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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical outcomes and cardiovascular responses to High Intensity Interval Training versus Moderate Intensity Continuous Training in Heart Failure Patients:
A randomized, controlled trial.
Scientific title
Clinical outcomes and cardiovascular responses to high intensity interval exercise training versus moderate intensity continuous exercise training compared to usual care in patients with moderate to severe heart failure
Secondary ID [1] 280420 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systolic Heart Failure 286388 0
Condition category
Condition code
Cardiovascular 286638 286638 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 286716 286716 0 0
Other physical medicine / rehabilitation

Study type
Description of intervention(s) / exposure
1. High intensity interval stationary cycle exercise training at 95% of maximum exercise capacity for 15-20 minutes (although patients will be required to be rpesent for 45-50 minutes to assess and prepare then and conduct warm-up/cool-down)them, thrice weekly for an overall duration of the training program of 6 months.
This gorup will exercise for 4 minutes and rest for 1 minute and then repeat this exercise;rest pattern 3-4 more times. Interval exercise with be preceded by a 5-10 minute warm-up and 5-10 minute cool down.
2. Moderate intensity (70% maximum) continuous stationary cycling exercise training for 45-50 minutes, thrice weekly for an overall duration of the training program of 6 months.
Intervention code [1] 284775 0
Comparator / control treatment
Usual care - clinic consultations, drug therapy
Control group

Primary outcome [1] 287040 0
Timepoint [1] 287040 0
6 and 12 months
Secondary outcome [1] 297258 0
Peak VO2 (Cardiorespiratory fitness) will be assessed by expired gas analysis during staionary cycling using a 10W per min increment until volitional exhaustion or medical reason to terminate the test is reached.
Timepoint [1] 297258 0
0,1, 2, 3, 4, 5, 6, 12 months
Secondary outcome [2] 297392 0
Heart Function by echocardiography (pre and immediately post exercise testing)
Timepoint [2] 297392 0
0,3,6,12 months
Secondary outcome [3] 297393 0
Brain Natriuertic Peptide and ST-2 (both assesed by venipuncture, plasma separation and commercial assay)
Timepoint [3] 297393 0
0,3,6,12 months
Secondary outcome [4] 297394 0
Quality of life (Minnesota Living with Heart Failure Questionnaire)
Timepoint [4] 297394 0
0,1, 2, 3, 4, 5, 6, 12 months

Key inclusion criteria
Diagnosis of heart failure by echocardiography LVEF<40% any aetiology is accepted
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Myocardial infarction within prior 12 months.
Change of medical therapy in the 3 months prior to study entry.
Unstable angina
Resting systolic blood pressure > 200 mm Hg, or diastolic blood pressure > 110 mm Hg,
Systemic illness
Fever and critical aortic stenosis (peak systolic pressure gradient > 50 mm Hg with an aortic valve orifice area > 0.75 cm2 in average size adult).
Uncontrolled atrial or ventricular arrhythmias such as uncontrolled sinus tachycardia (> 120 beats.min-1), 3rd degree AV block, active pericarditis or myocarditis, recent embolism, thrombophlebitis and resting ST segment displacement (> 2 mm).
Uncontrolled diabetes (resting blood glucose of > 400 mg/dL)
Severe orthopedic conditions that would prohibit exercise
Other metabolic conditions such as acute thyroiditis, hypokalemia or hyperkalemia and hypovolemia.
dementia; any systemic disease limiting exercise; inability to participate in a prospective study for any logistic reason, chronic inflammatory disease

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Investigator X (not involved in testing or intervention) will generate using Excel a random number sequence. Upon subjects completing informed consent and baseline testing to ensure they meet inclusion criteria, investigator X will be asked to provide a group allocation based on the random number selected for the subject.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization stratifying for age, gender, peak VO2, LVEF
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Two intervention groups vs control
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5257 0

Funding & Sponsors
Funding source category [1] 285176 0
Name [1] 285176 0
University of New England
Address [1] 285176 0
School of Science and Technology
NSW 2351
Country [1] 285176 0
Primary sponsor type
University of New England
School of Science and Technology
NSW 2351
Secondary sponsor category [1] 284044 0
Name [1] 284044 0
Neil Smart
Address [1] 284044 0
University of New England
School of Science and Technology
NSW 2351
Country [1] 284044 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287183 0
University of New England
Ethics committee address [1] 287183 0
Research Services
NSW 2351
Ethics committee country [1] 287183 0
Date submitted for ethics approval [1] 287183 0
Approval date [1] 287183 0
Ethics approval number [1] 287183 0

Brief summary
This study aims to build on the work by Wisoff 2007 published in circulation that showed superior benefits of high intensity interval training over moderate intensity continuous training in heart failure patients. It is hoped that with a larger sample size and longer follow up and intervention period the primary outcome, mortality will be significantly improved.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34122 0
Address 34122 0
Country 34122 0
Phone 34122 0
Fax 34122 0
Email 34122 0
Contact person for public queries
Name 17369 0
Neil Smart
Address 17369 0
School of Science and Technology
University of New England
NSW 2351
Country 17369 0
Phone 17369 0
+61 2 6773 4076
Fax 17369 0
+61 2 6773 5011
Email 17369 0
Contact person for scientific queries
Name 8297 0
Neil Smart
Address 8297 0
School of Science and Technology
University of New England
NSW 2351
Country 8297 0
Phone 8297 0
+61 2 6773 4076
Fax 8297 0
+61 2 6773 5011
Email 8297 0

No information has been provided regarding IPD availability
Summary results
No Results