Early hybrid cardiac rehabilitation in congenital heart disease: the QUALIREHAB trial

Author:

Amedro Pascal12ORCID,Gavotto Arthur34ORCID,Huguet Helena5,Souilla Luc4ORCID,Huby Anne-Cecile12,Matecki Stefan4ORCID,Cadene Anne5,De La Villeon Gregoire36,Vincenti Marie346,Werner Oscar36ORCID,Bredy Charlene37,Lavastre Kathleen3,Abassi Hamouda34,Cohen Sarah8,Hascoet Sebastien8ORCID,Dauphin Claire9,Chalard Aurelie9,Dulac Yves10ORCID,Souletie Nathalie10,Bouvaist Helene11ORCID,Douchin Stephanie11ORCID,Lachaud Matthias11ORCID,Ovaert Caroline12ORCID,Soulatges Camille12,Combes Nicolas13ORCID,Thambo Jean-Benoit12ORCID,Iriart Xavier1ORCID,Bajolle Fanny14ORCID,Bonnet Damien14ORCID,Ansquer Helene15,Delpey Jean-Guillaume15,Cohen Laurence16,Picot Marie-Christine517ORCID,Guillaumont Sophie36ORCID, ,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

Affiliation:

1. Department of Fetal, Pediatric and Adult Congenital Cardiology, M3C National CHD Reference Centre, Bordeaux University Hospital, Haut-Leveque Hospital , Avenue de Magellan, 33604 Pessac Cedex , France

2. IHU Liryc, INSERM 1045, University of Bordeaux , Avenue du Haut-Leveque, 33600 Pessac , France

3. Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Montpellier University Hospital , Montpellier , France

4. PhyMedExp, INSERM, CNRS, University of Montpellier , Montpellier , France

5. Epidemiology and Clinical Research Department, University Hospital, University of Montpellier , Montpellier , France

6. Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute , Palavas-Les-Flots , France

7. Fontfroide Cardiac Rehabilitation Center , 1800 rue de Saint-Priest, 34097 Montpellier , France

8. Pediatric and Congenital Cardiology Department, M3C National Reference CHD Centre, Marie-Lannelongue Hospital , Le Plessis-Robinson , France

9. Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Clermont-Ferrand University Hospital , Clermont-Ferrand , France

10. Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital , Toulouse , France

11. Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Grenoble University Hospital , Grenoble , France

12. Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, APHM La Timone Hospital , Marseille , France

13. Pediatric and Congenital Cardiology Department, Pasteur Clinic , Toulouse , France

14. Pediatric and Congenital Cardiology Department, M3C National Reference CHD Centre, APHP Necker Hospital , Paris , France

15. Pediatric and Congenital Cardiology Department, Brest University Hospital , Brest , France

16. Fetal, Pediatric and Congenital Private Practice , 8 rue du Conseil de l'Europe, 91300 Massy , France

17. Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier , Montpellier , France

Abstract

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.

Funder

French Ministry of Health

French Society of Cardiology

French Federation of Cardiology

Saint-Pierre Foundation

APARD healthcare provider

Publisher

Oxford University Press (OUP)

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