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Short- and long-term efficacy of a community-based COPD management program in less advanced COPD: a randomized controlled trial |
van Wetering CR, Hoogendoorn M, Mol SM, Rutten-van Molken MP, Schols AM |
Thorax 2010 Jan;65(1):7-13 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
RATIONALE: The effectiveness of pulmonary rehabilitation in advanced COPD is well established. Limited data is available in less advanced disease. METHODS: In a 2-year randomized, controlled trial, 199 patients with on average moderate airflow obstruction but impaired exercise capacity (FEV1: 60% (SD 16%), Wmax < 70%) were randomized to the INTERdisciplinary COMmunity-based COPD management program (INTERCOM) or Usual Care. Intervention consisted of 4 months multidisciplinary rehabilitation followed by a 20-month maintenance phase. Outcomes (4, 12, 24 months): health related quality of life (St George's Respiratory Questionnaire (SGRQ)), exacerbation frequency, Medical Research Council (MRC) dyspnea score, cycle endurance time (CET), 6 minute walking distance (6MWD), skeletal muscle strength and patients' and caregivers' perceived effectiveness. RESULTS: After 4 months between-group comparison (mean (SE)) revealed significant differences in favor of INTERCOM for SGRQ total score 4.06 (1.39) p = 0.04, activity and impact sub scores (p < 0.01), MRC score: 0.33 (0.13), p = 0.01, Wmax: 6.0 (2.3) Watt, p = 0.02, CET: 221 (104) seconds, p = 0.04, 6 MWD: 13 (6) meter, p = 0.02, hand grip force: 4.3 (1.5) pounds, p < 0.01 and FFMI: 0.34 (0.13) kg/m2, p = 0.01. Between-group differences over two years: SGQR: 2.60 (1.3), p = 0.04 and MRC: 0.21 (0.10), p = 0.048, CET: 253 (104) seconds, p = 0.0156, 6MWD: 18 (8) meter, p = 0.0155. Exacerbation frequency was not different (RR 1.29 (95%CI 0.89 to 1.87)). Patients' and caregivers' perceived effectiveness significantly favored the INTERCOM program (p < 0.01). CONCLUSIONS: This study shows that a multidisciplinary, community-based disease management program is also effective in COPD patients with exercise impairment but less advanced airflow obstruction. TRIAL REGISTRATION NUMBER: NCT00840892.
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