Towards a better understanding of physical activity in people with COPD: predicting physical activity after pulmonary rehabilitation using an integrative competence model.

The integrative Physical Activity-related Health Competence (PAHCO) model specifies competences (movement competence, control competence, and self-regulation competence) that enable people to lead a physically active lifestyle. This longitudinal study analyses the predictive quality of a multidimensional PAHCO assessment for levels of physical activity (PA) and their relevance for quality of life in COPD patients after pulmonary rehabilitation. At the end of an inpatient pulmonary rehabilitation (T2), 350 COPD patients participating in the Stay Active after Rehabilitation (STAR) study underwent assessments, including a six-factor measurement of PAHCO. PA (triaxial accelerometry) and quality of life (Saint George's Respiratory Questionnaire) were recorded 6 weeks (T3) and 6 months (T4) after rehabilitation. Structural equation modelling (SEM) was used to regress the PAHCO assessment on PA, which should, in turn, influence quality of life. In univariable analysis, five and six factors of the PAHCO model were related to PA and quality of life, respectively. Multivariate modelling showed that the predictive analyses for the PA level were dominated by the 6-minute walking test representing movement competence (0.562 ≤ |ß| ≤ 0.599). Affect regulation as an indicator of control competence co-predicted quality of life at T3 and levels of PA at T4. The PA level was, in turn, significantly associated with patients' quality of life (0.306 ≤ |ß| ≤ 0.388). The integrative PAHCO model may be used as a theoretical framework for predicting PA in COPD patients following pulmonary rehabilitation. The results improve our understanding of PA behaviour in COPD patients and bear implications for person-oriented PA promotion.

Impact of acyclovir use on survival of patients with ventilator-associated pneumonia and high load herpes simplex virus replication.

BACKGROUND: Herpes simplex virus (HSV) replication can be detected in the respiratory secretions of a high proportion of ventilated intensive care unit (ICU) patients. However, the clinical significance remains poorly defined. We investigated whether patients with ventilator-associated pneumonia not responding to antibiotics and in whom high levels of HSV could be detected in respiratory secretions benefit from acyclovir treatment. METHODS: Respiratory secretions (bronchoalveolar lavage fluid or tracheal aspirates) were tested for HSV replication by quantitative real-time PCR. ICU survival times, clinical parameters, and radiographic findings were retrospectively compared between untreated and acyclovir treated patients with high (> 105 HSV copies/mL) and low (103-105 HSV copies/mL) viral load. RESULTS: Fifty-seven low and 69 high viral load patients were identified. Fewer patients with high viral load responded to antibiotic treatment (12% compared to 40% of low load patients, p = 0.001). Acyclovir improved median ICU survival (8 vs 22 days, p = 0.014) and was associated with a significantly reduced hazard ratio for ICU death (HR = 0.31, 95% CI 0.11-0.92, p = 0.035) in high load patients only. Moreover, circulatory and pulmonary oxygenation function of high load patients improved significantly over the course of acyclovir treatment: mean norepinephrine doses decreased from 0.05 to 0.02 µg/kg body weight/min between days 0 and 6 of treatment (p = 0.049), and median PaO2/FiO2 ratio increased from 187 to 241 between day 3 and day 7 of treatment (p = 0.02). Chest radiographic findings also improved significantly (p < 0.001). CONCLUSIONS: In patients with ventilator-associated pneumonia, antibiotic treatment failure, and high levels of HSV replication, acyclovir treatment was associated with a significantly longer time to death in the ICU and improved circulatory and pulmonary function. This suggests a causative role for HSV in this highly selected group of patients.

Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: results from a randomised controlled trial.

The value of inspiratory muscle training (IMT) in pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) is unclear. The RIMTCORE (Routine Inspiratory Muscle Training within COPD Rehabilitation) randomised controlled trial examined the effectiveness of IMT added to pulmonary rehabilitation.In total, 611 COPD patients (Global Initiative for Chronic Obstructive Lung Disease stage II-IV) received a 3-week inpatient pulmonary rehabilitation, of which 602 patients were included in the intention-to-treat analyses. The intervention group (n=300) received highly intensive IMT and the control group (n=302) received sham IMT. The primary outcome was maximal inspiratory pressure (PImax). The secondary outcomes were 6-min walk distance, dyspnoea, quality of life and lung function. Outcomes were assessed pre- and post-pulmonary rehabilitation. ANCOVA was used.The intervention group showed higher effects in PImax (p<0.001) and forced inspiratory volume in 1 s (p=0.013). All other outcomes in both study groups improved significantly, but without further between-group differences. Sex and pulmonary rehabilitation admission shortly after hospitalisation modified quality of life effects.IMT as an add-on to a 3-week pulmonary rehabilitation improves inspiratory muscle strength, but does not provide additional benefits in terms of exercise capacity, quality of life or dyspnoea. A general recommendation for COPD patients to add IMT to a 3-week pulmonary rehabilitation cannot be made.

A multicentre validation of the 1-min sit-to-stand test in patients with COPD.

Our aim was to comprehensively validate the 1-min sit-to-stand (STS) test in chronic obstructive pulmonary disease (COPD) patients and explore the physiological response to the test.We used data from two longitudinal studies of COPD patients who completed inpatient pulmonary rehabilitation programmes. We collected 1-min STS test, 6-min walk test (6MWT), health-related quality of life, dyspnoea and exercise cardiorespiratory data at admission and discharge. We assessed the learning effect, test-retest reliability, construct validity, responsiveness and minimal important difference of the 1-min STS test.In both studies (n=52 and n=203) the 1-min STS test was strongly correlated with the 6MWT at admission (r=0.59 and 0.64, respectively) and discharge (r=0.67 and 0.68, respectively). Intraclass correlation coefficients (95% CI) between 1-min STS tests were 0.93 (0.83-0.97) for learning effect and 0.99 (0.97-1.00) for reliability. Standardised response means (95% CI) were 0.87 (0.58-1.16) and 0.91 (0.78-1.07). The estimated minimal important difference was three repetitions. End-exercise oxygen consumption, carbon dioxide output, ventilation, breathing frequency and heart rate were similar in the 1-min STS test and 6MWT.The 1-min STS test is a reliable, valid and responsive test for measuring functional exercise capacity in COPD patients and elicited a physiological response comparable to that of the 6MWT.

Effectiveness of pulmonary rehabilitation for patients with asthma: study protocol of a randomized controlled trial (EPRA).

BACKGROUND: Asthma patients are enrolled in multimodal pulmonary rehabilitation (PR) programs. However, available data for the effectiveness of PR in asthma are sparse. Therefore, the primary aim of this randomized control trial (RCT) is to evaluate short-term (end of rehabilitation) and intermediate-term effectiveness (3 months after rehabilitation) of PR for patients with asthma regarding asthma control (primary outcome) and other outcomes. Secondly, moderator effects of gender, age, baseline asthma control, quality of life, and anxiety will be examined. Thirdly, a longitudinal follow-up study will explore the course of the outcomes over one year and the annual costs. METHODS: The EPRA study is a single-center randomized controlled waiting-list trial in the Bad Reichenhall Clinic. Inclusion criteria include a referral diagnosis for uncontrolled asthma, no cognitive impairment and no very severe co-morbidities that indicate significantly greater illness morbidity than asthma alone. In the intervention group (IG), participants will start PR within 4 weeks after randomization; participants of the control group (CG) will start PR 20 weeks after randomization. Data will be assessed at randomization (T0), after 4 weeks (T1; IG: begin of PR), 7 weeks (T2; IG: end of PR), and 20 weeks (T3, CG: begin of PR). The primary outcome is asthma control at T2/T3. Secondary outcomes are health-related quality of life, functional exercise capacity, dyspnea, anxiety, depression, subjective self-management skills, illness perceptions, sick leave and subjective work ability. Outcomes will be analyzed with analysis of covariance, including baseline values of the respective outcomes as covariates. Healthcare costs will be analyzed with a gamma model with a log-link. A longitudinal follow-up study will generate additional data at 3/6/9/12 months after PR for both IG and CG. Latent change models will be used to analyze the course of the primary and secondary outcomes. Annual cost differences before and after rehabilitation will be compared by paired t-test. DISCUSSION: This RCT will determine the effectiveness of a complex inpatient PR for asthma patients concerning asthma control. Furthermore, important medical and economic information regarding the effectiveness of PR as part of the long-term management of patients with uncontrolled asthma will be generated. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00007740 , May 15, 2015). Protocol version: 1.0 (December, 23, 2016).

Validity of a Self-administered Questionnaire Version of the Transition Dyspnea Index in Patients with COPD.

The transition dyspnea index (TDI) is among the most widely used instruments in chronic obstructive pulmonary disease (COPD) patients to measure changes in dyspnea over time. In its original version it is used as guideline for a structured interview to assess the impact of daily activities on dyspnea in the three subdomains: functional impairment, magnitude of task, and magnitude of effort. However, the TDI is sometimes used as a self-administered paper-and-pencil questionnaire. The validity of this questionnaire format has not been tested, which was the aim of the present study. We tested 190 patients with COPD at start and end of a 3-week inpatient pulmonary rehabilitation program (PR). Dyspnea was assessed with the modified Medical Research Council Scale (mMRC), a questionnaire version of the TDI, and an interview version of the TDI. Group means for the TDI questionnaire and interview version were widely comparable for the TDI summary score and the three TDI subdomains. The scores of both TDI versions were strongly correlated and showed comparable, but only weak, correlations with changes during PR in spirometric lung function and mMRC. Improvement in dyspnea after PR was observed in 89% of patients when using the summary score of the questionnaire TDI, but only in 34% of patients when using the mMRC. The results suggest that a self-administered questionnaire format of the TDI is an adequate instrument for assessing changes in activity-related dyspnea during PR in patients with COPD. The responsiveness of this instrument to effects of PR appears greater than the responsiveness of the mMRC.

Asthma Control Test and Asthma Control Questionnaire: factorial validity, reliability and correspondence in assessing status and change in asthma control.

OBJECTIVE: This study examined the factor structures and reliabilities of the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ-7; ACQ-6) and the correspondence between them in assessing both level and change in asthma control. METHODS: Lung function and questionnaire data for ACT and ACQ were assessed in 113 asthma patients at the beginning (T1) and the end (T2) of inpatient rehabilitation. Confirmatory factor analyses, composite reliability coefficients, Pearson correlations, Cohen's Kappa and positive/negative agreements were computed. RESULTS: Unidimensional factor structure was confirmed for ACT. For ACQ configural invariance (i.e. same factor structure) over time could not be established. Furthermore, in ACQ-7, FEV1 showed no relation to the latent factor. Reliability estimates were 0.86-0.88 (ACT), 0.88-0.92(ACQ-6) and 0.81-0.86 (ACQ-7). Pearson correlations between ACT and ACQ were between 0.75 and 0.90 and tended to be higher at T2. If the aim is to identify patients with either not well-controlled asthma or change in asthma control, concordance was at least moderate (Kappa = 0.52-0.72). Correspondence tended to be lower in identifying patients with well-controlled asthma (Kappa = 0.30-0.79). In some circumstances, ACQ-6 showed higher agreement with ACT than did ACQ-7. CONCLUSIONS: ACT is a unidimensional measure, but factor structure of ACQ remains unclear. Correspondence between ACT and ACQ depends on the aim of the assessment. Including FEV1 in the assessment of asthma control level even lowers reliability of ACQ and concordance with ACT. Our results support GINA (2014) in conceptualizing FEV1 as a risk factor for poor asthma outcome instead of an indicator of level of asthma control.

Asthma control and health-related quality of life one year after inpatient pulmonary rehabilitation: the ProKAR Study.

OBJECTIVES: Although pulmonary rehabilitation (PR) is commonly used for asthmatics in many countries, so far there are no studies addressing the question of whether and for how long an improvement in asthma control (AC) is seen after rehabilitation. The ProKAR study (Prospektive Katamnesestudie Asthma-Rehabilitation) was performed to provide data concerning the short- and long-term impact of PR on AC. METHODS: Two-hundred one adult patients with mild to severe persistent asthma were prospectively followed one year after completion of a 3-week PR program. AC, the primary outcome parameter, and health-related quality of life (HRQoL) were monitored using the Asthma Control Test (ACT) and St. George's Respiratory Questionnaire (SGRQ) at initiation (T0) and end of the PR (T1) and 3, 6 and 12 months thereafter. Pulmonary function, physical fitness (6MWD) and asthmatic inflammation (FENO) were measured at T0 and T1. RESULTS: The proportion of patients with well-controlled asthma (ACT score ≥20) increased from 33.2% to 67.3% after PR and was still at 51% after 12 months. Slight but statistically significant improvements in pulmonary functions and an increase in 6MWD of nearly 60 m were reported at T1. One year after discharge 55.8% of the patients still showed a clinically relevant improvement of at least 4 points in the total SGRQ score. CONCLUSIONS: The multidisciplinary inpatient PR program resulted in significant short and long-term improvement in AC and HRQoL in adult asthmatic patients.

Effect of a Three-Week Inpatient Rehabilitation Program on 544 Consecutive Patients with Very Severe COPD: A Retrospective Analysis.

BACKGROUND: Pulmonary rehabilitation improves exercise capacity, symptoms, and quality of life in chronic obstructive pulmonary disease (COPD) patients, and is therefore recommended in all stages of the disease. However, there are insufficient data on patients with very severe disease. OBJECTIVE: To describe the effect of an in-house multidisciplinary pulmonary rehabilitation program on patients with very severe COPD. METHODS: We performed a retrospective analysis of 544 consecutive patients with very severe COPD (FEV1 0.97 ± 0.26 l) that underwent an in-house pulmonary rehabilitation program (23.44 ± 4.97 days). The studied outcome parameters were the 6-min walk test (6-MWT), health-related quality of life as analyzed by the COPD Assessment Test (CAT) and a dyspnea score [modified Medical Research Council (mMRC) scale], and lung function [forced expiratory volume in 1 s (FEV1) and residual volume (RV)]. RESULTS: We found significant improvements regarding 6-MWT scores (from 321.93 ± 115.67 to 365.82 ± 111.79 m; p < 0.001), CAT scores (from 23.21 ± 6.75 to 19.57 ± 7.35; p < 0.001), mMRC scale scores (from 3.17 ± 1.14 to 2.81 ± 1.22; p < 0.001), and FEV1 (from 0.97 ± 0.26 to 1.08 ± 0.33 l; p < 0.001). A number of baseline variables were significantly correlated with the improvements that occurred during the program (Δ): baseline 6-MWT with Δ6-MWT (r = -0.316; p < 0.001), baseline CAT with ΔCAT (r = -0.302; p < 0.001), baseline mMRC with ΔmMRC (r = -0.444; p < 0.001), and baseline RV with ΔRV (r = -0.284; p < 0.001), demonstrating that improvements were more pronounced in patients with worse baseline characteristics. Patients on long-term oxygen therapy (LTOT) exhibited significantly greater improvements regarding CAT than patients not on LTOT. CONCLUSION: Patients with very severe COPD exhibit clinically meaningful improvements when undergoing pulmonary rehabilitation.

Comparison of recording positions of physical activity in patients with severe COPD undergoing LTOT.

BACKGROUND: Accelerometry is increasingly used to assess physical activity (PA) in patients with chronic obstructive pulmonary disease (COPD). It is not known how the relationship of PA to clinical results depends on the position of the PA sensor. METHODS: We assessed the effect of monitor position by measuring lower extremity (ankle), upper extremity (wrist) and total body movement (hip) in 52 patients with severe COPD (mean [± SD] age, 62 ± 10 years; FEV(1), 38 ± 12% predicted) undergoing long-term oxygen therapy with and without walkers during a pulmonary rehabilitation (PR) program. Sensors were worn 8.5 ± 3.1 days and data was compared to the BODE score and the 6-minute walk distance (6MWD) assessed at the beginning and end of the PR. RESULTS: Mean ankle PA was moderately related to the 6MWD, irrespective of patients being equipped with a walker or not (p < 0.05). Mean PA values were considerably lower in COPD patients with walker compared to patients without for all sensor positions. No significant association was observed between mean hip PA data and 6MWD; however, hip and ankle PA data were moderately related in walker-free and strongly related in walker patients (p < 0.01). In a multivariate regression model only ankle activity was significantly associated with the BODE score (p < 0.01). CONCLUSION: The sensor position had a significant impact on the association between PA recordings and the 6MWD in very severe COPD. In our setting, ankle measurement seemed to best reflect the clinical state of patients.

In-Patient Pulmonary Rehabilitation to Improve Asthma Control­A Randomized Controlled Study (EPRA, Effectiveness of Pulmonary Rehabilitation for Patients with Asthma).

BACKGROUND: Despite the availability of effective pharmaceutical treatment options, many patients with asthma do not manage to control their illness. This randomized trial with a waiting-list control group examined whether a 3-week course of inpatient pulmonary rehabilitation (PR) improves asthma control (primary endpoint) and other secondary endpoints (e.g., quality of life, cardinal symptoms, mental stress). The subsequent observational segment of the study investigated the long-term outcome after PR. METHODS: After approval of the rehabilitation´ by the insurance providers (T0), 412 adults with uncontrolled asthma (Asthma Control Test [ACT] score < 20 points) undergoing rehabilitation were assigned to either the intervention group (IG) or the waiting-list control group (CG). PR commenced 1 month (T1) after randomization in the IG and 5 months after randomization (T3) in the CG. Asthma control and the secondary endpoints were assessed 3 months after PR in the IG (T3) as an intention-to-treat analysis by means of analyses of covariance. Moreover, both groups were observed for a period of 12 months after the end of PR. RESULTS: At T3 the mean ACT score was 15.76 points in the CG, 20.38 points in the IG. The adjusted mean difference of 4.71 points was clinically relevant (95% confidence interval [3.99; 5.43]; effect size, Cohen's d = 1.27). The secondary endpoints also showed clinically relevant effects in favor of the IG. A year after the end of rehabilitation the mean ACT score was 19.00 points, still clinically relevant at 3.54 points higher than when rehabilitation began. Secondary endpoints such as quality of life and cardinal symptoms (dyspnea, cough, expectoration, pain) and self-management showed moderate to large effects. CONCLUSION: The trial showed that a 3-week course of PR leads to clinically relevant improvement in asthma control and secondary endpoints. Patients who do not achieve control of their asthma despite outpatient treatment therefore benefit from rehabilitation.

Long-Term Benefits of Adding a Pedometer to Pulmonary Rehabilitation for COPD: The Randomized Controlled STAR Trial.

Purpose: This Stay Active after Rehabilitation (STAR) study examined the effects of a pedometer-based behavioral intervention for individuals with COPD during three weeks of inpatient pulmonary rehabilitation (PR) on patients' physical activity levels six weeks and six months after PR, including steps (primary outcome), moderate-intensity physical activity, and sedentary time as well as patient quality of life, symptoms, and other psychological and clinical variables. Patients and Methods: Rehabilitation patients with COPD wore a triaxial accelerometer (ActiGraph wGT3X) for seven days two weeks before (T0) as well as six weeks (T3) and six months (T4) after PR. In addition to the three-week inpatient PR (control group, CG), the randomly allocated intervention group (IG) received a brief pedometer-based behavioral intervention with the application of the following behavior-change techniques: performing the behavior, individual goal-setting, self-monitoring, and feedback. The effects were analyzed using analysis of covariance with an intention-to-treat approach. Results: A total of 327 patients (69% male, age: 58 years, FEV1 (%): 53.5, six-minute walk distance: 447.8 m) were randomly allocated to either the IG (n = 167) or CG (n = 160). Although both groups increased their daily steps after PR (IG: MT3-T0 = 1152, CG: MT3-T0 = 745; IG: MT4-T0 = 795, CG: MT4-T0 = 300), the slightly higher increases in daily steps in the IG compared to the CG at T3 (Δ388 steps, d = 0.16) and T4 (Δ458 steps, d = 0.15) were not statistically significant (p > 0.05 for all). Patients in both groups showed moderate to high pre-post-changes in terms of secondary outcomes, but no advantage favoring the IG was found. Conclusion: The results show that adding a pedometer-based behavioral intervention to standard German three-week inpatient PR for COPD patients did not result in more physical activity in terms of steps and moderate-intensity physical activity or less sedentary time. However, both groups (IG and CG) showed remarkably enhanced physical activity levels six weeks and six months after PR, as well as improvements in other secondary outcomes (eg, quality of life).

Impaired Dendritic Cell Homing in COVID-19.

The high mortality of COVID-19 is mostly attributed to acute respiratory distress syndrome (ARDS), whose histopathological correlate is diffuse alveolar damage (DAD). Furthermore, severe COVID-19 is often accompanied by a cytokine storm and a disrupted response of the adaptive immune system. Studies aiming to depict this dysregulation have mostly investigated the peripheral cell count as well as the functionality of immune cells. We investigated the impact of SARS-CoV-2 on antigen-presenting cells using multiplexed immunofluorescence. Similar to MERS-CoV and SARS-CoV, SARS-CoV-2 appears to be impairing the maturation of dendritic cells (DCs). DC maturation involves a switch in surface antigen expression, which enables the cells' homing to lymph nodes and the subsequent activation of T-cells. As quantitative descriptions of the local inflammatory infiltrate are still scarce, we compared the cell population of professional antigen-presenting cells (APC) in the lungs of COVID-19 autopsy cases in different stages of DAD. We found an increased count of myeloid dendritic cells (mDCs) in later stages. Interestingly, mDCs also showed no significant upregulation of maturation markers in DAD-specimens with high viral load. Accumulation of immature mDCs, which are unable to home to lymph nodes, ultimately results in an inadequate T-cell response.

Viral mapping in COVID-19 deceased in the Augsburg autopsy series of the first wave: A multiorgan and multimethodological approach.

BACKGROUND: COVID-19 is only partly understood, and the level of evidence available in terms of pathophysiology, epidemiology, therapy, and long-term outcome remains limited. During the early phase of the pandemic, it was necessary to effectively investigate all aspects of this new disease. Autopsy can be a valuable procedure to investigate the internal organs with special techniques to obtain information on the disease, especially the distribution and type of organ involvement. METHODS: During the first wave of COVID-19 in Germany, autopsies of 19 deceased patients were performed. Besides gross examination, the organs were analyzed with standard histology and polymerase-chain-reaction for SARS-CoV-2. Polymerase chain reaction positive localizations were further analyzed with immunohistochemistry and RNA-in situ hybridization for SARS-CoV-2. RESULTS: Eighteen of 19 patients were found to have died due to COVID-19. Clinically relevant histological changes were only observed in the lungs. Diffuse alveolar damage in considerably different degrees was noted in 18 cases. Other organs, including the central nervous system, did not show specific micromorphological alterations. In terms of SARS-CoV-2 detection, the focus remains on the upper airways and lungs. This is true for both the number of positive samples and the viral load. A highly significant inverse correlation between the stage of diffuse alveolar damage and viral load was found on a case and a sample basis. Mediastinal lymph nodes and fat were also affected by the virus at high frequencies. By contrast, other organs rarely exhibited a viral infection. Moderate to strong correlations between the methods for detecting SARS-CoV-2 were observed for the lungs and for other organs. CONCLUSIONS: The lung is the most affected organ in gross examination, histology and polymerase chain reaction. SARS-CoV-2 detection in other organs did not reveal relevant or specific histological changes. Moreover, we did not find CNS involvement.

An Internet-Based Asthma Self-Management Program Increases Knowledge About Asthma.

BACKGROUND: Asthma education (AE) is associated with reduced hospitalization and disability. We compared the effectiveness of an electronic AE program (eAEP) with a conventional face-to-face AE program (presence-based AEP; pAEP) for asthma knowledge (AK) with regard to self-management. METHODS: A randomized controlled pilot study was conducted in a pulmonary reha- bilitation clinic. AK was determined by means of the Asthma Knowledge Test (AKT). The change in AKT score within each group was calculated with a paired t-test. Group differences were estimated with adjusted linear regression models. RESULTS: In the intervention group (n = 41), the AKT score increased from 41.57 (standard deviation 5.63) at baseline to 45.82 (3.84) after completion of the eAEP (p < 0.001), and again to 47.20 (3.78) after completion of the pAEP (p = 0.046). In the control group (n = 41), the score increased from 41.73 (4.74) at baseline to 45.72 (3.65) after completion of the pAEP (p < 0.001). There was no relevant differ- ence in knowledge gain between the eAEP and the pAEP group after completion of the corresponding educational sessions (p = 0.881). The AKT score was higher in the eAEP group after obligatory participation in pAEP than in the group that only completed the pAEP (p = 0.020). CONCLUSION: An internet-based AEP could help to reduce the knowledge deficits of a large proportion of patients with asthma.

Physical Activity and Sedentary Behaviour Patterns in 326 Persons with COPD before Starting a Pulmonary Rehabilitation: A Cluster Analysis.

This study applies a cluster analysis to identify typical physical activity (PA) and sedentary behaviour (SB) patterns in people with chronic obstructive pulmonary disease (COPD) before starting pulmonary rehabilitation (PR). We implemented an observational design which assessed baseline data of objectively measured PA and SB from the STAR (Stay Active after Rehabilitation) study. A total of 355 persons wore an accelerometer (Actigraph wGT3X) for seven days before the start of their PR. Sociodemographic and disease-related parameters were assessed at the start of PR. We applied cluster analysis and compared clusters applying univariate variance analyses. Data was available for 326 persons (31.6% women; age ø = 58 years). Cluster analysis revealed four movement clusters with distinct PA and SB patterns: Sedentary non-movers (28.5%), sedentary occasional movers (41.7%), sedentary movers (19.6%), and sedentary exercisers (10.1%). The four clusters displayed varying levels of moderate PA before rehabilitation (Ø daily min: 9; 28; 38; 70). Notably, all four clusters displayed considerably long average sedentary time per day (Ø daily minutes: 644; 561; 490; 446). The clusters differed significantly in disease-related parameters of GOLD severity, FEV1, CAT, and 6-Min-Walk-Test. In addition to PA promotion, PR programs should consider the reduction of sedentary behaviour as a valuable goal.

The impact of disease-specific fears on outcome measures of pulmonary rehabilitation in patients with COPD.

Anxiety is a highly prevalent psychological comorbidity in patients with chronic obstructive pulmonary disease (COPD) and has detrimental effects on pulmonary rehabilitation (PR) outcomes. It has been suggested that disease-specific fears could play an even more important role in COPD patients' disease progression. However, little is known about how different disease-specific fears impact COPD. This study examined how different disease-specific fears relate to different PR outcome measures in COPD patients and how these relationships evolve over the course of PR. Before and after a 3-week inpatient PR program, COPD patients (N = 104) underwent a 6-min walking test to measure functional exercise capacity. Disease-specific fears (fear of physical activity, fear of dyspnea, fear of disease progression, fear of social exclusion) were assessed with the COPD-Anxiety-Questionnaire-Revised. Health-related quality of life (HQoL), COPD health status, dyspnea in daily life, depression, and anxiety were measured using validated questionnaires. Multiple regression showed that greater disease-specific fears at the start of PR were associated with worse functional exercise capacity, HQoL, health status, and depression at the start and end of PR (controlling for age, sex, lung function, smoking status, and general anxiety). Patients who showed a stronger decrease in disease-specific fears improved more in PR outcome measures over the course of PR. Furthermore, different disease-specific fears were related to different PR outcome measures. The results show that disease-specific fears are associated with treatment outcome measures, both cross-sectionally and prospectively. Therefore, disease-specific fears should be addressed in COPD patients as they might play a significant role in disease progression.

Impact of Disease-Specific Fears on Pulmonary Rehabilitation Trajectories in Patients with COPD.

Disease-specific fears predict health status in chronic obstructive pulmonary disease (COPD), but their role in pulmonary rehabilitation (PR) remains poorly understood and especially longer-term evaluations are lacking. We therefore investigated changes in disease-specific fears over the course of PR and six months after PR, and investigated associations with PR outcomes (COPD assessment test (CAT) and St. Georges respiratory questionnaire (SGRQ)) in a subset of patients with COPD (n = 146) undergoing a 3-week inpatient PR program as part of the STAR study (Clinicaltrials.gov, ID: NCT02966561). Disease-specific fears as measured with the COPD anxiety questionnaire improved after PR. For fear of dyspnea, fear of physical activity and fear of disease progression, improvements remained significant at six-month follow-up. Patients with higher disease-specific fears at baseline showed elevated symptom burden (CAT and SGRQ Symptom scores), which persisted after PR and at follow-up. Elevated disease-specific fears also resulted in reduced improvements in Quality of Life (SGRQ activity and impact scales) after PR and at follow-up. Finally, improvement in disease-specific fears was associated with improvement in symptom burden and quality of life. Adjustment for potential confounding variables (sex, smoking status, age, lung function, and depressive symptoms) resulted in comparable effects. These findings show the role of disease-specific fears in patients with COPD during PR and highlight the need to target disease-specific fears to further improve the effects of PR.

Baseline health status and setting impacted minimal clinically important differences in COPD: an exploratory study.

OBJECTIVES: Minimal clinically important differences (MCIDs) are used as fixed numbers in the interpretation of clinical trials. Little is known about its dynamics. This study aims to explore the impact of baseline score, study setting, and patient characteristics on health status MCIDs in chronic obstructive pulmonary disease (COPD). STUDY DESIGN AND SETTING: Baseline and follow-up data on the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and St. George's Respiratory Questionnaire (SGRQ) were retrospectively analyzed from pulmonary rehabilitation (PR) and routine clinical practice (RCP). Anchor- and distribution-based MCID estimates were calculated and tested between settings, gender, age, Global initiative for Obstructive Lung Disease (GOLD) classification, comorbidities, and baseline health status. RESULTS: In total, 658 patients were included with 2,299 change score measurements. MCID estimates for improvement and deterioration ranged for all subgroups 0.50-6.30 (CAT), 0.10-0.84 (CCQ), and 0.33-12.86 (SGRQ). Larger MCID estimates for improvement and smaller ones for deterioration were noted in patients with worse baseline health status, females, elderly, GOLD I/II patients, and patients with less comorbidities. Estimates from PR were larger. CONCLUSION: Baseline health status and setting affected MCID estimates of COPD health status questionnaires. Patterns were observed for gender, age, spirometry classification, and comorbidity levels. These outcomes would advocate the need for tailored MCIDs.

Thresholds for clinically important deterioration versus improvement in COPD health status: results from a randomised controlled trial in pulmonary rehabilitation and an observational study during routine clinical practice.

OBJECTIVES: Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease. Preventing deterioration of health status is therefore an important therapy goal. (Minimal) Clinically Important Differences ((M)CIDs) are used to interpret changes observed. It remains unclear whether (M)CIDs are similar for both deterioration and improvement in health status. This study investigates and compares these clinical thresholds for three widely-used questionnaires. DESIGN AND SETTING: Data were retrospectively analysed from an inhouse 3-week pulmonary rehabilitation (PR) randomised controlled trial in the German Klinik Bad Reichenhall (study 1), and observational research in Dutch primary and secondary routine clinical practice (RCP) (study 2). PARTICIPANTS: Patients with COPD aged ≥18 years (study 1) and aged ≥40 years (study 2) without respiratory comorbidities were included for analysis. PRIMARY OUTCOMES: The COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St George's Respiratory Questionnaire (SGRQ) were completed at baseline and at 3, 6 and 12 months. A Global Rating of Change scale was added at follow-up. Anchor-based and distribution-based methods were used to determine clinically relevant thresholds. RESULTS: In total, 451 patients were included from PR and 207 from RCP. MCIDs for deterioration ranged from 1.30 to 4.21 (CAT), from 0.19 to 0.66 (CCQ), and from 2.75 to 7.53 (SGRQ). MCIDs for improvement ranged from -3.78 to -1.53 (CAT), from -0.50 to -0.19 (CCQ), and from -9.20 to -2.76 (SGRQ). Thresholds for moderate improvement versus deterioration ranged from -5.02 to -3.29 vs 3.89 to 8.14 (CAT), from -0.90 to -0.72 vs 0.42 to 1.23 (CCQ), and from -15.85 to -13.63 vs 7.46 to 9.30 (SGRQ). CONCLUSIONS: MCID ranges for improvement and deterioration on the CAT, CCQ and SGRQ were somewhat similar. However, estimates for moderate and large change varied and were inconsistent. Thresholds differed between study settings. TRIAL REGISTRATION NUMBER: Routine Inspiratory Muscle Training within COPD Rehabilitation trial: #DRKS00004609; MCID study: #UMCG201500447.