title: Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial.
abstract: BACKGROUND
  The use of noninvasive intermittent positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure remains controversial as long-term data are almost lacking. The aim was to compare the outcome of 2-year home-based nocturnal NIPPV in addition to rehabilitation (NIPPV + PR) with rehabilitation alone (PR) in COPD patients with chronic hypercapnic respiratory failure.
  
  
  METHODS
  Sixty-six patients could be analyzed for the two-year home-based follow-up period. Differences in change between the NIPPV + PR and PR group were assessed by a linear mixed effects model with a random effect on the intercept, and adjustment for baseline values. The primary outcome was health-related quality of life (HRQoL); secondary outcomes were mood state, dyspnea, gas exchange, functional status, pulmonary function, and exacerbation frequency.
  
  
  RESULTS
  Although the addition of NIPPV did not significantly improve the Chronic Respiratory Questionnaire compared to rehabilitation alone (mean difference in change between groups -1.3 points (95% CI: -9.7 to 7.4)), the addition of NIPPV did improve HRQoL assessed with the Maugeri Respiratory Failure questionnaire (-13.4% (-22.7 to -4.2; p = 0.005)), mood state (Hospital Anxiety and Depression scale -4.0 points (-7.8 to 0.0; p = 0.05)), dyspnea (Medical Research Council -0.4 points (-0.8 to -0.0; p = 0.05)), daytime arterial blood gases (PaCO2 -0.4 kPa (-0.8 to -0.2; p = 0.01); PaO2 0.8 kPa (0.0 to 1.5; p = 0.03)), 6-minute walking distance (77.3 m (46.4 to 108.0; p < 0.001)), Groningen Activity and Restriction scale (-3.8 points (-7.4 to -0.4; p = 0.03)), and forced expiratory volume in 1 second (115 ml (19 to 211; p = 0.019)). Exacerbation frequency was not changed.
  
  
  CONCLUSIONS
  The addition of NIPPV to pulmonary rehabilitation for 2 years in severe COPD patients with chronic hypercapnic respiratory failure improves HRQoL, mood, dyspnea, gas exchange, exercise tolerance and lung function decline. The benefits increase further with time.
  
  
  BACKGROUND
  ClinicalTrials.Gov (ID NCT00135538).
authors.affiliation: Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. m.l.duiverman@umcg.nl
authors.forename: Marieke L
authors.initials: ML
authors.lastname: Duiverman
authors.forename: Johan B
authors.initials: JB
authors.lastname: Wempe
authors.forename: Gerrie
authors.initials: G
authors.lastname: Bladder
authors.forename: Judith M
authors.initials: JM
authors.lastname: Vonk
authors.forename: Jan G
authors.initials: JG
authors.lastname: Zijlstra
authors.forename: Huib A M
authors.initials: HA
authors.lastname: Kerstjens
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Wijkstra
mesh_terms: D000328:Adult; D000368:Aged; D005081:Exercise Therapy / Q000379:methods* / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D018575:Home Care Services, Hospital-Based / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D011175:Positive-Pressure Respiration / Q000379:methods* / Q000639:trends; D029424:Pulmonary Disease, Chronic Obstructive / Q000523:psychology* / Q000534:rehabilitation / Q000628:therapy*; D011788:Quality of Life / Q000523:psychology*; D012129:Respiratory Function Tests / Q000639:trends