Early hybrid cardiac rehabilitation in congenital heart disease: the QUALIREHAB trial
Pascal Amedro, Arthur Gavotto, Hélèna Huguet, Luc Souilla, Anne-Cécile Huby, Stéfan Matecki, Anne Cadene, Grégoire De La Villeon, Marie Vincenti, Oscar Werner, Charlène Bredy, Kathleen Lavastre, Hamouda Abassi, Sarah Cohen, Sébastien Hascoët, Claire Dauphin, Aurélie Chalard, Yves Dulac, Nathalie Souletie, Hélène Bouvaist, Stéphanie Douchin, Matthias Lachaud, Caroline Ovaert, Camille Soulatges, Nicolas Combes, Jean‐Benoît Thambo, Xavier Iriart, Fanny Bajolle, Damien Bonnet, Hélène Ansquer, Jean-Guillaume Delpey, Laurence Cohen, Marie‐Christine Picot, Sophie Guillaumont, the QUALIREHAB Study Group, Pascal Amedro, Arthur Gavotto, Hélèna Huguet, Luc Souilla, Anne-Cécile Huby, Johanna Calderon, Stéfan Matecki, Anne Cadene, Grégoire De La Villeon, Marie Vincenti, Oscar Werner, D. Vandenberghe, Charlène Bredy, Kathleen Lavastre, Hamouda Abassi, Sarah Cohen, Sébastien Hascoët, Claire Dauphin, Aurelie Chalard, Yves Dulac, Nathalie Souletie, Philippe Acar, Hélène Bouvaist, Stéphanie Douchin, Matthias Lachaud, Caroline Ovaert, Camille Soulatges, Nicolas Combes, Jean‐Benoît Thambo, Xavier Iriart, Émilie Testet, Fanny Bajolle, Antoine Legendre, Damien Bonnet, Hélène Ansquer, Jean-Guillaume Delpey, Laurence Cohen, Victor Pommier, Rémi Vincent, Frederique Sidney-Hetmaniak, Laurent Poirette, Sonia Corone, Cécile Rocca, M Noirclerc, Oxana-Anca Neagu, Hervé Ngayap-Nemkam, I. Kammache, Clara Bourgarde, Jean-Marie Chevalier, Christelle Pons, Marie‐Christine Picot, Sophie Guillaumont
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.