None listed
Conditions
Brief summary
This study will provide novel, translational data by evaluating the feasibility and efficacy of a structured, goal directed, exercise and physical activity intervention, coupled with nurse-led education, initiated within one month of implant, for patients receiving a primary prevention ICD. Across Australia, there are ~4000 new recipients of an implanted cardioverter defibrillator (ICD) annually. Recipients are commonly those with left ventricular (LV) dysfunction and/or inducible ventricular arrhythmia. Annual all-cause mortality in patients with prophylactic ICD implantation is approximately 5.0 to 8.5% . Additionally, ICD recipients report lower quality of life coupled with both anxiety and depressive symptoms, which may be exaggerated by higher prevalence of inactivity. The rationale for this study is therefore to combine nurse-led education with a physical activity intervention in new recipients of a primary prevention ICD. Both interventions are clinically effective in patients with heart failure or an ICD, yet have not been comprehensively assessed in a combined strategy.
Interventions
Patients allocated to the intervention group will undergo a 12-week, goal orientated,
combined home and supervised exercise intervention. Weekly exercise will increase progressively in duration from 45 minutes per week in week 1 to 210 minutes per week by week 12. All patients in the intervention arm will attend a supervised exercise clinic once per fortnight for 15-30 minutes with the remainder of exercise being predominantly home-based and monitored by a wearable accelerometer and heart rate t
Patients allocated to the intervention group will undergo a 12-week, goal orientated, combined home and supervised exercise intervention. Weekly exercise will increase progressively in duration from 45 minutes per week in week 1 to 210 minutes per week by week 12. All patients in the intervention arm will attend a supervised exercise clinic once per fortnight for 15-30 minutes with the remainder of exercise being predominantly home-based and monitored by a wearable accelerometer and heart rate tracking device. Exercise will be prescribed according to individualised intensities (using a rating of perceived exertion scale) by an accredited exercise physiologist. Exercise will be predominantly aerobic exercise throughout, with the addition of bodyweight resistance training in week 8. Furthermore, the intervention will include an education component, led by a cardiovascular nurse, regarding disease and device management. Specifically, patients will meet with a study nurse three times through the intervention (week 1, 4, and 8) to discuss and receive education on, their heart condition, how their cardiac devices works, their cardiovascular risk factors and any anxieties or concerns that they may have,
Sponsors
Centre for Heart Rhythm Disorders, University of Adelaide
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Primary prevention implanted cardioverter defibrillator (ICD), without cardiac resynchronization therapy (CRT-D), implanted within past 35 days - Aged >18 - 80 years - LV Ejection Fraction <45%.
Exclusion criteria
- Severely impaired cognitive function, restricting informed consent. - Severely limited walking capacity. - New York Heart Association Class I or IV - Sustained ventricular arrhythmias during baseline cardiopulmonary exercise testing. - Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC/D)
Outcome results
None listed