Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000164796
Ethics application status
Approved
Date submitted
7/02/2013
Date registered
11/02/2013
Date last updated
17/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Peak Heart Rate during Upright Treadmill and Supine Cycling.
Scientific title
In healthy volunteers what is the heart rate response to supine bicycle exercise compared to upright treadmill exercise.
Secondary ID [1] 281915 0
nil known
Universal Trial Number (UTN)
U1111-1138-9650
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 288313 0
Condition category
Condition code
Cardiovascular 288668 288668 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will initially undergo an upright treadmill exercise assessment. A modified protocol will be used consisting of a 2 minute warm-up period at slow walking pace, followed by ramped increase of both treadmill speed and inclination to reach maximum age predicted heart rate in 5-8 minutes. Once maximum heart rate is reached participants will step to the side of the treadmill for 15 seconds rest, before starting again for another 30 seconds. This is repeated 8 times to simulate the pauses needed during the MRI assessment.
During a second clinic session 2-14 days later, participants will be placed in an MRI and undergo a resting scan, followed by a scan during exercise where they will be asked to pedal in the supine position while still in the scan position. The exercise protocol begins with a 2 minute warm-up period pedalling at 60-90 rpm with no resistance. The resistance is then increased to achieve maximum exercise in 5-8 minutes. Once maximum exertion is reached participants stop pedalling for 10 seconds for MRI image acquisition and then begin pedalling again for a further 30 seconds before stopping again for another acquisition. This is repeated 8 times to acquire all required images.
Intervention code [1] 286480 0
Diagnosis / Prognosis
Intervention code [2] 286493 0
Early detection / Screening
Comparator / control treatment
The control method for this study exercises participants on an upright treadmill using a modified protocol will be used consisting of a 2 minute warm-up period at slow walking pace, followed by ramped increase of both treadmill speed and inclination to reach maximum age predicted heart rate in 5-8 minutes.
Control group
Active

Outcomes
Primary outcome [1] 288815 0
The primary outcome is to achieve a heart rate response during supine bicycle exercise increases to 80% of that obtained during upright treadmill. The heart rate is monitored by ECG during both treadmill and MRI and pulse-ox as a secondary measurement during MRI.
Timepoint [1] 288815 0
Heart rate is recorded throughout each test and comparisons made at peak exercise capacity.
Secondary outcome [1] 301058 0
acquisition of ventricular function using MRI during supine exercise
Timepoint [1] 301058 0
MRI image acquisition occurs within seconds of reaching the exercise target as participants are pedalling while in the scan position.

Eligibility
Key inclusion criteria
healthy controls aged 20-75
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, contraindication to MRI, atrial fibrillation, physical limitations preventing treadmill or cycle exercise, known cardiovascular disease - especially CAD, hypertensive (treated or untreated) - resting blood pressure (supine) above 160/100 mmHg.

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2013
Actual
7/03/2013
Date of last participant enrolment
Anticipated
Actual
10/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 4856 0
New Zealand
State/province [1] 4856 0
Auckland

Funding & Sponsors
Funding source category [1] 286704 0
University
Name [1] 286704 0
University of Auckland
Country [1] 286704 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Faculty of Medical and Health Sciences
85 Park Rd Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 285475 0
None
Name [1] 285475 0
None
Address [1] 285475 0
N/A
Country [1] 285475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288770 0
Health and Disability Ethics Committees
Ethics committee address [1] 288770 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 288770 0
New Zealand
Date submitted for ethics approval [1] 288770 0
11/02/2013
Approval date [1] 288770 0
21/02/2013
Ethics approval number [1] 288770 0

Summary
Brief summary
This study is a pilot to measure the maximum heart rate possible cycling in the supine position to gain experience to plan future cardiac magnetic resonance imaging (MRI) studies using exercise stress for the assessment of patients with coronary artery disease (CAD). Typical exercise stress tests are often conducted walking upright using treadmills. Imaging at peak heart rates are limited by delays as participants are moved from the treadmill into the image position. Supine exercise removes this delay. However it is not well known what heart rates are possible in this position as fewer muscle groups are engaged. In this study heart rate data from the supine position will be compared against that obtained by treadmill for each participant and the hearts function will be assessed using MRI. Ventricular function and aortic pulse wave velocity (PWV) and distensibilty measurements will be assessed, both at rest and peak heart rates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37694 0
A/Prof Alistair Young
Address 37694 0
University of Auckland
Faculty of Medical and Healthy Sciences
Private Bag 92019
Auckland 1023
Country 37694 0
New Zealand
Phone 37694 0
+64 9 373 7599
Fax 37694 0
Email 37694 0
a.young@auckland.ac.nz
Contact person for public queries
Name 37695 0
Mr Paul Roberts
Address 37695 0
Auckland Bioengineering Institute
The University of Auckland
Private Bag 92019
Auckland 1142
Country 37695 0
New Zealand
Phone 37695 0
+64 9 373 7599
Fax 37695 0
Email 37695 0
prob114@aucklanduni.ac.nz
Contact person for scientific queries
Name 37696 0
Mr Paul Roberts
Address 37696 0
Auckland Bioengineering Institute
The University of Auckland
Private Bag 92019
Auckland 1142
Country 37696 0
New Zealand
Phone 37696 0
+64 9 373 7599
Fax 37696 0
Email 37696 0
prob114@aucklanduni.ac.nz

No information has been provided regarding IPD availability


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
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