International journal of cardiology · 2018
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.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Amedro Pascal, Gavotto Arthur, Legendre Antoine, Lavastre Kathleen, Bredy Charlene, De La Villeon Gregoire, Matecki Stefan, Vandenberghe D'Arcy, Ladeveze Manon, Bajolle Fanny, Bosser Gilles, Bouvaist Helene, Brosset Philippe, Cohen Laurence, Cohen Sarah, Corone Sonia, Dauphin Claire, Dulac Yves, Hascoet Sebastien, Iriart Xavier, Ladouceur Magalie, Mace Loic, Neagu Oxana-Anca, Ovaert Caroline, Picot Marie-Christine, Poirette Laurent, Sidney Frederique, Soullier Camille, Thambo Jean-Benoit, Combes Nicolas, Bonnet Damien, Guillaumont Sophie
Аннотация
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 (VO2max) < 80% and/or a ventilatory anaerobic threshold (VAT) < 55% of predicted VO2max, 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: VO2max, 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).
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 (VO2max) < 80% and/or a ventilatory anaerobic threshold (VAT) < 55% of predicted VO2max, 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: VO2max, 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).