None listed
Conditions
Brief summary
Patients with atrial fibrillation may have their treatment path altered due to frailty, yet we do not have guidelines in place to manage frailty if it is diagnosed. The project aims to recruit patients with atrial fibrillation >60 years old who also have some level of frailty and can still participate in exercise. These patients will undergo a multidomain assessment battery establishing multiple aspects of their biopsychosocial health with the primary focus being on physical frailty. Patients will then be randomised to either continuing their medical care as usual or adding an exercise intervention to their treatment for 6-months. At the end of the intervention and 6-montss following (12-months from baseline) patients will undergo the same assessment battery as baseline to determine if exercise is effective in managing frailty in patients with atrial fibrillation.
Interventions
The exercise intervention has been designed with the extensive contribution of people with lived experience of AF during a combination of small and large group consumer engagement and design sessions. Patients who contributed to the co-design process advised that the following considerations are important. The AF-FIT intervention will be delivered by clinical exercise physiologists over a 26-weeek period in a hybrid format (supervised in clinic plus home-based/unsupervised exercise), tailored to the needs and preferences of the individual patient. The intervention will be divided into three, progressive phases to ensure the appropriate stimulus for adaptation. In the BASE phase (0-6 weeks), participants will attend a 1-hour supervised session (remotely through teleconferencing for remote patients) once per week. These sessions will be complimented by two additional 30–45-minute home sessions per week. Supervised sessions will be designed to introduce and instruct patients on the strength, aerobic and balance exercise used throughout the intervention. Strength exercises will be primarily based on compound (i.e. multijoint) exercises from a standing position over a repetition range of 8-15 reps using a combination of bodyweight and free weights to provide movement resistance. Progressive balance exercise is introduced to challenge balance by decreasing arm support, decreasing the base of support and then increasing the complexity of movements. Aerobic exercise will be gradually introduced primarily through walking exercise regulated using a modified Borg scale to prescribe a level of perceived exertion, with calibration from performance during baseline cardiopulmonary exercise testing. Alternative modes of exercise will be permitted to align with participant needs and preferences. Participants will be encouraged to progressively increase weekly aerobic exercise volume by 10-15 minutes per week up to 210 minutes of moderate intensity physical activity per week. During the ADAPTATION phase (7-12 weeks), in-person sessions will decrease to fortnightly, replaced by remote sessions in alternate weeks (non-metropolitan patients will continue to receive weekly remote sessions). Home sessions will increase to three times per week, with graded increases in strength exercise (reps and resistance) and aerobic exercise (time & intensity) stimuli at the discretion of the clinical exercise physiologist. During the MAINTENANCE phase (13-26 weeks), patients may opt to receive an in-person or remote session led by a clinical exercise physiologist each fortnight, with home exercise prescribed for a total of five sessions per week with continuation in progression of strength, balance and aerobic exercise. Session intensity at each stage will be progressed over the intervention, each category is . Phase 1 - BASE is planned to start with external prescription as a 3-5/10 RPE for external prescription and 5-7/10 RPE for clinician delivered. Phase 2 - ADAPTION is planned to progressively taper from the BASE intensity to 4-7/10 RPE for external prescription and 7-9/10 RPE for clinician delivered Phase 2 - MAINTENANCE is planned to continue with external prescription at 4-7/10 RPE for external prescription and 7-9/10 RPE for clinician delivered. To monitor and assess adherence participants will be required to maintain a physical activity and exercise diary.
Sponsors
Study design
Eligibility
Inclusion criteria
• Patients with diagnosed AF • Aged equal to or greater than 60 years at the time of enrolment • Early or established frailty as determined by Fried Frailty Phenotype Score greater than or equal to 1 OR Frailty Index greater than or equal to 0.1
Exclusion criteria
• Cardiac surgery (excluding AF ablation) or myocardial infarction within the past 12 months. • Left ventricular systolic dysfunction (LV Ejection Fraction less than 35%). • Significant cardiac valvulopathy (except functional mitral and tricuspid regurgitation). • Active malignancy, active autoimmune or systemic inflammatory disease; severe renal or hepatic failure. • Chronic obstructive pulmonary disorder • Unstable ventricular arrhythmias in the preceding 3 months. • Inability to participate in an exercise program due to musculoskeletal or neurological disease or other active diseases limiting participation in physical exercise. • Pregnancy. • Ongoing participation in exercise program greater than 90 minutes MVPA per week. • Acute injury or illness limiting physical function • Physical inability to complete assessment battery. • Subjectively determined safety risk to participating in external exercise prescription