Remote Sophrology in Congenital Heart Disease: The SOPHROCARE Randomized Controlled Trial

Despite significant medical advances in recent decades, cardiopulmonary fitness decreases faster in youth with congenital heart disease (CHD) than in healthy peers, resulting in impaired health-related quality of life (HRQoL) and increased cardiovascular risk. Apart from cardiac rehabilitation, non-pharmacological preventive interventions have been scarcely evaluated in this population. Sophrology, a mind-body method involving dynamic relaxation in full awareness, breathing exercises, and imagination, has demonstrated benefits for mental health and well-being. This multicenter randomized controlled trial evaluated the impact of a remote sophrology program on cardiopulmonary fitness and HRQoL in youth with CHD.

A total of 200 13-to-25-year-old CHD patients were randomly assigned to either the intervention (i.e., eight remote individual sophrology sessions), or the standard of care. The primary outcome was the change in maximum oxygen uptake (VO2max) measured by cardiopulmonary exercise testing from baseline to 12 months. Secondary outcomes included HRQoL and mental health assessments. No significant VO2max group difference was observed (mean difference -0.11; 95% CI -2.02, 1.79; p=0.91). The HRQoL "Mental Component Summary", "Mental Health" and "Vitality" SF-36 scores increased in the young adult intervention subgroup (18-25 years) by 8.98 (95% CI 2.73; 15.23, p<0.01, effect size 0.84), 14.49 (95% CI 3.17; 25.81, p=0.01, effect size 0.74), and 15.75 (95% CI 3.97; 27.53, p<0.01, effect size 0.78) points, respectively.

The remote sophrology program did not improve cardiopulmonary fitness, but significantly enhanced HRQoL in young adults with CHD. Integrating mind-body practices into preventive cardiology programs should be further evaluated. Registration:  Clinicaltrials.gov (NCT03999320).