None listed
Conditions
Brief summary
This study will investigate the efficacy of a modified shorter duration (6-week) combined training-based cardiac rehabilitation program on functional capacity (physical and cardiac function) versus a standard-care longer duration (12-week) cardiac rehabilitation program. Combined training refers to an intervention combining progressive resistance training with aerobic training. Previous meta-analyses have shown that combined training is superior to aerobic training alone for enhancing physical function and that improvements in physical function are enhanced over a shorter duration in this population. However, whether the improvements in physical function are comparable between a shorter-duration (6-week) combined training cardiac rehabilitation program and a standard-care longer duration (12-week), aerobic-based, cardiac rehabilitation program is unknown. Project Aims: The overarching aim of this study is to compare the efficacy of a modified shorter duration cardiac rehabilitation program to a standard-care longer duration cardiac rehabilitation program on functional capacity (physical and cardiac function). It is expected that this study will provide important information on the efficacy of shorter duration combined training-based cardiac rehabilitation programs, potentially a superior model than standard-care longer duration cardiac rehabilitation. Research Design and Methods: Participants in this study will be recruited as outpatients, who have recently experienced an acute cardiac event, and have been referred to outpatient cardiac rehabilitation. Participants will undergo a standard nursing assessment from cardiac rehabilitation staff to be cleared for exercise before participating in this study. Participants will undergo baseline testing before being randomised to complete either a modified shorter duration (6-week) combined training cardiac rehabilitation program or the standard-care longer duration (12-week) cardiac rehabilitation program. Participants will undergo follow-up testing at 7-weeks, 13-weeks, 19-weeks and 31-weeks into the protocol. Tests include anthropometric measurements, aerobic capacity, muscle strength, heart rate variability, vascular compliance, body composition, quality of life, and physical activity monitoring. Adherence and compliance to cardiac rehabilitation will also be monitored. Within each group, changes in the aforementioned outcome measures will be analysed from baseline, before cardiac rehabilitation, to the conclusion of cardiac rehabilitation and at two extended follow-up time-points. Changes in the outcome measures will also be analysed between the two groups.
Interventions
This study will compare the efficacy of a modified twice per week for six weeks cardiac rehabilitation program (intervention) with a standard-care once per for twelve weeks cardiac rehabilitation program (control treatment) on outcomes of physical and cardiac function. The intervention is described here. Brief Name: Modified Shorter Duration Combined Training Cardiac Rehabilitation. Procedures and Number of Times: Participants in the intervention group will complete a cardiac rehabilitation program involving two sessions per week for six weeks. One session each week will involve one-hour of exercise including a 10-minute warm-up, 25 minutes of resistance training, 15 minutes of aerobic training and a 10-minute cool-down. The resistance training will involve a combination of the following exercises depending on the participant's medical treatment: leg extension/squat/sit-to-stand, chest press, shoulder press, upright row, leg curl, calf raise, hip extension, hip flexion, cable fly and latissimus dorsi pull-down. Participants will complete five of the aforementioned resistance training exercises initially for two sets of up to 10 repetitions at 60% of their predicted one-repetition maximum with two minute rest periods between sets. The prescription will be progressed via increases in repetitions per set and then intensity. The second session each week will be according to current cardiac rehabilitation practice, except participants will complete three resistance training exercises for 15 minutes in place of a dedicated walk. Cardiac disease related education will be provided to each participant according to standard care cardiac rehabilitation. Topics include heart disease and interventions/procedures, identifying and modifying risk factors, exercise and heart disease, self-management, medications, nutrition, emergency care, managing emotional responses to cardiac events, behaviour change, and community support services and cardiopulmonary resuscitation. Participants will attend one one-hour education session per week for six weeks. Given that standard care cardiac rehabilitation includes twelve education sessions, participants unable to attend a particular education session will be given a video-recorded copy of missed talks/discussions (where applicable) and/or physical hard-copies of applicable educational materials. Participants will be given advice to continue exercise at the conclusion of their cardiac rehabilitation program. Materials: Aerobic exercise will be completed as a training circuit (as per standard-care cardiac rehabilitation) using a combination of treadmills, bicycle ergometers, hand pedals, small hand weights, steps, and exercise balls as well as walking outside. In the intervention group, resistance training will be completed using cable machine weights, dumbbells and an exercise bench. Individual components of exercise prescription (frequency, intensity (load), duration, type) during cardiac rehabilitation will be recorded. Pulse oximeters will be used to monitor heart rate and oxygen saturation while the Borg 6-20 Rate of Perceived Exertion Scale will be used to evaluate the participant's rate of perceived exertion. Participants will have access to educational material via a combination of group talks/discussions, video-recorded talks/discussions and physical hard-copies of educational materials. Who: Cardiac rehabilitation sessions will be delivered by a combination of an Accredited Exercise Physiologist, experienced Cardiac Rehabilitation Coordinators/Nurses, Physiotherapists and Allied Health Assistants. Different education sessions will be provided by a Cardiac Rehabilitation Coordinator/Nurse, a Cardiac Rehabilitation Physiotherapist, an occupational therapist, a pharmacist, a dietitian, a paramedic, a social worker and Heartbeat volunteers. Mode of Delivery: The exercise sessions will be delivered face-to-face predominantly in a group setting. A rolling recruitment will be employed, therefore between 1-15 study participants are expected to be completing cardiac rehabilitation in any given session. Location: The intervention will be delivered in the outpatient cardiac rehabilitation clinic of a publicly funded hospital. Adherence: Adherence will be monitored by the Cardiac Rehabilitation Coordinators/Nurses, Physiotherapists and Accredited Exercise Physiologist involved with the study. The exercise sheets used in the study will be dated for every session that a participant attends cardiac rehabilitation, which will then be used to monitor attendance and compliance with the exercise prescription.
Sponsors
Study design
Eligibility
Inclusion criteria
Male and female patients that have recently experienced an acute cardiac event and are eligible for outpatient cardiac rehabilitation. This typically involves patients who have recently undergone coronary artery bypass graft surgery, a cardiac valve repair/replacement, atrial septal defect/ventricular septal defect and other cardiac surgeries, electrocardiogram detected cardiac events, percutaneous coronary interventions, or medical management of an acute cardiac condition.
Exclusion criteria
Key exclusion criteria include patients over the age of 80 years, children and pregnant women, patients with unstable cardiac disease, and significant cognitive impairments or understanding of the English language that limit understanding of the study.