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Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial
Authors:Juan B. Galdiz  Alba Gómez  Diego Rodriguez  Rosa Guell  Pilar Cebollero  Javier Hueto  Pilar Cejudo  Francisco Ortega  Itxaso Sayago  Susana Chic  Marta Iscar  Carlos Amado  Gemma Rodríguez Trigo  Borja G. Cosio  Victor Bustamante  Josèc) Ignacio Pijoan
Affiliation:1. Respiratory Department, Hospital Universitario Cruces, Osakidetza, Biocruces Bizkaia Health Research Institute, CibeRes, Barakaldo, Spain;2. Unitat Rehabilitació Cardio-Respiratoria, Hospital Universitari Vall d?tm)Hebron, Barcelona, Spain;3. Respiratory Department, Hospital del Mar, CibeRes, Barcelona, Spain;4. Respiratory Department, Hospital de la Santa Creu i San Pau, CibeRes, Barcelona, Spain;5. Respiratory Department, Complejo Hospitalario Navarra, Pamplona, Spain;6. Instituto de Biomedicina de Sevilla, Unidad Mèc)dico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocío, Sevilla, Spain;7. Instituto de Biomedicina de Sevilla, Unidad Mèc)dico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocio, CibeRes, Sevilla, Spain;8. Respiratory Department, Clínica Asunción, Tolosa, Gipuzkoa, Spain;9. Internal Medicine Department (Respiratory Unit), Hospital de Mendaro, Osakidetza, Mendaro, Gipuzkoa, Spain;10. Respiratory Department, Hospital General de Asturias, Oviedo, Spain;11. Respiratory Department, Hospital Universitario Marquèc)s de Valdecilla, Santander, Spain;12. Respiratory Department, Hospital Álvaro Cunqueiro, Vigo, Spain;13. Respiratory Department, Hospital Universitary Son Espases, Palma de Mallorca, CibeRes, Spain;14. Respiratory Department, Hospital Universitario Basurto, Bilbao, Spain;15. Clinical Epidemiology Unit, Hospital Universitario de Cruces, Biocruces Bizkaia, Health Research Institute, Bilbao, Spain
Abstract:BackgroundThere is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR).Research questionTo determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR.Study design and methodsA multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly (usual care).ResultsNinety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9 m (95% CI ∧4.1/+43.8)] and Chronic Respiratory Disease Questionnaire ? Emotion score [0.4 points (0?0.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.0?15.4)] and Chronic Respiratory Disease Questionnaire ? Emotion [0.5, (0.2?0.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8 m (∧32.3/0.8) in linear models.ConclusionsThe TelePR maintenance strategy was both feasible and safe but failed to show superiority over usual care, despite improvements in some HRQoL domains. Acute exacerbations may have an important negative influence on long-term physical function.ClinicalTrials.gov identifierNCT03247933.
Keywords:Chronic obstructive pulmonary disease  Telerehabilitation Programme  Maintenance  Enfermedad pulmonar obstructiva crónica  Programa de telerrehabilitación  Mantenimiento
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