Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000935538
Ethics application status
Approved
Date submitted
28/08/2015
Date registered
8/09/2015
Date last updated
27/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
12 weeks of single-leg cycling in individuals with coronary artery disease
Scientific title
In individuals with stable coronary artery disease, does single-leg cycling improve functional capacity greater than double-leg cycling?
Secondary ID [1] 286923 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 295347 0
Condition category
Condition code
Cardiovascular 295615 295615 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 295616 295616 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with stable heart disease will be randomised to one of two exercise groups involving 12 weeks of different forms of cycling. One group will undertake single-leg high intensity interval cycle training and the second group will undertake double-leg high intensity interval cycle training.

All exercise intensities will be prescribed according to a predetermined level of perceived exertion, using the Borg 6-20 rating of perceived exertion (RPE) scale, which is associated with a desired percent of aerobic capacity (VO2peak). Each session will begin and end with a 5 minute double-leg cycling based warm-up (intensity; RPE 11-13, 40-60% VO2peak) and cool down (intensity; RPE 8-10, 20-40% VO2peak), followed by a 20 minute resistance circuit, as is standard practice in cardiac rehabilitation programs. During the double-leg high intensity interval sessions, the participant will complete ten 30 second double-leg efforts at an RPE 15-17 (60-85% VO2peak) with each effort separated by 60 seconds of passive rest (RPE 6; <20% VO2peak). During the single-leg high intensity interval sessions, participants will complete ten 30 second single-leg efforts at an RPE of 15-17 with each effort separated by 60 seconds of passive rest (RPE 6). At the completion of the first ten efforts, a short break will be provided (~5 minutes) prior to the participant completing another ten efforts with the opposite leg.

3 sessions per week will be prescribed and monitored by Miss Nicole Gordon, an ESSA Accredited Exercise Physiologist. Program adherence will be monitored through exercise logs.
Intervention code [1] 292113 0
Rehabilitation
Intervention code [2] 292114 0
Treatment: Other
Intervention code [3] 292115 0
Lifestyle
Comparator / control treatment
The double-leg high intensity group will be used as the control group upon which the focus of the study, single-leg high intensity cycling, will be compared against.
Control group
Active

Outcomes
Primary outcome [1] 295351 0
Functional capacity will be assessed during a graded exercise test to volitional exhaustion on a cycle ergometer for determine of maximal aerobic capacity.
Timepoint [1] 295351 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Primary outcome [2] 296005 0
Activities of daily living will be assessed by the five times sit-to-stand, 30 seconds sit-to-stand and the timed up and go tests.
Timepoint [2] 296005 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [1] 317061 0
Endothelial function will be assessed by noninvasive ultrasound of an artery in the arm (brachial artery) to evaluate flow-mediated dilation and glyceryl trinitrate-mediated dilation.
Timepoint [1] 317061 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [2] 317062 0
Heart structure will be assessed by cardiac MRI.
Timepoint [2] 317062 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [3] 317063 0
Body composition will be assessed by waist and hip circumference as well as a dual energy xray absorptiometry (DEXA) scan for determination of body fat, muscle and bone mineral content.
Timepoint [3] 317063 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [4] 317064 0
Leg strength will be assessed by a series of isokinetic and isometric tests of the quadriceps muscle on a HumacNorm Dynamometer.
Timepoint [4] 317064 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [5] 317065 0
Cardiovascular risk factor status will be assessed as a composite outcome by a single fasting blood sample analysing cholesterol profile, insulin sensitivity and markers of inflammation (CRP and fibrinogen).
Timepoint [5] 317065 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [6] 317073 0
General quality of life will be assessed by the Short Form 12 questionnaire.
Timepoint [6] 317073 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [7] 317213 0
Heart function will be assessed by impedance cardiography (PhysioFlow) during the graded exercise test.
Timepoint [7] 317213 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [8] 317214 0
Physical activity levels will be assessed by the International Physical Activity Questionnaire.
Timepoint [8] 317214 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [9] 317215 0
Psychosocial status will be assessed by the Cardiac Depression Scale.
Timepoint [9] 317215 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.
Secondary outcome [10] 317216 0
Health-related quality of life will be assessed by the MacNew Health-related Quality of Life questionnaire.
Timepoint [10] 317216 0
Outcome will be assessed at baseline and following the 12 week exercise intervention.

Eligibility
Key inclusion criteria
Individuals with established coronary artery disease assessed by angiography, a history of an acute coronary syndrome, or elective percutaneous coronary intervention or coronary artery bypass grafting surgery.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals less than 6 months after an acute cardiac event or surgery, signs or symptoms of myocardial ischaemia at rest, or in response to maximal exercise testing, left ventricular ejection fraction < /= 45%, moderate to severe aortic stenosis, a history of complex ventricular arrhythmias, uncontrolled diabetes mellitus or hypertension, recent medication change (<2 weeks), or orthopaedic or neurological disorders.

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)
Randomisation by computer, and then placed into sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The power analysis (a = 0.05, power = 0.8, calculated total sample size = 58) was completed using a difference in peak aerobic capacity of 2.5 +/- 3.3 mL/kg/min following 8 weeks of single-leg high intensity cycling in patients with chronic obstructive pulmonary disease [Bjorgen 2009]. An additional 2 participants will be recruited to account for dropouts, giving a total target sample size of 60 participants.

All analyses will be conducted on an intention-to-treat basis. Linear mixed modelling will be used to assess differences between interventions for physiological, functional and psychosocial outcomes. Significant main effects or interactions will be analysed using Tukey’s post hoc analysis. Statistical analysis will be performed using SPSS v21.0 data analysis software (SPSS, Chicago, IL) with significance set at p < 0.05.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3931 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 3932 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 291486 0
University
Name [1] 291486 0
School of Psychology and Exercise Science, Murdoch University
Country [1] 291486 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 290594 0
Hospital
Name [1] 290594 0
Fiona Stanley Hospital
Address [1] 290594 0
102-118 Murdoch Dr
Murdoch WA 6150
Country [1] 290594 0
Australia
Secondary sponsor category [2] 290595 0
Hospital
Name [2] 290595 0
Royal Perth Hospital
Address [2] 290595 0
197 Wellington St
Perth WA 6000
Country [2] 290595 0
Australia
Other collaborator category [1] 278603 0
University
Name [1] 278603 0
Curtin University
Address [1] 278603 0
Kent St
Bentley WA 6102
Country [1] 278603 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293029 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 293029 0
Ethics committee country [1] 293029 0
Australia
Date submitted for ethics approval [1] 293029 0
Approval date [1] 293029 0
27/01/2015
Ethics approval number [1] 293029 0
REG 14-159

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

Contacts
Principal investigator
Name 58142 0
Miss Nicole Gordon
Address 58142 0
REF3.001, Refectory building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 58142 0
Australia
Phone 58142 0
+61 448 098 227
Fax 58142 0
Email 58142 0
[email protected]
Contact person for public queries
Name 58143 0
Nicole Gordon
Address 58143 0
REF3.001, Refectory building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 58143 0
Australia
Phone 58143 0
+61 448 098 227
Fax 58143 0
Email 58143 0
[email protected]
Contact person for scientific queries
Name 58144 0
Nicole Gordon
Address 58144 0
REF3.001, Refectory building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 58144 0
Australia
Phone 58144 0
+61 448 098 227
Fax 58144 0
Email 58144 0
[email protected]

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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