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      ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD

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          Abstract

          The Phase IV, 8-week, randomized, double-blind, placebo-controlled ACTIVATE study (NCT02424344) evaluated the effect of aclidinium/formoterol (AB/FF) 400/12 μg twice daily on lung hyperinflation, exercise capacity, and physical activity in patients with moderate-to-severe COPD. Patients received AB/FF (n=134) or placebo (n=133) (1:1) via the Genuair™/Pressair ® dry powder inhaler for 8 weeks. From Weeks 5 to 8, all patients participated in behavioral intervention (BI; daily messages providing step goals). The primary end point was trough functional residual capacity (FRC) at Week 4. Exercise endurance time and physical activity were assessed at Week 4 (pharmacotherapy only) and at Week 8 (8 weeks of pharmacotherapy plus 4 weeks of BI). Other end points included post-dose FRC, residual volume, and inspiratory capacity (IC) at rest and during exercise. After 4 weeks, trough FRC improved with AB/FF versus placebo but did not reach significance (125 mL; P=0.0690). However, post-dose FRC, residual volume, and IC at rest improved significantly with AB/FF at Week 4 versus placebo (all P<0.0001). AB/FF significantly improved exercise endurance time and IC at isotime versus placebo at Week 4 ( P<0.01 and P<0.0001, respectively) and Week 8 ( P<0.05 and P<0.0001, respectively). AB/FF achieved higher step counts ( P<0.01) with fewer inactive patients ( P<0.0001) at Week 4 versus placebo. Following BI, AB/FF maintained improvements in physical activity at Week 8 and nonsignificant improvements were observed with placebo. AB/FF 400/12 μg demonstrated improvements in lung hyperinflation, exercise capacity, and physical activity versus placebo that were maintained following the addition of BI. A 4-week period of BI might be too short to augment the improvements of physical activity observed with AB/FF.

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          Most cited references 23

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          Physical activity in patients with COPD.

          The present study aimed to measure physical activity in patients with chronic obstructive pulmonary disease (COPD) to: 1) identify the disease stage at which physical activity becomes limited; 2) investigate the relationship of clinical characteristics with physical activity; 3) evaluate the predictive power of clinical characteristics identifying very inactive patients; and 4) analyse the reliability of physical activity measurements. In total, 163 patients with COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage I-IV; BODE (body mass index, airway obstruction, dyspnoea, exercise capacity) index score 0-10) and 29 patients with chronic bronchitis (normal spirometry; former GOLD stage 0) wore activity monitors that recorded steps per day, minutes of at least moderate activity, and physical activity levels for 5 days (3 weekdays plus Saturday and Sunday). Compared with patients with chronic bronchitis, steps per day, minutes of at least moderate activity and physical activity levels were reduced from GOLD stage II/BODE score 1, GOLD stage III/BODE score 3/4 and from GOLD stage III/BODE score 1, respectively. Reliability of physical activity measurements improved with the number of measured days and with higher GOLD stages. Moderate relationships were observed between clinical characteristics and physical activity. GOLD stages III and IV best predicted very inactive patients. Physical activity is reduced in patients with chronic obstructive pulmonary disease from Global Initiative for Chronic Obstructive Lung Disease stage II/ body mass index, airway obstruction, dyspnoea, exercise capacity score 1. Clinical characteristics of patients with chronic obstructive pulmonary disease only incompletely reflect their physical activity.
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            Validity of physical activity monitors during daily life in patients with COPD.

            Symptoms during physical activity and physical inactivity are hallmarks of chronic obstructive pulmonary disease (COPD). Our aim was to evaluate the validity and usability of six activity monitors in patients with COPD against the doubly labelled water (DLW) indirect calorimetry method. 80 COPD patients (mean ± sd age 68 ± 6 years and forced expiratory volume in 1 s 57 ± 19% predicted) recruited in four centres each wore simultaneously three or four out of six commercially available monitors validated in chronic conditions for 14 consecutive days. A priori validity criteria were defined. These included the ability to explain total energy expenditure (TEE) variance through multiple regression analysis, using TEE as the dependent variable with total body water (TBW) plus several physical activity monitor outputs as independent variables; and correlation with activity energy expenditure (AEE) measured by DLW. The Actigraph GT3X (Actigraph LLC, Pensacola, FL, USA), and DynaPort MoveMonitor (McRoberts BV, The Hague, the Netherlands) best explained the majority of the TEE variance not explained by TBW (53% and 70%, respectively) and showed the most significant correlations with AEE (r=0.71, p<0.001 and r=0.70, p<0.0001, respectively). The results of this study should guide users in choosing valid activity monitors for research or for clinical use in patients with chronic diseases such as COPD.
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              Disease Progression and Changes in Physical Activity in Patients with Chronic Obstructive Pulmonary Disease.

              Little is known about the role of physical activity in the course of chronic obstructive pulmonary disease (COPD).
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2017
                24 August 2017
                : 12
                : 2545-2558
                Affiliations
                [1 ]Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
                [2 ]Department of Rehabilitation Sciences, Pulmonary Rehabilitation and Respiratory Division, University Hospital Leuven, KU Leuven, Leuven, Belgium
                [3 ]insaf Respiratory Research Institute GmbH, Wiesbaden, Germany
                [4 ]Barcelona Institute of Global Health (ISGlobal), Barcelona, Spain
                [5 ]Universitat Pompeu Fabra (UPF), Barcelona, Spain
                [6 ]CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
                [7 ]Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy
                [8 ]AstraZeneca PLC, Barcelona, Spain
                [9 ]A. Menarini Farmaceutica Internazionale S.R.L., Firenze, Italy
                [10 ]Laboratorios Menarini, S.A., Badalona, Spain
                Author notes
                Correspondence: Henrik Watz, Pulmonary Research Institute at LungenClinic Grosshansdorf, Wöhrendamm 80, 22927 Grosshansdorf, Germany, Tel +49 410 2888 1122, Fax +49 410 2888 1113, Email h.watz@ 123456pulmoresearch.de
                Article
                copd-12-2545
                10.2147/COPD.S143488
                5574699
                © 2017 Watz et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Respiratory medicine

                copd, hyperinflation, aclidinium, formoterol, exercise capacity, physical activity

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