Early hybrid cardiac rehabilitation in congenital heart disease: the QUALIREHAB trial
Authors: Amedro Pascal , Gavotto Arthur , Huguet Helena , Souilla Luc , Huby Anne-Cecile , Matecki Stefan , Cadene Anne , De La Villeon Gregoire , Vincenti Marie , Werner Oscar , Bredy Charlene , Lavastre Kathleen , Abassi Hamouda , Cohen Sarah , Hascoet Sebastien , Dauphin Claire , Chalard Aurelie , Dulac Yves , Souletie Nathalie , Bouvaist Helene , Douchin Stephanie , Lachaud Matthias , Ovaert Caroline , Soulatges Camille , Combes Nicolas , Thambo Jean-Benoit , Iriart Xavier , Bajolle Fanny , Bonnet Damien , Ansquer Helene , Delpey Jean-Guillaume , Cohen Laurence , Picot Marie-Christine , Guillaumont Sophie ,   the QUALIREHAB Study Group, Amedro Pascal , Gavotto Arthur , Huguet Helena , Souilla Luc , Huby Anne-Cecile , Calderon Johanna , Matecki Stefan , Cadene Anne , De La Villeon Gregoire , Vincenti Marie , Werner Oscar , Vandenberghe D’Arcy , Bredy Charlene , Lavastre Kathleen , Abassi Hamouda , Cohen Sarah , Hascoet Sebastien , Dauphin Claire , Chalard Aurelie , Dulac Yves , Souletie Nathalie , Acar Philippe , Bouvaist Helene , Douchin Stephanie , Lachaud Matthias , Ovaert Caroline , Soulatges Camille , Combes Nicolas , Thambo Jean-Benoit , Iriart Xavier , Testet Emilie , Bajolle Fanny , Legendre Antoine , Bonnet Damien , Ansquer Helene , Delpey Jean-Guillaume , Cohen Laurence , Pommier Victor , Vincent Remi , Sidney-Hetmaniak Frederique , Poirette Laurent , Corone Sonia , Rocca Cecile , Noirclerc Marianne , Neagu Oxana-Anca , Ngayap-Nemkam Hervé , Kammache Isaam , Bourgarde Clara , Chevalier Jean-Marie , Pons Christelle , Picot Marie-Christine , Guillaumont Sophie 
Published: March 2024

Abstract

Background and Aims
Cardiopulmonary fitness in congenital heart disease (CHD) decreases faster than in the general population resulting in impaired health-related quality of life (HRQoL). As the standard of care seems insufficient to encourage and maintain fitness, an early hybrid cardiac rehabilitation programme could improve HRQoL in CHD.

Methods
The QUALIREHAB multicentre, randomized, controlled trial evaluated and implemented a 12-week centre- and home-based hybrid cardiac rehabilitation programme, including multidisciplinary care and physical activity sessions. Adolescent and young adult CHD patients with impaired cardiopulmonary fitness were randomly assigned to either the intervention (i.e. cardiac rehabilitation) or the standard of care. The primary outcome was the change in HRQoL from baseline to 12-month follow-up in an intention-to-treat analysis. The secondary outcomes were the change in cardiovascular parameters, cardiopulmonary fitness, and mental health.

Results
The expected number of 142 patients was enroled in the study (mean age 17.4 ± 3.4 years, 52% female). Patients assigned to the intervention had a significant positive change in HRQoL total score [mean difference 3.8; 95% confidence interval (CI) 0.2; 7.3; P = .038; effect size 0.34], body mass index [mean difference −0.7 kg/m2 (95% CI −1.3; −0.1); P = .022; effect size 0.41], level of physical activity [mean difference 2.5 (95% CI 0.1; 5); P = .044; effect size 0.39], and disease knowledge [mean difference 2.7 (95% CI 0.8; 4.6); P = .007; effect size 0.51]. The per-protocol analysis confirmed these results with a higher magnitude of differences. Acceptability, safety, and short-time effect of the intervention were good to excellent.

Conclusions
This early hybrid cardiac rehabilitation programme improved HRQoL, body mass index, physical activity, and disease knowledge, in youth with CHD, opening up the possibility for the QUALIREHAB programme to be rolled out to the adult population of CHD and non-congenital cardiac disease.