabilitation
Comparator / control treatment
This is a crossover study, so all participants will undertake both the water-based and land-based exercise conditions. Land-based exercise is treated as the control condition here, as it is where conventional cardiac rehabilitation programs currently take place.
Control group
Active

Outcomes
Primary outcome [1] 297172 0
Cerebral blood flow (CBF) will be assessed using a 2MHz, pulsed ST3 transcranial ultrasound system (Spencer Technologies, Seattle, Washington, USA) to determine the velocity of the middle cerebral artery.
Timepoint [1] 297172 0
At the end of each intensity of exercise (40% and 60% of Vo2peak, for both immersed and dry exercise).
Secondary outcome [1] 320229 0
Brachial artery diameter and blood flow will be assessed using ultrasound and analysed with custom designed software. The results of blood flow and diameter readings will be interpreted together to examine endothelial function (composite measure).
Timepoint [1] 320229 0
At the end of each intensity of exercise (40% and 60% of Vo2peak, for both immersed and dry exercise).
Secondary outcome [2] 320291 0
Blood pressure will be measured using a Finomemter pro device and exported to software for analysis.
Timepoint [2] 320291 0
At the end of each intensity of exercise (40% and 60% of Vo2peak, for both immersed and dry exercise).
Secondary outcome [3] 320352 0
Heart rate will be measured by a heart rate monitor and by the finometer pro device
Timepoint [3] 320352 0
At the end of each intensity of exercise (40% and 60% of Vo2peak, for both immersed and dry exercise).

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
Sex
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)
This is a crossover study, so participants will take part in both water- and land-based exercise. The exercise that they take part in first will be randomly allocated by the participant selecting an opaque sealed envelope at their first session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
7 opaque envelopes will have water-exercise allocated as the first condition, 8 opaque envelopes will have land-exercise allocated as the first condition. The participants will select their allocation from these envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5181 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 5182 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 292771 0
University
Name [1] 292771 0
Curtin University
Country [1] 292771 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] 291505 0
None
Name [1] 291505 0
Address [1] 291505 0
Country [1] 291505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294264 0
Royal Perth Hospital Human Research Ethics Committee, EC00270
Ethics committee address [1] 294264 0
Ethics committee country [1] 294264 0
Australia
Date submitted for ethics approval [1] 294264 0
Approval date [1] 294264 0
04/12/2015
Ethics approval number [1] 294264 0
REG 15-165
Ethics committee name [2] 294265 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 294265 0
Ethics committee country [2] 294265 0
Australia
Date submitted for ethics approval [2] 294265 0
Approval date [2] 294265 0
15/12/2015
Ethics approval number [2] 294265 0
HR227/2015

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

Contacts
Principal investigator
Name 63106 0
A/Prof Andrew Maiorana
Address 63106 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country 63106 0
Australia
Phone 63106 0
+61892669225
Fax 63106 0
Email 63106 0
[email protected]
Contact person for public queries
Name 63107 0
Anna Scheer
Address 63107 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country 63107 0
Australia
Phone 63107 0
+61452236661
Fax 63107 0
Email 63107 0
[email protected]
Contact person for scientific queries
Name 63108 0
Anna Scheer
Address 63108 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country 63108 0
Australia
Phone 63108 0
+61452236661
Fax 63108 0
Email 63108 0
[email protected]

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: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



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.