Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001338459
Ethics application status
Approved
Date submitted
6/09/2016
Date registered
26/09/2016
Date last updated
10/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
High Intensity Aerobic Interval and Training within Supervised Cardiac Rehabilitation
Scientific title
Functional Capacity and Strength changes using High Intensity Aerobic Interval Training within Supervised Cardiac Rehabilitation compared to usual care.
Secondary ID [1] 287090 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
 295602 0
Condition category
Condition code
Cardiovascular 295879 295879 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 295880 295880 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised cardiac rehabilitation exercise program consisting of high intensity interval aerobic 40 mins performed twice weekly for 6 weeks. These will be held at the Robina Health Precinct gymnasium and will be integrated within the cardiac rehabilitation class. The classes will be supervised by a physiotherapist or Exercise Physiologist with Bachelor degrees or Masters Degree and a cardiac nurse. This will consist of a 5 min warm up, 2x4 mins on a treadmill or cycle ergometer at 85-90% VO2peak, interspersed with 2 mins at 50-60% VO2peak, and 10 minute cool down.
Intervention code [1] 292351 0
Treatment: Other
Intervention code [2] 292352 0
Rehabilitation
Intervention code [3] 292353 0
Lifestyle
Comparator / control treatment
Supervised cardiac rehabilitation exercise program consisting of moderate continuous aerobic at 50-70% VO2max and resistance training for 60 mins performed twice weekly for 6 weeks at the Robina Health Precinct in small group settings. The resistance training comprises 10 mins of light resistance training. 1-2 sets of 12 reps including leg press or wall squats, bicep curls, wall push ups, heel raises and step ups.
Control group
Active

Outcomes
Primary outcome [1] 295584 0
Aerobic Capacity Via VO2 max testing on treadmill and six minute walk test
Timepoint [1] 295584 0
VO2max test and six minute walk test will be performed before intervention and at 6 weeks post enrolment.
Primary outcome [2] 295585 0
Strength tests- grip strength and time for 5xsit to stand test
Timepoint [2] 295585 0
Before intervention and at 6 weeks post enrolment
Primary outcome [3] 295586 0
Quality of Life - SF36
Timepoint [3] 295586 0
Before intervention and at 6 weeks post enrolment
Secondary outcome [1] 315899 0
Exercise session adherence and compliance- assessed by accessing attendance records and completion of program records.
Timepoint [1] 315899 0
6 weeks
Secondary outcome [2] 327579 0
healthcare utilisation costs from analysis of costs required and budgetary documents
Timepoint [2] 327579 0
over the 6 week intervention
Secondary outcome [3] 327580 0
readmission rates from accessing Public Health data from Gold Coast University Hospital records
Timepoint [3] 327580 0
6 months post intervention
Secondary outcome [4] 327581 0
length of hospital stay from Gold Coast University Hospital Public Health data
Timepoint [4] 327581 0
6 months post intervention
Secondary outcome [5] 327582 0
return to work from cardiac rehabilitation records or follow up phone call to patient
Timepoint [5] 327582 0
Throughout study up to 6 months post intervention
Secondary outcome [6] 327618 0
Tanita body fat scale - percent body fat, muscle mass
Timepoint [6] 327618 0
Pre and post 6 week gymnasium intervention
Secondary outcome [7] 327762 0
Program uptake from analysis of number of referrals to number of participants
Timepoint [7] 327762 0
at 6 months
Secondary outcome [8] 327904 0
Patient satisfaction will be assessed by collating results from a survey specifically designed for this study.
Timepoint [8] 327904 0
This will be given preadmission and at 6 weeks
Secondary outcome [9] 327930 0
Barriers to enrolment into cardiac rehabilitation from a patient perspective will be assessed by collating results from a survey specifically designed for this study.
Timepoint [9] 327930 0
This will be given preadmission and at 6 weeks

Eligibility
Key inclusion criteria
All patients eligible to attend the Gold Coast University Cardiac Rehabilitation Program. Patients 2 weeks post non-st elevation myocardial infarction (NSTEMI), 3-4 weeks post st elevation myocardial infarction (STEMI), 2 weeks post percutaneous intervention and 4 weeks post coronary artery bypass surgery, who have been cleared for high intensity interval training via VO2 max treadmill test with ECG monitoring are eligible.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute congestive heart failure, unstable haemodynamics, unable to follow instructions, ischaemia at rest or during VO2max, uncontrolled rhythm disturbances, unstable blood glucose levels, unstable angina, pulmonary hypertension, acute atrial fibrillation, third degree heart block without pacemaker, severe aortic stenosis, recent embolism or stroke, terminal illness, recent surgery, pacemaker/ICD, heart transplant, severe febrile illness, psychological or musculoskeletal injury that precludes the use of exercise and resistance training equipment.

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)
Any eligible patient will be offered participation in the trial and undergo a VO2max test. Once medically cleared, they will be de-identified and randomly (computer generated) allocated to either the high intensity or control group by central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer software system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The staff performing the VO2 max testing will be blinded to the subject's group allocation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Clinical and treatment related outcomes include both categorical and continuous measures. Appropriate statistical testing will be conducted to identify significant differences between treatment and control groups at 6 wks and 6 months post intervention (for readmission rates). Where there is significant heterogeneity among individual’s outcome measures, mixed effects statistical models will be used incorporating baseline, 6 week and 6 month data. The sample size was calculated using the mean number from 10 RCTs identified as comparing HIIT and MCT in the cardiac population (n=65.6) as well as using a sample size calculator with 95% certainty, confidence interval of 12.19 and population of 1500 (number of admissions of eligible patients to cardiac rehabilitation/year within the Gold Coast Health Service District. (n=62). A further calculator (G power) was also used. Standard deviation was assumed to be 2 with a power of 0.9 and significance level of 0.05 with effect size of 1. The difference between groups was assumed to be 2. The sample size calculated was 46. As we are trialling a different exercise dosage to the literature our sample size was chosen as 62.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2017
Actual
Date of last participant enrolment
Anticipated
21/03/2018
Actual
Date of last data collection
Anticipated
1/05/2018
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4058 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 9986 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 291664 0
University
Name [1] 291664 0
Bond University
Country [1] 291664 0
Australia
Primary sponsor type
Individual
Name
Assistant Professor Amanda (Mandy) Hannan
Address
Bond Institute Health and Sport
2 Promethean Way
Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 290338 0
Individual
Name [1] 290338 0
Professor Wayne Hing
Address [1] 290338 0
Bond Institute Health and Sport
2 Promethean Way
Robina QLD 4226
Country [1] 290338 0
Australia
Other collaborator category [1] 278529 0
Individual
Name [1] 278529 0
Professor Rohan Jayasinghe
Address [1] 278529 0
Director Cardiology
Gold Coast University Hospital
University Dr
Southport QLD 4215
Country [1] 278529 0
Australia
Other collaborator category [2] 278530 0
Other
Name [2] 278530 0
Robina Precinct, Gold Coast University Cardiac Rehabilitation Program
Address [2] 278530 0
Robina Precinct
2 Campus Crescent
Robina QLD 4226
Country [2] 278530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293191 0
Gold Coast Human Research Ethics Committee
Ethics committee address [1] 293191 0
Ethics committee country [1] 293191 0
Australia
Date submitted for ethics approval [1] 293191 0
Approval date [1] 293191 0
21/10/2014
Ethics approval number [1] 293191 0
HREC 14/QGC/148
Ethics committee name [2] 293192 0
Bond University Human Research Ethics Committee
Ethics committee address [2] 293192 0
Ethics committee country [2] 293192 0
Australia
Date submitted for ethics approval [2] 293192 0
Approval date [2] 293192 0
12/11/2014
Ethics approval number [2] 293192 0
RO1916
Ethics committee name [3] 293193 0
Mental Health and Integrated Care Ethics Committee
Ethics committee address [3] 293193 0
Ethics committee country [3] 293193 0
Australia
Date submitted for ethics approval [3] 293193 0
Approval date [3] 293193 0
22/05/2015
Ethics approval number [3] 293193 0
HREC 14/QGC/148

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

Contacts
Principal investigator
Name 58790 0
Mrs Amanda (Mandy) Hannan
Address 58790 0
Bond Institute of Health and Sport
Faculty of Health Sciences and Medicine
2 Promethean Way
Robina QLD 4226
Country 58790 0
Australia
Phone 58790 0
+61755954161
Fax 58790 0
Email 58790 0
[email protected]
Contact person for public queries
Name 58791 0
Amanda (Mandy) Hannan
Address 58791 0
Bond Institute of Health and Sport
Faculty of Health Sciences and Medicine
2 Promethean Way
Robina QLD 4226
Country 58791 0
Australia
Phone 58791 0
+61755954161
Fax 58791 0
Email 58791 0
[email protected]
Contact person for scientific queries
Name 58792 0
Amanda (Mandy) Hannan
Address 58792 0
Bond Institute of Health and Sport
Faculty of Health Sciences and Medicine
2 Promethean Way
Robina QLD 4226
Country 58792 0
Australia
Phone 58792 0
+61755954161
Fax 58792 0
Email 58792 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
No additional documents have been identified.