Effectiveness of a nurse-led, mHealth-based cardiac rehabilitation program on cardiorespiratory fitness and physical activity in youth with congenital heart disease: A randomized controlled trial.
Youth living with congenital heart disease face impaired cardiorespiratory fitness and reduced physical activity, compromising long-term health outcomes. Cardiac rehabilitation is crucial for optimizing functional capacity and preventing secondary complications, yet access barriers limit participation in traditional center-based programs. Nurse-led, mHealth-based models may improve accessibility and effectiveness.
To evaluate the effectiveness of a nurse-led, mHealth-based cardiac rehabilitation program (HeartFIT) versus usual care on cardiorespiratory fitness and physical activity in youth with congenital heart disease.
A prospective, randomized, open-label, parallel-group controlled trial.
Two tertiary hospitals in Chengdu, China.
Youth aged 8 to 18 years, ≥6 months post-correction for congenital heart disease, with impaired exercise capacity.
Participants (N = 68) were randomized (1:1) to HeartFIT or usual care. HeartFIT comprised a 12-week, nurse-led, home-based mHealth cardiac rehabilitation intervention (via WeChat), with the entire program design grounded in the Individual and Family Self-Management Theory and incorporating specific Behavior Change Techniques. The program featured individualized exercise prescriptions based on baseline cardiopulmonary exercise testing and risk stratification, tailored health education, goal-setting with self-monitoring, and remote nursing support. The primary outcome was change in cardiorespiratory fitness (peak oxygen uptake, VO2 peak) measured by cardiopulmonary exercise testing. Secondary outcomes included other cardiopulmonary exercise testing parameters (oxygen pulse, exercise duration, maximal workload, ventilatory efficiency) and physical activity levels assessed by accelerometry and the Physical Activity Questionnaire. Analysis of covariance (ANCOVA), adjusting for baseline values, was used to determine between-group differences.
The HeartFIT group demonstrated statistically significantly greater improvement in VO2 peak versus controls (adjusted mean difference: 3.60 ml·kg-1·min-1, 95% CI 1.48 to 5.73; P = 0.001). Significant improvements favoring HeartFIT were also observed in oxygen pulse (0.78 ml·beat-1), exercise duration (0.76 min), maximal workload (11.70 W), and physical activity levels (P = 0.004 for accelerometry; P = 0.001 for Physical Activity Questionnaire). No serious adverse events occurred.
The nurse-led, mHealth-based cardiac rehabilitation program effectively improved cardiorespiratory fitness and physical activity in youth with congenital heart disease, offering a safe and scalable approach for accessible pediatric cardiac rehabilitation.
Chinese Clinical Trial Registry (ChiCTR2100050259, Registered 24/08/2021, first recruitment 08/11/2021).
To evaluate the effectiveness of a nurse-led, mHealth-based cardiac rehabilitation program (HeartFIT) versus usual care on cardiorespiratory fitness and physical activity in youth with congenital heart disease.
A prospective, randomized, open-label, parallel-group controlled trial.
Two tertiary hospitals in Chengdu, China.
Youth aged 8 to 18 years, ≥6 months post-correction for congenital heart disease, with impaired exercise capacity.
Participants (N = 68) were randomized (1:1) to HeartFIT or usual care. HeartFIT comprised a 12-week, nurse-led, home-based mHealth cardiac rehabilitation intervention (via WeChat), with the entire program design grounded in the Individual and Family Self-Management Theory and incorporating specific Behavior Change Techniques. The program featured individualized exercise prescriptions based on baseline cardiopulmonary exercise testing and risk stratification, tailored health education, goal-setting with self-monitoring, and remote nursing support. The primary outcome was change in cardiorespiratory fitness (peak oxygen uptake, VO2 peak) measured by cardiopulmonary exercise testing. Secondary outcomes included other cardiopulmonary exercise testing parameters (oxygen pulse, exercise duration, maximal workload, ventilatory efficiency) and physical activity levels assessed by accelerometry and the Physical Activity Questionnaire. Analysis of covariance (ANCOVA), adjusting for baseline values, was used to determine between-group differences.
The HeartFIT group demonstrated statistically significantly greater improvement in VO2 peak versus controls (adjusted mean difference: 3.60 ml·kg-1·min-1, 95% CI 1.48 to 5.73; P = 0.001). Significant improvements favoring HeartFIT were also observed in oxygen pulse (0.78 ml·beat-1), exercise duration (0.76 min), maximal workload (11.70 W), and physical activity levels (P = 0.004 for accelerometry; P = 0.001 for Physical Activity Questionnaire). No serious adverse events occurred.
The nurse-led, mHealth-based cardiac rehabilitation program effectively improved cardiorespiratory fitness and physical activity in youth with congenital heart disease, offering a safe and scalable approach for accessible pediatric cardiac rehabilitation.
Chinese Clinical Trial Registry (ChiCTR2100050259, Registered 24/08/2021, first recruitment 08/11/2021).