Protocol of randomized controlled trial to evaluate the effect of moderate exercise training on the functional capacity of patients with an implantable cardioverter defibrillator in a tertiary care center in South India.

Abstract

Background: Cardiac rehabilitation programs are planned to reduce the physiological and psychological stress of Cardiovascular Disease, decrease the risk of mortality secondary to CVD, improve cardiovascular function, and help patients to achieve their highest quality of life. However, data on the safety and efficacy of exercise training (ET) in patients with implantable cardioverter defibrillators (ICDs) is sparse. Exercise interventions in those with an ICD have not been extensively studied.

Materials and methods: A randomized controlled trial will be conducted to determine the effects of moderate ET on the functional capacity of patients with an Implantable cardioverter defibrillator with age group of >18 years, NYHA with grade II and III, EF ≤50%, No evidence of ICD discharge for past 3 months with minimum post-ICD implantation period of a minimum of 3 months. This study includes a total of 70 patients. Random allocation will be used to randomize participants into two groups (35 in each). Home-based walking exercises in the form of aerobic walking will be advised to patients with ICD. They will be advised to walk within the target heart rate for 1 to 24 weeks, which is divided into two components. Initial components included 1-8 weeks of exercise as an Aerobic conditioning component, which includes 1 hour/day x 5 days/week, followed by 9 to 24 weeks as an Aerobic maintenance component, which includes 30 minutes/day x 5 days/week. Adherence to the home walking program with the pulse, spo2, and BP will be tracked using a smartwatch, home exercise log book, and telephone follow-up (if less than 35km - monthly home visit will be done). Functional capacity will be assessed using a 6-minute walk test at baseline and at 6-month intervals.

Conclusion: This study will identify the safety and efficacy of ET among patients with ICD, which will contribute to the important evidence base for cardiac rehabilitation among this group of patients.