Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000875707
Ethics application status
Approved
Date submitted
7/06/2022
Date registered
21/06/2022
Date last updated
28/04/2024
Date data sharing statement initially provided
21/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardiac rehabilitation in regional areas: developing a predictive model to determine exercise thresholds
Scientific title
Cardiac rehabilitation in regional areas: developing a predictive model to determine ventilatory thresholds from common field testing approaches
Secondary ID [1] 307250 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular health 326502 0
Condition category
Condition code
Cardiovascular 323765 323765 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a total of three (3) laboratory visits, separated by a minimum of 48 hours, to complete cardiorespiratory fitness assessment. The first two (2) visits are estimated to take approximately 60 minutes total with participants completing two (2) of four (4) randomly assigned field tests to assess cardiorespiratory fitness (two exercise tests in each session). The field tests include the 6 minute walk test, with participants required to walk as far as possible in 6 minutes, in a self-paced and standardized testing procedure. The incremental shuttle walk test, an externally paced walking test with increasing speed required to complete subsequent shuttle levels. The test is terminated when participants reach 85% of their age predicted heart rate maximum. The Astrand Rhyming submaximal cycle, a 6 minute cycle test designed to be completed at a sub-maximal intensity (less than 85% age-predicted heart rate maximum) with estimation of cardiorespiratory fitness based on work rate and heart rate response. Chester Step Test is an externally paced (metronome) step test with progression in intensity elicited every 2 minutes with an increase in speed. During all field test heart rate and visual analogue scales (dyspnea and rating of perceived exertion) will be recorded. The third laboratory visit (expected to take approximately 40 minutes) will involve an additional sub-maximal field test, the 30 second sit to stand. Participants are required to complete as many repetitions of unassisted sit and stand from a chair in 30 seconds. Finally participants will complete a symptom-limited cardiopulmonary exercise test (CPET) on a cycle ergometer, consisting of a ramp protocol and supervised by an Accredited Exercise Physiologist (AEP).
Intervention code [1] 323689 0
Lifestyle
Comparator / control treatment
Randomized cross-over design with no non-exercise control group. Field testing variables will be compared to symptom-limited cardiopulmonary exercise test (CPET). CPET is anticipated to take 15-20 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 331559 0
Assess validity of 6 minute walk test to determine VO2 peak and ventilatory anaerobic threshold in comparison to symptom-limited CPET conducted via ramp protocol on cycle ergometer
Timepoint [1] 331559 0
Baseline testing following recruitment and screening
Primary outcome [2] 331737 0
Assess validity of the incremental shuttle walk test to determine VO2 peak and ventilatory anaerobic threshold in comparison to symptom-limited CPET conducted via ramp protocol on cycle ergometer
Timepoint [2] 331737 0
Baseline testing following recruitment and screening
Primary outcome [3] 331738 0
Assess validity of the Astrand Rhyming cycle test to determine VO2 peak and ventilatory anaerobic threshold in comparison to symptom-limited CPET conducted via ramp protocol on cycle ergometer
Timepoint [3] 331738 0
Baseline testing following recruitment and screening
Secondary outcome [1] 410791 0
Assess validity of the Chester Step test to determine VO2 peak and ventilatory anaerobic threshold in comparison to symptom-limited CPET conducted via ramp protocol on cycle ergometer (primary outcome)
Timepoint [1] 410791 0
Baseline testing following recruitment and screening

Eligibility
Key inclusion criteria
Able to understand and respond to spoken English
Aged 18 years and older
Diagnosed with cardiovascular disease
Exiting out-patient cardiac rehabilitation program
Available to meet the time commitments
Physically able to complete testing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with heart failure or hypertrophic myopathy
Heart transplant participants
Unstable angina or myocardial infarction in the previous month

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation with the researcher responsible for participant screening blinded from testing order and group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization of testing sequence using computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A random model multiple linear regression was used to estimate sample size with H1 (0.69) based on previous outcomes (R2 = 0.71), H0 = 0.4, alpha of 0.05 and 95% power with 4 predictors (exercise time/distance/speed/repetitions, HR, RPE, body mass). Results indicate 70 participants will be required for adequate power. Ventilatory anaerobic threshold will be identified using ventilatory equivalents and V-slope method. Comparison between CPET and field based data include using paired samples t-test, level of agreement determined through Bland-Altman analysis and Pearson’s product-moment correlation coefficient r with 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/08/2022
Actual
18/09/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
12/07/2024
Actual
Sample size
Target
70
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22472 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [2] 22473 0
St John of God Hospital - Bendigo - Bendigo
Recruitment postcode(s) [1] 37746 0
3450 - Castlemaine
Recruitment postcode(s) [2] 37748 0
3463 - Maldon
Recruitment postcode(s) [3] 37706 0
3550 - Bendigo
Recruitment postcode(s) [4] 37747 0
3551 - Axedale

Funding & Sponsors
Funding source category [1] 311546 0
Charities/Societies/Foundations
Name [1] 311546 0
Holsworth Research Initiative
Country [1] 311546 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Edwards Road
Flora Hill, VIC, 3550
Country
Australia
Secondary sponsor category [1] 312961 0
Hospital
Name [1] 312961 0
Bendigo Health
Address [1] 312961 0
100 Bernard Street,
Bendigo, VIC, 3550
Country [1] 312961 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310999 0
Bendigo Health HREC
Ethics committee address [1] 310999 0
100 Bernard Street,
Bendigo, VIC, 3550
Ethics committee country [1] 310999 0
Australia
Date submitted for ethics approval [1] 310999 0
23/12/2021
Approval date [1] 310999 0
01/07/2022
Ethics approval number [1] 310999 0
81083

Summary
Brief summary
Exercise training has conventionally been considered a key factor in the multi-disciplinary approach to cardiac rehabilitation. However, recent systematic review and meta-analyses have reported a reduced effectiveness, particularly in regional areas with limited resources for exercising testing and delivery. More specifically, exercise training at a workload corresponding to the ventilatory anaerobic threshold has previously demonstrated significant improvements in cardiovascular health outcomes. However identifying such workloads requires specialized equipment including cardiopulmonary testing. Therefore, the proposed project is designed to identify submaximal field tests that can be used to prescribe exercise workloads at an individual’s ventilatory anaerobic threshold without the need for specialized equipment or expertise. It is hypothesized that the addition of participant heart rate and rating of perceived exertion will improve the accuracy of linear regression models based on field test protocols.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119642 0
Dr Blake Collins
Address 119642 0
La Trobe University
Edwards Road, Flora Hill
Bendigo, VIC, 3550
Country 119642 0
Australia
Phone 119642 0
+61 3 5444 7144
Fax 119642 0
Email 119642 0
b.collins@latrobe.edu.au
Contact person for public queries
Name 119643 0
Dr Blake Collins
Address 119643 0
La Trobe University
Edwards Road, Flora Hill
Bendigo, VIC, 3550
Country 119643 0
Australia
Phone 119643 0
+61 3 5444 7144
Fax 119643 0
Email 119643 0
b.collins@latrobe.edu.au
Contact person for scientific queries
Name 119644 0
Dr Blake Collins
Address 119644 0
La Trobe University
Edwards Road, Flora Hill
Bendigo, VIC, 3550
Country 119644 0
Australia
Phone 119644 0
+61 3 5444 7144
Fax 119644 0
Email 119644 0
b.collins@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable participant demographic data , pre- and post-data and training intervention data will be made available
When will data be available (start and end dates)?
Within 12-months of publication with no end-date
Available to whom?
Data will be made publicly available, members of the public and those within research communities will have access to both published and unpublished data which will not be identifiable.
Available for what types of analyses?
Any purpose. There is potential for follow-up research including re-analyses, systematic review and meta analyses however this will not be apparent until the data is collected and analyses
How or where can data be obtained?
Published on OPAL (La Trobe institutional repository): https://opal.latrobe.edu.au
Or made available to researchers upon reasonable request with contact directed to b.collins@latrobe.edu.au


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.