Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: A randomized controlled trial

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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 (PaCO ₂-0.4 kPa (-0.8 to -0.2; p = 0.01); PaO ₂0.8 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.

Trial registration

ClinicalTrials.Gov (ID NCT00135538).

Related collections

Most cited references 25

Record: found
Abstract: found
Article: not found

Measurement of health status. Ascertaining the minimal clinically important difference.

R Jaeschke, J Singer, G H Guyatt (1989)

In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.

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Record: found
Abstract: found
Article: not found

Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study.

N R Anthonisen, J Connett, J. Kiley … (1994)

To determine whether a program incorporating smoking intervention and use of an inhaled bronchodilator can slow the rate of decline in forced expiratory volume in 1 second (FEV1) in smokers aged 35 to 60 years who have mild obstructive pulmonary disease. Randomized clinical trial. Participants randomized with equal probability to one of the following groups: (1) smoking intervention plus bronchodilator, (2) smoking intervention plus placebo, or (3) no intervention. Ten clinical centers in the United States and Canada. A total of 5887 male and female smokers, aged 35 to 60 years, with spirometric signs of early chronic obstructive pulmonary disease. Smoking intervention: intensive 12-session smoking cessation program combining behavior modification and use of nicotine gum, with continuing 5-year maintenance program to minimize relapse. Bronchodilator: ipratropium bromide prescribed three times daily (two puffs per time) from a metered-dose inhaler. Rate of change and cumulative change in FEV1 over a 5-year period. Participants in the two smoking intervention groups showed significantly smaller declines in FEV1 than did those in the control group. Most of this difference occurred during the first year following entry into the study and was attributable to smoking cessation, with those who achieved sustained smoking cessation experiencing the largest benefit. The small noncumulative benefit associated with use of the active bronchodilator vanished after the bronchodilator was discontinued at the end of the study. An aggressive smoking intervention program significantly reduces the age-related decline in FEV1 in middle-aged smokers with mild airways obstruction. Use of an inhaled anticholinergic bronchodilator results in a relatively small improvement in FEV1 that appears to be reversed after the drug is discontinued. Use of the bronchodilator did not influence the long-term decline of FEV1.

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Effects of pulmonary rehabilitation on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease.

R Prewitt, Maren Limberg, L Ries … (1995)

To compare the effects of comprehensive pulmonary rehabilitation with those of education alone on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease. Randomized clinical trial. University medical center. 119 outpatients with chronic obstructive pulmonary disease that was stable while patients received a standard medical regimen. Patients were randomly assigned to either an 8-week comprehensive pulmonary rehabilitation program or to an 8-week education program. Pulmonary rehabilitation consisted of twelve 4-hour sessions that included education, physical and respiratory care instruction, psychosocial support, and supervised exercise training. Monthly reinforcement sessions were held for 1 year. The education group attended four 2-hour sessions that included video-tapes, lectures, and discussions but not individual instruction or exercise training. Pulmonary function, maximum exercise tolerance and endurance, gas exchange, symptoms of perceived breathlessness and muscle fatigue with exercise, shortness of breath, self-efficacy for walking, depression, general quality of well-being, and hospitalizations associated with pulmonary diseases. Patients were followed for 6 years. Compared with education alone, comprehensive pulmonary rehabilitation produced a significantly greater increase in maximal exercise tolerance (+1.5 metabolic equivalents [METS] compared with +0.6 METS [P < 0.001]; maximal oxygen uptake, +0.11 L/min compared with +0.03 L/min [P = 0.06]), exercise endurance (+10.5 minutes compared with +1.3 minutes [P < 0.001]), symptoms of perceived breathlessness (score of -1.5 compared with +0.2 [P < 0.001]) and muscle fatigue (score of -1.4 compared with -0.2 [P < 0.01]), shortness of breath (score of -7.0 compared with +0.6 [P < 0.01]), and self-efficacy for walking (score of +1.4 compared with +0.1 [P < 0.05]). There were slight but nonsignificant differences in survival (67% compared with 56% [P = 0.32]) and duration of hospital stay (-2.4 days/patient per year compared with +1.3 days/patient per year [P = 0.20]). Measures of lung function, depression, and general quality of life did not differ between groups. Differences tended to diminish after 1 year of follow-up. Comprehensive pulmonary rehabilitation significantly improved exercise performance and symptoms for patients with moderate to severe chronic obstructive pulmonary disease. Benefits were partially maintained for at least 1 year and tended to diminish after that time.

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Author and article information

Journal

Journal ID (nlm-ta): Respir Res

Title: Respiratory Research

Publisher: BioMed Central

ISSN (Print): 1465-9921

ISSN (Electronic): 1465-993X

Publication date (Print): 2011

Publication date (Electronic): 23 August 2011

Volume: 12

Issue: 1

Page: 112

Affiliations

[1 ]Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

[2 ]Department of Home Mechanical Ventilation, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

[3 ]Center for Rehabilitation, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

[4 ]Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

[5 ]Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

Article

Publisher ID: 1465-9921-12-112

DOI: 10.1186/1465-9921-12-112

PMC ID: 3182911

PubMed ID: 21861914

SO-VID: b2017752-9700-4ca9-810e-3c916d858afb

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: A randomized controlled trial

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Abstract

Background

Methods

Results

Conclusions

Trial registration

Related collections

Inflamed lung in vitro co-culture models

Most cited references 25

Measurement of health status. Ascertaining the minimal clinically important difference.

Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study.

Effects of pulmonary rehabilitation on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease.

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