Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000511831
Ethics application status
Approved
Date submitted
30/04/2012
Date registered
14/05/2012
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
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
Nil
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

Intervention/exposure
Study type
Interventional
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.
OR
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
Rehabilitation
Comparator / control treatment
Usual care - clinic consultations, drug therapy
Control group
Active

Outcomes
Primary outcome [1] 287040 0
Mortality
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

Eligibility
Key inclusion criteria
Diagnosis of heart failure by echocardiography LVEF<40% any aetiology is accepted
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Two intervention groups vs control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2012
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
8/09/2024
Date of last data collection
Anticipated
8/09/2024
Actual
Sample size
Target
48
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 5257 0
2351

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287183 0
University of New England
Ethics committee address [1] 287183 0
Ethics committee country [1] 287183 0
Australia
Date submitted for ethics approval [1] 287183 0
07/05/2012
Approval date [1] 287183 0
31/05/2012
Ethics approval number [1] 287183 0
EC00143

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

Contacts
Principal investigator
Name 34122 0
Prof Neil Smart
Address 34122 0
University of New England
Armidale 2350 NSW
Country 34122 0
Australia
Phone 34122 0
+61 267734076
Fax 34122 0
Email 34122 0
nsmart2@une.edu.au
Contact person for public queries
Name 17369 0
Neil Smart
Address 17369 0
School of Science and Technology
University of New England
Armidale
NSW 2351
Country 17369 0
Australia
Phone 17369 0
+61 2 6773 4076
Fax 17369 0
+61 2 6773 5011
Email 17369 0
nsmart2@une.edu.au
Contact person for scientific queries
Name 8297 0
Neil Smart
Address 8297 0
School of Science and Technology
University of New England
Armidale
NSW 2351
Country 8297 0
Australia
Phone 8297 0
+61 2 6773 4076
Fax 8297 0
+61 2 6773 5011
Email 8297 0
nsmart2@une.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.