Study of Cardiac Rehabilitation Effects on Exercise and Quality of Life in Adults With Fontan Failure

What this Trial Is About

This research aims to compare the effects of cardiac rehabilitation versus usual care on adults with Fontan failure, a condition related to heart failure after a specific heart surgery. The study evaluates whether cardiac rehabilitation can improve daily physical activity, exercise tolerance, frailty, and quality of life. It is a multi-center, randomized clinical trial involving patients being seen at Adult Congenital Heart Disease centers. Participants are randomly assigned to either a cardiac rehabilitation program or usual care. Those in the rehabilitation group are referred to a community-based program called Heart Fit for Life, which may be in-person, hybrid, or fully virtual, depending on location. The program includes three sessions per week for 12 weeks. Those in usual care do not start cardiac rehabilitation during the first 16 weeks after randomization. All participants receive a Fitbit to track daily activity. During the study, researchers monitor physical activity through Fitbit step counts and assess exercise tolerance using tests like cardiopulmonary exercise testing. Various measures of frailty, strength, nutrition, and quality of life are also recorded at the start and after about 4 months. Participants receive weekly reminders to encourage engagement. The study observes changes over a period of approximately 120 days after randomization to understand the impact of cardiac rehabilitation on their health and daily functioning.

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation