Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods

INTERNATIONAL JOURNAL OF CARDIOLOGY

卷:283

Article

Amedro, Pascal^1,2  Gavotto, Arthur^1,3  Legendre, Antoine⁴  Lavastre, Kathleen¹  Bredy, Charlene^1,19  De La Villeon, Gregoire^1,3  Matecki, Stefan^1,2  Vandenberghe, D'Arcy¹  Ladeveze, Manon¹  Bajolle, Fanny⁴  Bosser, Gilles⁵  Bouvaist, Helene⁶  Brosset, Philippe⁷  Cohen, Laurence⁸  Cohen, Sarah⁹  Corone, Sonia¹⁰  Dauphin, Claire¹¹  Dulac, Yves¹²  Hascoet, Sebastien⁹  Iriart, Xavier¹³  Ladouceur, Magalie¹⁴  Mace, Loic¹⁵  Neagu, Oxana-Anca¹⁶  Ovaert, Caroline^15,21  Picot, Marie-Christine¹⁷  Poirette, Laurent¹⁸  Sidney, Frederique¹⁹  Soullier, Camille²⁰  Thambo, Jean-Benoit¹³  Combes, Nicolas²²  Bonnet, Damien⁴  Guillaumont, Sophie^1,3 

[1] CHU Montpellier, Paediat & Congenital Cardiol Dept, M3C Reg Reference CHD Ctr, Montpellier, France

[2] Univ Montpellier, INSERM, CNRS, PhyMedExp, Montpellier, France

[3] Inst St Pierre, Paediat Cardiol & Rehabil Ctr, Palavas Les Flots, Les Flots, France

[4] Paris Descartes Univ, Sorbonne Paris Cite, Necker Enfants Malad, AP HP,Paediat Cardiol Dept,M3C Natl Reference CHD, Paris, France

[5] Univ Hosp Nancy, Childrens Hosp, M3C Reg Reference CHD Ctr, Dept Paediat Cardiol, Vandoeuvre Les Nancy, France

[6] CHU Grenoble, M3C Reg Reference CHD Ctr, Dept Cardiol, Grenoble, France

[7] CHU Limoges, Mother & Children Hosp, Limoges, France

[8] CHD Private Med Off, Massy, France

[9] Paris Sud Univ, Marie Lannelongue Hosp, M3C Natl Reference CHD Ctr, Paris Sud Fac Med,INSERM,U999, Le Plessis Robinson, France

[10] Hosp Bligny, Cardiac Rehabil Ctr, Bris Sous Forge, France

[11] Gabriel Montpied Univ Hosp, M3C Reg Reference CHD Ctr, Dept Cardiol, Clermont Ferrand, France

[12] CHU Toulouse, Childrens Hosp, M3C Reg Reference CHD Ctr, Paediat Cardiol Unit, Toulouse, France

[13] CHU Bordeaux, M3C Natl Reference CHD Ctr, Hop Cardiol Haut Leveque, Paediat & Adult Congenital Heart Dis Dept, Pessac, France

[14] Hop Europeen Georges Pompidou, M3C Natl Reference CHD Ctr, Dept Cardiol, Adult Congenital Heart Dis Unit, Paris, France

[15] La Timone Univ Hosp, AP HM, M3C Reg Reference CHD Ctr, Paediat & Congenital Med Surg Cardiol Dept, Marseille, France

[16] Cardiac Rehabil Ctr, Beaumont De Lomagne, France

[17] CHU Montpellier, Dept Epidemiol & Biostat, Montpellier, France

[18] Leon Berard Hosp, Cardiac Rehabil Ctr, Hyeres, France

[19] Fontfroide Clin, Cardiac Rehabil Ctr, Montpellier, France

[20] Caremeau Univ Hosp, Dept Cardiol, Nimes, France

[21] Aix Marseille Univ, INSERM UMR 1251, Med Genet Lab, Marseille, France

[22] Clin Pasteur, Dept Cardiol, Toulouse, France

关键词: Cardiac rehabilitation;    Congenital heart defect;    Health-related quality of life;    Cardiovascular deconditioning;    Health education;    Secondary prevention;   

DOI  :  10.1016/j.ijcard.2018.12.050

来源: Elsevier

【 摘 要 】

Background: Advances in congenital heart disease (CHD) have transferred the mortality from childhood to adulthood. Exercise capacity in young patients with CHD remains lower than in the general population, resulting in deconditioning and impaired quality of life. Evidence based-medicine in cardiac rehabilitation in this age group with CHD remains limited. We present the QUALI-REHAB study rationale, design and methods. Methods: The QUALI-REHAB trial is a nationwide, multicentre, randomised, controlled study, aiming to assess the impact of a combined centre and home-based cardiac rehabilitation program on the quality of life of adolescents and young adults (13 to 25 years old) with CHD. Patients with a maximum oxygen uptake (VO2(max)) < 80% and/or a ventilatory anaerobic threshold (VAT) < 55% of predicted VO2(max), will be eligible. Patients will be randomised into 2 groups (12-week cardiac rehabilitation program vs. controls). The primary outcome is the change in the PedsQL quality of life score between baseline and 12-month follow-up. A total of 130 patients are required to observe a significant increase of 7 +/- 13.5 points in the PedsQL, with a power of 80% and an alpha risk of 5%. The secondary outcomes are: VO2(max), VAT, stroke volume, clinical outcomes, physical and psychological status, safety and acceptability. Conclusion: After focusing on the survival in CHD, current research is opening on secondary prevention and patient-related outcomes. The QUALI-REHAB trial intends to assess if a combined centre and home-based rehabilitation program, could improve the quality of life and the exercise capacity in youth with CHD. Trial registration: Clinicaltrials.gov (NCT03690518). (c) 2018 Elsevier B.V. All rights reserved.

【 授权许可】

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