Maria-Rosa Güell1, Pilar Cejudo2,3, Francisco Ortega2,3, M Carmen Puy1, Gema Rodríguez-Trigo4, José Ignacio Pijoan5,6,7, Lorea Martinez-Indart5, Amaia Gorostiza5, Khaled Bdeir8, Bartolome Celli9, Juan B Galdiz5,10. 1. 1 Hospital de la Santa Creu I Sant Pau, Barcelona, Spain. 2. 2 Hospital Virgen Rocío, Sevilla, Spain. 3. 3 Instituto de Biomedicina de Sevilla, Sevilla, Spain. 4. 4 Hospital Clínico San Carlos, Madrid, Spain. 5. 5 Hospital Universitario Cruces, Barakaldo-Biocruces Health Research Institute, Barakaldo, Spain. 6. 6 CIBER de Epidemiología y Salud Pública, Madrid, Spain. 7. 7 Spanish Clinical Research Network, Madrid, Spain. 8. 8 Hospital La Madalena, Castellón, Spain. 9. 9 Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, Massachusetts; and. 10. 10 CibeRes, Madrid, Spain.
Abstract
RATIONALE: In chronic obstructive pulmonary disease (COPD), the benefits of pulmonary rehabilitation (PR) tend to wane over time. Whether maintenance techniques may help sustain the benefits achieved after completion of the initial PR program remains controversial. OBJECTIVES: To determine whether a long-term (3-yr) maintenance program after PR preserves the short-term effects on outcomes in patients with COPD. METHODS: This was a multicenter prospective randomized trial including 143 patients with moderate-severe COPD, with 3 years of PR maintenance following an 8-week outpatient PR program. Patients were randomized to maintenance intervention group (IG) and standard monitoring program or control group (CG). The effects on BODE index, 6-minute-walk test distance (6MWD), and health-related quality of life were compared at 12, 24, and 36 months. MEASUREMENTS AND MAIN RESULTS: A total of 138 (96.5%) completed the 8-week program. At this time, all outcomes (BODE, 6MWD, and health-related quality of life) showed clinically and statistically significant improvements (P ≤ 0.001). During the follow-up period, the magnitude of change in 6MWD differed between IG and CG (P = 0.042), with a slight initial increase in the IG during the first year and smaller decline afterward. The BODE index changes differed between baseline and measurements at Month 24 (P = 0.043). At 3 years, the adherence rate of IG patients was 66% and 17% for the CG group (P < 0.001). CONCLUSIONS: This study shows a 2-year beneficial effect of a program of rehabilitation maintenance on the BODE index and 6MWD when compared with a standard strategy. This effect vanishes after the second year of follow-up. Clinical trial registered with www.clinicaltrials.gov (NCT 01090999).
RCT Entities:
RATIONALE: In chronic obstructive pulmonary disease (COPD), the benefits of pulmonary rehabilitation (PR) tend to wane over time. Whether maintenance techniques may help sustain the benefits achieved after completion of the initial PR program remains controversial. OBJECTIVES: To determine whether a long-term (3-yr) maintenance program after PR preserves the short-term effects on outcomes in patients with COPD. METHODS: This was a multicenter prospective randomized trial including 143 patients with moderate-severe COPD, with 3 years of PR maintenance following an 8-week outpatient PR program. Patients were randomized to maintenance intervention group (IG) and standard monitoring program or control group (CG). The effects on BODE index, 6-minute-walk test distance (6MWD), and health-related quality of life were compared at 12, 24, and 36 months. MEASUREMENTS AND MAIN RESULTS: A total of 138 (96.5%) completed the 8-week program. At this time, all outcomes (BODE, 6MWD, and health-related quality of life) showed clinically and statistically significant improvements (P ≤ 0.001). During the follow-up period, the magnitude of change in 6MWD differed between IG and CG (P = 0.042), with a slight initial increase in the IG during the first year and smaller decline afterward. The BODE index changes differed between baseline and measurements at Month 24 (P = 0.043). At 3 years, the adherence rate of IG patients was 66% and 17% for the CG group (P < 0.001). CONCLUSIONS: This study shows a 2-year beneficial effect of a program of rehabilitation maintenance on the BODE index and 6MWD when compared with a standard strategy. This effect vanishes after the second year of follow-up. Clinical trial registered with www.clinicaltrials.gov (NCT 01090999).
Authors: Elizabeth A Gilliam; Karen L Kilgore; Yuchen Liu; Lauren Bernier; Shana Criscitiello; Daniel Litrownik; Peter M Wayne; Marilyn L Moy; Gloria Y Yeh Journal: Respir Med Date: 2021-05-15 Impact factor: 4.582
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