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Trial registered on ANZCTR
Registration number
ACTRN12625000864426
Ethics application status
Approved
Date submitted
24/07/2025
Date registered
8/08/2025
Date last updated
8/08/2025
Date data sharing statement initially provided
8/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Can adding blood flow restriction exercise training to cardiac rehabilitation improve fitness and vascular health?
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Scientific title
The efficacy of blood flow restriction exercise training as an adjunct to a 6-week community-based cardiac rehabilitation program for improving exercise capacity and vascular health in adults with coronary artery disease.
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Secondary ID [1]
314744
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
coronary artery disease
338101
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Condition category
Condition code
Cardiovascular
334399
334399
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0
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Coronary heart disease
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Physical Medicine / Rehabilitation
334693
334693
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will attend a 6-week community-based cardiovascular rehabilitation (CR) program consisting of 2 supervised exercise sessions per week (i.e. 12 sessions in total). Each exercise session will be standardised, and participants will perform three bouts of aerobic exercise (cycling) that are separated by two upper and/or lower body resistance exercises. Participants will cycle with thigh pneumatic cuffs inflated to 50% limb occlusion pressure as determined at the start of each session with proprietary software onboard the pneumatic cuffs. Blood flow restriction cuffs will be inflated during the cycle exercise only. Duration of cycle bouts and the intensity of resistance exercises will be progressively increased over the 6-week program. During the intervention, participants will be instructed to complete at least three home-based walking sessions per week. In addition to the supervised and home-based sessions, participants will attend one education seminar.
Exercise sessions will be conducted in a community fitness centre at Vitality Village (Birtinya, QLD). Assessment visits will be conducted at the VasoActive research laboratory at the University of the Sunshine Coast (Sippy Downs Campus, QLD).
Supervised Exercise Sessions
Participants will attend a supervised exercise program twice weekly, scheduled at the same time of day, and separated by at least one day. All sessions will be administered in groups of up to six participants and supervised by an accredited exercise physiologist and experienced cardiac nurses. All sessions will be scheduled for 60-minutes and include a warm up, main session and a cool down. The main session will consist of three cycling bouts, each followed by two resistance exercises. Exercise parameters will be prescribed according to the FITT principle (frequency, intensity, time, type) in accordance with current exercise guidelines (Verdicchio et al., A Clinical Guide for Assessment and Prescription of Exercise and Physical Activity in Cardiac Rehabilitation. A CSANZ Position Statement. Heart, Lung and Circulation. 2023 Jul 27.) for patients attending cardiovascular rehabilitation.
Cycling intensity target will be set and maintained at 50% of each individual’s initial peak power output (PPO) throughout the intervention. Individual PPO will be determined based on sub-maximal graded cycle test performance at a pre-intervention assessment visit. Duration of cycling bouts will be three minutes in week one, progressed by one minute each week to eight minutes in week six.
Resistance exercises will include a combination of upper and lower body movements. All upper body exercises will begin at an intensity of 70% of one-repetition maximum, estimated from corresponding five-repetition maximum tests performed during a pre-intervention assessment visit. Initial intensity for all lower body exercises will be the participant’s body weight. Progression / regression of resistance exercises will be based on participant-reported rate of perceived exertion (RPE) for each exercise. No more than two exercises will be progressed in any session to avoid exercise overload. Resistance exercises will be cable row, bilateral heel raise, single arm cable press, sit to stand, bicep curl, and triceps extension.
Attendance will be monitored by attendance checklists.
Home-based walking sessions
In addition to the CR sessions, participants will be provided with home-based exercise guidelines and advice to complete at least three home-based walking sessions per week. Participant walking goals will be gradually progressed from 10 minutes of walking at the beginning of the program (i.e., Week 1) to 30 minutes at the end of the program (i.e., Week 6). Participants will be provided with an exercise logbook to record their home-based walking sessions. Logbooks will be reviewed by the study team each week.
Education Seminar
Participants will attend one cardiac-nurse-led education seminar (5.5 hours with breaks for morning tea and lunch) covering topics such as diet, medications, exercise, physical activities, mental well-being and lifestyle modifications for secondary prevention of cardiovascular disease (CVD). The seminar information will be based on the Australian dietary guidelines, the physical activity and exercise guidelines for Australians, the Australian clinical guidelines for the management of acute coronary syndromes, and the heart foundation guidelines. Seminars are delivered via powerpoint presentation with opportunities for group discussions and interactive activities. Seminars are conducted monthly at various locations, and participants will choose which seminar to attend during their time enrolled in the program. Attendance to the education seminars will be assessed using an attendance checklist.
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Intervention code [1]
331442
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Rehabilitation
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Comparator / control treatment
Participants randomised to the usual care group will receive the exact same exercise program as the intervention group, however they will cycle without pneumatic cuffs around their thighs. Participants in the usual care group will also be instructed to complete the home-based walking sessions and attend the education seminar.
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Control group
Active
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Outcomes
Primary outcome [1]
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Exercise capacity
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Assessment method [1]
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Maximum walking distance during the 6-minute walk test (6MWT).
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Timepoint [1]
342085
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Week 0 (baseline) and week 7 post-baseline (outcome)
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Primary outcome [2]
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Estimated cardiorespiratory fitness
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Assessment method [2]
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Estimated peak power output during sub-maximal graded cycle test will be used to calculate estimated cardiorespiratory fitness. Three minutes of light cycling with 10 Watts of resistance will form the warm-up period. After the warm-up period, each test stage will be 2 minutes in duration, starting at 20 Watts, with each stage increasing by 20 Watts. Participants will be instructed to maintain a constant pedalling rate of 50-70 revolutions per minute (RPM). The test may be ceased once the participant: 1) reaches 85% of age predicted HRmax (65% for individuals with beta-blockade therapy); 2) reaches systolic BP greater than or equal to 250 mmHg and/or diastolic BP greater than or equal to 115 mmHg; 3) exhibits clinical indications for stopping (e.g., chest discomfort, dyspnoea, light-headedness, or excessive fatigue); or 4) is unable to maintain a cadence above 50 RPM for more than 10-15s seconds. Participants will be instructed to continue light cycling, with 10 Watts of resistance applied, at the end of the test to allow for a controlled reduction of physiological variables to pre-test levels. Estimated peak power output (PPO) will be calculated by extrapolating the linear relationship between heart rate and workload across the final three completed stages of the graded sub-maximal cycle test. A linear regression equation will be fitted to this data and extended to the participant’s age predicted maximum heart rate (208 – 0.7 x age) to determine the corresponding predicted maximal workload (Tanaka et al., 2001). For participants on Beta-Blockers, a heart rate max formula (164 – 0.7 x age) will be used due to the attenuated HR response associated with this medication (Brawner et al., 2004).
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Timepoint [2]
342086
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Week 0 (baseline) and week 7 post-baseline (outcome)
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Secondary outcome [1]
449548
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Lower-limb muscular fitness
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Assessment method [1]
449548
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Completed number of repetitions during the 30-second sit-to-stand test.
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Timepoint [1]
449548
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Week 0 (baseline) and week 7 post-baseline (outcome)
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Secondary outcome [2]
449549
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Arterial stiffness.
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Assessment method [2]
449549
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Carotid-femoral artery pulse wave velocity (PWV). A hand-held tonometer probe be applied to the skin over the carotid artery to obtain carotid artery pulse waves, while a pressure cuff will be placed around the upper thigh to record femoral artery pulse waves. The distance from the carotid site above to the proximal edge of a thigh cuff over the femoral artery (midway between the hip and the knee) will be measured using a tape measure over the body area. The carotid and femoral pulse waves will be recorded simultaneously, and the femoral pulse wave requires the thigh cuff to be partially inflated. The pulse wave velocity will then be automatically calculated as the ratio of the distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. Pulse wave velocity will be determined by averaging duplicate measurements that fall within a 0.5 m/s range of each other.
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Timepoint [2]
449549
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Week 0 (baseline) and week 7 post-baseline (outcome).
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Secondary outcome [3]
449551
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Endothelial function.
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Assessment method [3]
449551
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Brachial artery flow-mediated dilatation (FMD). Brachial artery FMD will be measured in response to reactive hyperaemia in the forearm. A cuff will be placed around the forearm and inflated to 200 mmHg for 5 minutes. Upon release, change in brachial artery diameter and blood velocity will be recorded with a multi-frequency linear array probe, attached to a high resolution ultrasound machine.
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Timepoint [3]
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Week 0 (baseline) and week 7 post-baseline (outcome).
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Secondary outcome [4]
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Self-reported quality of life questionnaire.
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Assessment method [4]
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Health related quality of life questionnaire (SF-36)
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Timepoint [4]
449553
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Week 0 (baseline) and week 7 post-baseline (outcome).
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Secondary outcome [5]
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Arterial stiffness.
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Assessment method [5]
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Augmentation index (AIx). Brachial artery pulse waves will be obtained by partially inflating a cuff over the brachial artery using a SphygmoCor system. The device captures multiple pulse waveforms and applies a validated transfer function to derive central (aortic) pressure waveforms, from which AIx is calculated.
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Timepoint [5]
450226
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Week 0 (baseline) and week 7 post-baseline (outcome).
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Eligibility
Key inclusion criteria
1. Eligible for cardiac rehabilitation due to coronary artery disease (CAD), including post-myocardial infarction, post percutaneous coronary intervention (PCI), post coronary artery bypass grafting (CABG), post-acute coronary syndrome (ACS), and stable angina.
2. 18 years of age or older.
3. Sufficient ability to understand and communicate in English to complete informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Anyone deemed not eligible for cardiac rehabilitation by the program coordinator according to standard clinical and safety criteria.
2. Proximal thigh circumference < 33 cm or > 73 cm that prevents the proper fitting of blood flow restriction cuffs.
3. Current or recent (< 3 months) lower limb deep vein thrombosis (DVT) or clinical signs of DVT (e.g., unilateral leg swelling, pain, or tenderness).
4. Known diagnosis of clotting disorders that elevate the risk of venous thromboembolism (e.g., antiphospholipid syndrome, thrombophilia, anti-thrombin deficiency).
5. Diagnosis of deep venous incompetence in either lower limb.
6. History of femoral or popliteal artery stents or grafts in either thigh.
7. Known arterial aneurysm in either lower limb.
8. Current or recent (<3 months) presence of lower limb skin ulcers or gangrene.
9. Osteo-arthritis or musculoskeletal injuries that limit the ability to walk unaided or to perform the required testing measurements and exercise.
10. Are currently participating, or have participated within the past 12 weeks, in a structured supervised exercise program.
11. Pregnant or intending to become pregnant during the study period.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be ensured using a centralised computer allocation service (SealedEnvelope.com).
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be generated using a secure, independent web-based randomisation system (SealedEnvelope.com). Randomisation will be in a 1:1 ratio and randomisation blocks of 2-6 participants will be used to ensure equal group numbers throughout the recruitment and enrolment period.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size estimation will be based on a large effect size of 0.846. Setting the alpha level at p=0.05 and statistical power at >0.80, 18 participants will be required per group. To allow for a 10% dropout rate, 20 participants will be recruited per group, resulting in a total sample size of 40.
The primary analysis will be conducted on a per-protocol basis and include participants that attend at least 9 community-based CR exercise sessions (i.e., 70% adherence), and complete at least 70% of their total home-based walking sessions (i.e. 13 sessions overall) during the 6-week intervention period. The number of supervised exercise sessions completed, and the total number of supervised and home-based sessions completed, will be included in analysis as covariates.
All data in this study will be presented as the mean ± standard deviation. All functional test data, hemodynamic, and vascular measures will be analysed using the mixed model analysis of variance (ANOVA) for relevant between factor for Group (BFR; non-BFR) and within factors for Time (baseline; six weeks). Percentage change data for each outcome measure will be compared using two-tailed T tests. Fisher’s least significant difference will be used for post-hoc pairwise comparisons. Statistical significance will be set at p < 0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
18/08/2025
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Actual
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Date of last participant enrolment
Anticipated
6/10/2025
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
28237
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Sunshine Coast University Hospital - Birtinya
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Recruitment postcode(s) [1]
44448
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4575 - Birtinya
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Funding & Sponsors
Funding source category [1]
319297
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University
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Name [1]
319297
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University of the Sunshine Coast (UniSC)
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Address [1]
319297
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Country [1]
319297
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Australia
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Primary sponsor type
University
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Name
University of the Sunshine Coast (UniSC)
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Address
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Country
Australia
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Secondary sponsor category [1]
321771
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None
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Name [1]
321771
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Address [1]
321771
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Country [1]
321771
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Other collaborator category [1]
283582
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Hospital
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Name [1]
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Sunshine Coast University Hospital
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Address [1]
283582
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Country [1]
283582
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317875
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Metro North Health Human Research Ethics Committee
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Ethics committee address [1]
317875
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https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
317875
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Australia
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Date submitted for ethics approval [1]
317875
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20/05/2025
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Approval date [1]
317875
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21/07/2025
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Ethics approval number [1]
317875
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HREC/2025/MNH/118062
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Summary
Brief summary
The aim of this study is to assess the efficacy of blood flow restriction exercise training during a 6-week community-based cardiac rehabilitation exercise program. Specifically, in individuals with coronary artery disease who are eligible for cardiac rehabilitation, this study will assess whether adding blood flow restriction (via inflating pneumatic cuffs on the proximal portion of the legs) during aerobic exercise portions of the rehabilitation program leads to greater improvements in exercise capacity, 6 minute walking distance and markers of vascular health, when compared with the routine aerobic exercise undertaken by cardiac rehabilitation participants (no cuffs). Participants will be randomised to either the blood flow restriction exercise group or the routine rehabilitation exercise group for the duration of the 6-week (12 session) program. Participants will also attend a total of 4 assessment visits; 2 baseline (week 0) measurement visits (the first of which includes screening to assess eligibility) and 2 visits post-program (week 7 post-baseline) to compare changes between groups and over time.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Chris Askew
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Address
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School of Health, University of the Sunshine Coast, Sippy Downs Drive, Sippy Downs, QLD, 4556
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Country
142430
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Australia
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Phone
142430
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+61 412 332 987
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Fax
142430
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Email
142430
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[email protected]
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Contact person for public queries
Name
142431
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Andrew Kwintowski
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Address
142431
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School of Health, University of the Sunshine Coast, Sippy Downs Drive, Sippy Downs, QLD, 4556
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Country
142431
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Australia
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Phone
142431
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+61 412 381 663
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Fax
142431
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Email
142431
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[email protected]
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Contact person for scientific queries
Name
142432
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Chris Askew
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Address
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School of Health, University of the Sunshine Coast, Sippy Downs Drive, Sippy Downs, QLD, 4556
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Country
142432
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Australia
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Phone
142432
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+61 412 332 987
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Fax
142432
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Email
142432
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Only investigators and study staff involved in the collection and analysis of the data will have access to (de-identifiable) participant data. Participant data will not be shared with other research groups.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
[email protected]
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.
Download to PDF