None listed
Conditions
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.
Interventions
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 wi
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.
Sponsors
University of the Sunshine Coast (UniSC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed