Emotional Distress and Physical Activity Engagement in U.S. Veterans With Chronic Obstructive Pulmonary Disease: A Qualitative Study.

BACKGROUND: Physical activity is recommended as part of guideline-based care for managing chronic obstructive pulmonary disease (COPD) at all stages of the disease. However, physical activity interventions are less effective in individuals with co-occurring emotional distress (i.e., depression and/or anxiety symptoms). Interventions that dually promote improved physical and mental health in COPD are needed. The first step for intervention development is understanding individuals' experience of these factors. PURPOSE: To understand the experience of emotional distress in U.S. Veterans diagnosed with COPD and to explore how emotional distress impacts physical activity engagement. METHODS: Structured interviews informed by the cognitive and behavioral models of psychopathology were conducted with 29 United States Veterans with COPD (89.66% male, age 67.72 ± 6.55 years, 93.10% White) at the VA Boston Healthcare System. Interviews were audio recorded, transcribed, and underwent thematic analysis. RESULTS: Three major themes encapsulating 17 codes emerged through thematic analysis: (i) the experience of emotional distress in Veterans with COPD; (ii) the complex relationship between emotional distress, physical activity engagement, and COPD; (iii) contextual and personal factors. CONCLUSIONS: Veterans' interpretation of their COPD symptoms as unpredictable and uncontrollable and COPD-related physical limitations influenced their experience of emotional distress, while the experience of emotional distress both promoted and deterred physical activity engagement. Veterans were motivated to engage in physical activity despite experiencing emotional distress when they faced a responsibility in daily life. They identified motivational strategies and self-regulation techniques to manage emotional distress and to foster physical activity.

Promoting physical activity is important for maintaining functioning in persons with chronic obstructive pulmonary disease (COPD), but physical activity interventions do not help all individuals. One reason may be the presence of co-occurring clinically significant depression and/or anxiety symptoms (i.e., emotional distress). Behavioral interventions that can address both physical activity and emotional distress at the same time are needed and may translate to improved outcomes. To inform intervention development, the current qualitative study explored the relationship between emotional distress and physical activity engagement, as well as contextual influencers (i.e., social support) in 29 U.S. Veterans with COPD and emotional distress. Participants completed a structured interview guided by the cognitive behavioral model of psychopathology. Three major themes encapsulating 17 codes emerged through thematic analysis: (i) the experience of emotional distress in Veterans with COPD; (ii) the complex relationship between emotional distress, physical activity engagement, and COPD; (iii) contextual and personal factors. The experience of emotional distress both promoted and deterred physical activity. Family, friends, and environmental factors (i.e., seasonal changes) impacted the experience of emotional distress and physical activity engagement. The findings inform intervention development that is patient-centered and dually address physical activity and emotional distress.

Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline.

Background: Despite the known benefits of pulmonary rehabilitation (PR) for patients with chronic respiratory disease, this treatment is underused. Evidence-based guidelines should lead to greater knowledge of the proven benefits of PR, highlight the role of PR in evidence-based health care, and in turn foster referrals to and more effective delivery of PR for people with chronic respiratory disease. Methods: The multidisciplinary panel formulated six research questions addressing PR for specific patient groups (chronic obstructive pulmonary disease [COPD], interstitial lung disease, and pulmonary hypertension) and models for PR delivery (telerehabilitation, maintenance PR). Treatment effects were quantified using systematic reviews. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to formulate clinical recommendations. Recommendations: The panel made the following judgments: strong recommendations for PR for adults with stable COPD (moderate-quality evidence) and after hospitalization for COPD exacerbation (moderate-quality evidence), strong recommendation for PR for adults with interstitial lung disease (moderate-quality evidence), conditional recommendation for PR for adults with pulmonary hypertension (low-quality evidence), strong recommendation for offering the choice of center-based PR or telerehabilitation for patients with chronic respiratory disease (moderate-quality evidence), and conditional recommendation for offering either supervised maintenance PR or usual care after initial PR for adults with COPD (low-quality evidence). Conclusions: These guidelines provide the basis for evidence-based delivery of PR for people with chronic respiratory disease.

Residential radon decay products are associated with cough and phlegm in patients with COPD.

Radon decay products attach to particulate matter (referred to as particle radioactivity, PR) has been shown to be potential to promote airway damage after inhalation. In this study, we investigated associations between PR with respiratory symptoms and health-related quality of life (HRQL) in patients with COPD. 141 male patients with COPD, former smokers, completed the St. George's Respiratory Questionnaire (SGRQ) after up to four 1-week seasonal assessments (N=474) of indoor (home) and ambient (central site) particulate matter ≤ 2.5 µm in diameter (PM2.5) and black carbon (BC). Indoor PR was measured as α-activity (radiation) on PM2.5 filter samples. The ratio of indoor/ambient sulfur in PM2.5 (a ventilation surrogate) was used to estimate α-PR from indoor radon decay. SGRQ responses assessed frequent cough, phlegm, shortness of breath, wheeze, and chest attacks in the past 3 months. Multivariable linear regression with generalized estimating equations accounting for repeated measures was used to explore associations, adjusting for potential confounders. Median (IQR) indoor α-PR was 1.22 (0.62) mBq/m3. We found that there were positive associations between α-PR with cough and phlegm. The strongest associations were with estimated α-PR of indoor origin for cough (31.1 % increase/IQR, 95 %CI: 8.8 %, 57.8 %), and was suggestive for phlegm (13.0 % increase/IQR, 95 %CI: -2.5 %, 31.0 %), similar adjusting for indoor BC or PM2.5. α-PR of indoor origin was positively associated with an increase in SGRQ Symptoms score [1.2 units/IQR; 95 %CI: -0.3, 2.6] that did not meet conventional levels of statistical significance. Our results suggested that exposure to indoor radon decay products measured as particle radioactivity, a common indoor exposure, is associated with cough, and suggestively associated with phlegm and worse HRQL symptoms score in patients with COPD.

Value of Information Analysis of a Web-Based Self-Management Intervention for Chronic Obstructive Pulmonary Disease.

Objective: Technology-based programs can be cost-effective in the management of chronic obstructive pulmonary disease (COPD). However, cost-effectiveness estimates always contain some uncertainty, and decisions based upon them carry some risk. We conducted a value of information (VOI) analysis to estimate the value of additional research of a web-based self-management intervention for COPD to reduce the costs associated with uncertainty. Methods: We used a 10,000-iteration cost-effectiveness model from the health care payer perspective to calculate the expected value of perfect information (EVPI) at the patient- and population-level. An opportunity loss was incurred when the web-based intervention did not produce a greater net monetary benefit than usual care in an iteration. We calculated the probability of opportunity loss and magnitude of opportunity costs as a function of baseline health utility. We aggregated opportunity costs over the projected incident population of inpatient COPD patients over 10 years and estimated it as a function of the willingness-to-pay (WTP) threshold. Costs are in 2022 U.S. Dollars. Results: Opportunity losses were found in 22.7% of the iterations. The EVPIpatient was $78 per patient (95% confidence interval: $75-$82). The probability that the intervention was the optimal strategy varied across baseline health utilities. The EVPIpopulation was $506,666,882 over 10 years for a WTP of $50,000. Conclusions: Research estimated to cost up to $500 million would be warranted to reduce uncertainty. Future research could focus on identifying the impact of baseline health utilities to maximize the cost savings of the intervention. Other considerations for future research priorities include implementation efforts for technology-based interventions.

Depression Symptoms and Physical Activity in Veterans With COPD: Insights From a Web-Based, Pedometer-Mediated Physical Activity Intervention.

BACKGROUND: Depression is known to limit physical activity (PA) among individuals with chronic obstructive pulmonary disease (COPD). However, whether and how depression influences the effectiveness of PA interventions is unknown. PURPOSE: The study examined the association between baseline depression symptoms and change in daily step count and whether group assignment to a web-based, pedometer-mediated PA intervention moderated the association between baseline depression symptoms and change in daily step count. METHODS: Secondary analysis included two cohorts of U.S. Veterans with COPD (n = 212; 97% male; mean age 69 ± 8 years) assessed at baseline and 3 months. Cohorts 1 and 2 were randomly assigned to the same PA intervention (n = 111) or a control group (n = 101). Multivariate regressions tested the main effects of baseline depression symptoms (BDI-II total and cognitive-affective and somatic subscales) on change in daily steps, as well as the interaction between baseline BDI-II and subscales and group assignment on change in daily steps. RESULTS: Greater BDI-II total score (B = -31.8, SE = 14.48, p = .030) and somatic subscale scores (B = -99.82, SE = 35.76, p = .006) were associated with less improvement in daily step count. There was a significant interaction between baseline cognitive-affective subscale and the intervention predicting change in daily step count (B = -88.56, SE = 42.31, p = .038). When cognitive-affective subscale scores were ≥1 SD above the mean, the intervention was no longer associated with an increase in daily step count (p = .585). CONCLUSIONS: Depression should be routinely assessed and targeted as part of PA promotion efforts.

United States (U.S.) Veterans have high rates of chronic obstructive pulmonary disease (COPD), a progressive lung disease that causes shortness of breath. Promoting physical activity (PA) is an important component to the management of COPD resulting in improved outcomes. Technology-based interventions (i.e., pedometers, websites) are effective at increasing PA in persons with COPD. However, depression symptoms, such as low mood and motivation, may influence their effectiveness. This secondary data analysis examined whether depression symptoms were related to improvement in daily step count. Two cohorts of U.S. Veterans were randomized to either a web-based, pedometer-mediated PA intervention (i.e., pedometer, goal setting and feedback, education and online community) or a control group (i.e., pedometer only or usual care). Daily step count was assessed at baseline and at 3 months. Across both groups, greater overall depression symptoms and greater bodily symptoms of depression (i.e., fatigue) were associated with less improvement in daily step count. Veterans with greater cognitive-affective symptoms of depression (i.e., low mood, loss of interest, or pleasure) who were assigned to the intervention group showed no improvement in daily step count compared with controls. Results highlight the importance of detecting and treating depression as part of PA interventions.

The Impact of Depression and Exercise Self-Efficacy on Benefits of Pulmonary Rehabilitation in Veterans with COPD.

Pulmonary rehabilitation (PR) improves health-related quality of life (HRQoL) and exercise capacity. Little is known about the impact of depression symptoms and exercise self-efficacy on improvements in these key PR outcomes. This study examined the impact of baseline depression status and change in depression symptoms (Beck Depression Inventory-II [BDI-II] score) over the course of PR on change in HRQoL assessed by the Chronic Respiratory Disease Questionnaire-Self Reported (CRQ-SR) and exercise capacity as measured by the 6-Minute Walk Test (6MWT). We also examined whether baseline exercise self-efficacy moderated the association between baseline depression symptoms and change in these key PR outcomes. We studied 112 US veterans (aged 70.38 ± 8.49 years) with chronic obstructive pulmonary disease (COPD) who completed PR consisting of twice-weekly 2-hour classes for 18 sessions. Depressed (BDI-II >13) and nondepressed (BDI-II ≤13) patients at baseline demonstrated comparable and significant improvement in CRQ-SR total score, subscales, and 6MWT. Greater reduction in depression over the course of treatment was significantly associated with greater improvement in CRQ-SR total score and the following subscales: fatigue, mastery, and emotional function. Change in depression did not predict change in 6MWT distance. Baseline exercise self-efficacy moderated the association between baseline depression symptoms and change in CRQ-SR fatigue. Specifically, when baseline exercise self-efficacy was <30.4, greater baseline depression was associated with less improvement in CRQ-SR fatigue. When baseline self-efficacy was >152.0, greater baseline depression was associated with greater improvement in CRQ-SR fatigue. PR programs should address mood and confidence to exercise given their impact on key PR outcomes.

Modification of associations between indoor particulate matter and systemic inflammation in individuals with COPD.

RATIONALE: Little is known about personal characteristics and systemic responses to particulate pollution in patients with COPD. OBJECTIVES: Assess whether diabetes, obesity, statins and non-steroidal anti-inflammatory medications (NSAIDs) modify associations between indoor black carbon (BC) and fine particulate matter ≤2.5 µm in diameter (PM2.5) on systemic inflammation and endothelial activation. METHODS: 144 individuals with COPD without current smoking and without major in-home combustion sources were recruited at Veterans Affairs Boston Healthcare System. PM2.5 and BC were measured in each participant's home seasonally for a week (up to 4 times; 482 observations) and plasma biomarkers of systemic inflammation [C-reactive protein (CRP); interleukin-6 (IL-6)] and endothelial activation [soluble vascular adhesion molecule-1 (sVCAM-1)] measured. Linear mixed effects regression with a random intercept was used, and effect modification assessed with multiplicative interaction terms and stratum specific estimates. RESULTS: Median (25%ile, 75%ile) indoor BC and PM2.5 were 0.6 (0.5,0.7) µg/m3 and 6.8 (4.8,10.4) µg/m3, respectively. Although p-values for effect modification were not statistically significant, there were positive associations (%-increase/interquartile range; 95% CI) between CRP and BC greater among non-statin (18.8%; 3.6-36.3) than statin users (11.1%; 2.1-20.9). There were also positive associations greater among non-statin users between PM2.5 and CRP. For IL-6, associations with BC and PM2.5 were also greater among non-statin users. Associations between CRP and BC were greater (20.3%; 4.5-38.5) in persons with diabetes than without diabetes (10.3%; 0.92-20.6) with similar effects of PM2.5. There were no consistent associations that differed based on obesity. Effect modification was not observed for NSAID use, or with any factor considered with sVCAM-1. CONCLUSIONS: Associations between indoor BC and PM2.5 and CRP were greater in patients with diabetes and those not taking statins, and with IL-6 if not taking statins. These results suggest that these characteristics may modify the systemic response to indoor BC and PM2.5 in persons with COPD.

Predictors of Outpatient Pulmonary Rehabilitation Uptake, Adherence, Completion, and Treatment Response Among Male U.S. Veterans With Chronic Obstructive Pulmonary Disease.

OBJECTIVE: To examine predictors of uptake (never start), adherence (drop out), and completion of pulmonary rehabilitation (PR), as well as PR treatment response based on minimal clinically important difference (MCID) on the 6-minute walk test (6MWT) distance and Chronic Respiratory Questionnaire-Self-Report (CRQ-SR). DESIGN: Retrospective, cohort study. SETTING: Veterans Health Administration. PARTICIPANTS: U.S. veterans with chronic obstructive pulmonary disease (COPD) (N=253) referred to PR between 2010 and 2018. INTERVENTIONS: Outpatient PR program. MAIN OUTCOME MEASURES: Participants completed baseline (time 1) measures of depression (Beck Depression Inventory-II), health-related quality of life (CRQ-SR), self-efficacy (Exercise Self-Regulatory Efficacy Scale [Ex-SRES]), and COPD knowledge. Exercise capacity was assessed with the 6MWT. Participants who completed all 18 sessions of PR repeated assessments (time 2). Logistic regression models examined predictors of uptake, adherence, and completion of PR as well as treatment response based on MCID. RESULTS: Participants were referred to PR with 24.90% never starting, 28.90% dropping out, and 46.20% completing. No differences emerged between never starters and dropouts. Having a history of any cancer increased the likelihood of completing PR (vs never starting; odds ratio [OR], 3.18; P=.003). Greater CRQ-SR dyspnea score, indicating less dyspnea, was associated with increased likelihood of completing PR (OR, 1.12; P=.006). Past smoking compared with current smoking was associated with increased likelihood of completion (OR, 3.89; P≤.002). Those without a history of alcohol use disorder had increased likelihood of completing PR (OR, 2.23; P=.048). Greater baseline 6MWT distance was associated with lower likelihood of achieving MCID in 6MWT (OR, 0.99; P<.001). Greater Ex-SRES was associated with decreased likelihood of achieving 6MWT MCID (OR, 0.98; P=.023). CONCLUSIONS: Findings suggest that early psychoeducation on dyspnea management and smoking and alcohol cessation may increase completion of PR.

Pain in Veterans with COPD: relationship with physical activity and exercise capacity.

BACKGROUND: Pain is a common but underappreciated symptom experienced by people with Chronic Obstructive Pulmonary Disease (COPD). The relationships between pain and physical activity (PA) and exercise capacity are poorly understood. METHODS: This retrospective secondary analysis includes three cohorts of Veterans with COPD who participated in longitudinal studies evaluating PA and exercise capacity with objective measures of daily step counts and 6-min walk test (6MWT) distance, respectively. Pain was assessed using the bodily pain domain of the Veterans RAND-36. In two cohorts, participants were randomly assigned to a web-based, pedometer-mediated PA intervention which has previously been demonstrated to improve PA. RESULTS: Three-hundred and seventy-three (373) unique study participants were included in this analysis. Eighty-three percent (n = 311) of the population reported at least mild pain and/or at least a little bit of interference due to pain at baseline. Cross-sectionally, greater bodily pain was associated with lower 6MWT distance (ß = 0.51; 95% CI 0.20, 0.82; p = 0.0013). Longitudinally, worsening bodily pain was associated with a decline in 6MWT distance (ß = 0.30; 95% CI 0.03, 0.58; p = 0.0312). There was no association between baseline bodily pain and baseline daily step counts, baseline bodily pain and change in PA, or change in bodily pain and change in PA. Compared to usual care, our PA intervention improved bodily pain scores (ß = 6.17; 95% CI 1.84, 10.45; p = 0.0054). Bodily pain scores did not affect the impact of the intervention on daily step counts. CONCLUSION: Pain is highly prevalent and significantly associated with lower exercise capacity among Veterans with COPD. Worsening pain co-occurred with decline in exercise capacity but not PA. Our intervention reduced pain, although pain did not affect the impact of the intervention on PA.

Sociodemographic Characteristics and Physical Activity in Patients with COPD: A 3-Month Cohort Study.

Decreased physical activity (PA) is associated with morbidity and mortality in COPD patients. In this secondary analysis of data from a 12-week longitudinal study, we describe factors associated with PA in COPD. Participants completed the Physical Activity Checklist (PAC) daily for a 7- to 8-day period. PA was measured monthly using the Physical Activity Scale for the Elderly (PASE). At three different time points, daily step count was measured for one week with an Omron HJ-720ITC pedometer. The 35 participants were primarily male (94%) and White (91%), with an average age of 66.5 years and FEV1 44.9% predicted. Common activities reported on the PAC were walking (93%), preparing a meal (89%), and traveling by vehicle (96%). PA measured by both PASE score (p = 0.01) and average daily step count (p = 0.04) decreased during follow-up. In repeated measures multivariable modeling, participants living with others had a higher daily step count (ß = 942 steps, p = 0.01) and better PASE scores (ß = 46.4, p < 0.001). Older age was associated with decreased step count (ß = -77 steps, p < 0.001) whereas White race was associated with lower PASE scores (ß = -55.4, p < 0.001) compared to non-White race. Other demographic factors, quality of life, and medications were not associated with PA. A better understanding of the role of social networks and social support may help develop interventions to improve PA in COPD.

Exploring Tai Chi Exercise and Mind-Body Breathing in Patients with COPD in a Randomized Controlled Feasibility Trial.

In this pilot feasibility randomized controlled trial, participants with moderate to severe COPD were randomized to a 12-week tai chi or MBB intervention. Participants were assessed at baseline, 12 weeks, and 24 weeks. Feasibility, as assessed by intervention adherence, was the primary outcome. We also estimated preliminary between-group differences in COPD symptoms and health-related quality of life, cognitive-emotional function, and functional status across three timepoints: baseline, 12, and 24 weeks. A total of 92 participants were randomized 2:1 to tai chi (n = 61) or MBB (n = 31). The overall group adherence in the first 12 weeks was 62% in tai chi and 75% in MBB. From baseline to 12 weeks, tai chi demonstrated greater improvements in depressive symptoms (Cohen's d effect size (ES) = -.53; adj mean diff = -2.31 [-5.7, 1.07]), 6-minute walk test distance (ES = .47; adj mean diff = 62.04 [2.85, 121.22]), social support (ES = .36; adj mean diff = .19 [-0.11, 0.49]) and chair stand (ES = .44; adj mean diff = .91 [-0.05, 1.86]). Only improvements in social support were maintained at 24-week follow-up. Tai chi and MBB are feasible for individuals with COPD. Preliminary effects suggest that while our mindful breathing intervention may not be sufficient to impact outcomes, tai chi may result in short-term benefits in mood, social support and functional capacity. More work is needed to better understand mindful breathing for COPD and to examine methods for maintaining improvements from tai chi over time.Supplemental data for this article is available online at https://doi.org/10.1080/15412555.2021.1928037 .

Can Technology-Based Physical Activity Programs for Chronic Obstructive Pulmonary Disease Be Cost-Effective?

Objective: To evaluate the cost-effectiveness of a technology-based physical activity (PA) intervention for chronic obstructive pulmonary disease (COPD). Design: A secondary data analysis was performed from a randomized controlled trial in COPD of an activity monitor alone or an activity monitor plus a web-based PA intervention. Models estimated cost per quality-adjusted life year (QALY) and incremental cost-effectiveness ratios (ICERs) compared with usual care. Results: The estimated ICER for both groups was below the willingness-to-pay threshold of $50,000/QALY (activity monitor alone = $10,437/QALY; website plus activity monitor intervention = $13,065/QALY). A probabilistic simulation estimated 76% of the activity monitor-alone group and 78% of the intervention group simulations to be cost-effective. Conclusion(s): Both the activity monitor-alone group and the activity monitor plus website group were cost-effective at the base case by using conventional willingness-to-pay thresholds. Further research would benefit from a more direct estimate of health utilities and downstream health care costs. Clinical Trials.gov NCT01102777.

A web-based physical activity intervention benefits persons with low self-efficacy in COPD: results from a randomized controlled trial.

Promoting physical activity (PA) is of top priority in chronic obstructive pulmonary disease (COPD). This study examines the influence of an internet-delivered intervention on the relationship between exercise self-efficacy and changes in PA, physical health, and exercise capacity in COPD. 112 U.S. Veterans with COPD were randomized to either a comparison (pedometer alone) or an intervention group (pedometer plus access to an internet-mediated PA intervention). There was a significant interaction between baseline exercise self-efficacy and randomization group on change in PA. In the comparison group, there was a significant relationship between higher baseline exercise self-efficacy and greater change in PA, whereas in the intervention group, improvements in PA were independent of level of baseline self-efficacy. Similar patterns were found with physical health and exercise capacity as outcomes. The use of an internet-mediated intervention significantly benefited persons with COPD who had low baseline self-efficacy to increase PA and physical health.Clinical trial registration The randomized clinical trial was registered on ClinicalTrials.gov (NCT01772082).

Physical activity in COPD: Minimal clinically important difference for medical events.

Estimates of the minimal clinically important difference (MCID) for physical activity (PA) in chronic obstructive pulmonary disease (COPD) are needed. The objective is to provide an anchor-based estimate of the MCID for daily step count. PA was promoted in persons with COPD using a pedometer (Omron HJ-720ITC) alone or a pedometer plus interactive website for 3 months. Participants wore the pedometer daily and received phone calls monthly to ascertain medical events. Medical events were counted when a participant self-reported that he/she had (1) worsening of breathing, (2) change to breathing medications, (3) medical care from an emergency room for any reason, or (4) hospitalization for any reason. Generalized linear regression models assessed daily step count as change at the end of study and averaged over the 15, 31, or 61 days centered on the event, in those with an event compared to those without one. All categories of events carried equal weight in the analyses. We studied 93 persons, 46 of whom had an event. Participants who experienced an event had a decrease of 1086 (95% confidence interval (CI): -2124 to -48) or 887 (95% CI: -2030 to 257) steps/day in the pedometer plus website or pedometer alone groups, respectively, compared to those without one. In the days centered on an event, participants who had an event experienced a decrease of 882-983 steps/day (pedometer plus website) or a decrease of 351-495 steps/day (pedometer alone), compared to those without one. The MCID for PA in COPD ranges from 350 steps/day to 1100 steps/day.

Indoor black carbon and biomarkers of systemic inflammation and endothelial activation in COPD patients.

RATIONALE: Evidence linking traffic-related particle exposure to systemic effects in chronic obstructive lung disease (COPD) patients is limited. OBJECTIVES: Assess relationships between indoor black carbon (BC), a tracer of traffic-related particles, and plasma biomarkers of systemic inflammation and endothelial activation. METHODS: BC was measured by reflectance in fine particle samples over a mean of 7.6 days in homes of 85 COPD patients up to 4 times seasonally over a year. After the completion of sampling, plasma C-reactive protein (CRP), interleukin-6 (IL-6), and soluble vascular adhesion molecule-1 (sVCAM-1) were measured. Current smokers and homes with major sources of BC were excluded; therefore, indoor BC was primarily a measure of infiltrated outdoor BC. Mixed effects regression models with a random intercept for each participant were used to assess BC effects at different times (1-9 days before phlebotomy) and in the multi-day sample. RESULTS: Measured median BC was 0.19 µg/m3 (interquartile range, IQR=0.22 µg/m3). Adjusting for season, race, age, BMI, heart disease, diabetes, ambient temperature, relative humidity, a recent cold or similar illness, and blood draw time, there was a positive relationship between BC and CRP. The largest effect size was for BC averaged over the previous seven days (11.8% increase in CRP per IQR; 95%CI = 1.8-22.9). Effects were greatest among non-statin users and persons with diabetes. There were positive effects of BC on IL-6 only in non-statin users. There were no associations with sVCAM-1. CONCLUSIONS: These results demonstrate exposure-response relationships between indoor BC with biomarkers of systemic inflammation in COPD patients, with stronger relationships in persons not using statins and with diabetes.

Applying the pragmatic-explanatory continuum indicator summary to the implementation of a physical activity coaching trial in chronic obstructive pulmonary disease.

BACKGROUND: Observational studies show that physical inactivity is associated with worse outcomes in chronic obstructive pulmonary disease (COPD). Despite practice guidelines recommending regular physical activity (PA), there are no large-scale experimental studies to confirm that patients at high risk for COPD exacerbations can increase their PA and consequently, have improved outcomes. PURPOSE: The purpose of this case study is to describe the use of a widely accepted pragmatic trials framework for the design and implementation of a pragmatic clinical trial (PCT) of PA coaching for COPD in a real-world setting. METHOD: The aim of the trial was to determine the effectiveness of a 12-month PA coaching intervention (Walk On!) compared to standard care for 2,707 patients at high risk for COPD exacerbations from a large integrated health care system. The descriptions of our implementation experiences are anchored within the pragmatic-explanatory continuum indicator summary (PRECIS-2) framework. DISCUSSION: Facilitators of PCT implementation include early and ongoing engagement and support of multiple stakeholders including patients, health system leaders, administrators, physician champions, and frontline clinicians, an organizational/setting that prioritizes positive lifestyle behaviors, and a flexible intervention that allows for individualization. Pragmatic challenges include reliance on electronic data that are not complete or available in real-time for patient identification, timing of outreach may not synchronize with patients' readiness for change, and high turnover of clinical staff drawn from the existing workforce. DISCUSSION: PRECIS-2 is a useful guide for organizing decisions about study designs and implementation approaches to help diverse stakeholders recognize the compromises between internal and external validity with those decisions.

Long-Term Effects of an Internet-Mediated Pedometer-Based Walking Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.

BACKGROUND: Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed. OBJECTIVE: We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months. METHODS: Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George's Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey. RESULTS: Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P<.001), but approached zero in months 8-12. Within the intervention group, mean 76.7% (SD 29.5) of 366 days had valid step-count data, which decreased over the months of study (P<.001). Mean number of log-ins to the website each month also significantly decreased over the months of study (P<.001). The online community forum was used at least once during the study by 83.8% (129/154) of participants. Responses to questions assessing participants' goal commitment and intervention engagement were not significantly different at 12 months compared to 4 months. CONCLUSIONS: An Internet-mediated, pedometer-based PA intervention, although efficacious at 4 months, does not maintain improvements in HRQL and daily step counts at 12 months. Waning pedometer adherence and website engagement by the intervention group were observed. Future efforts should focus on improving features of PA interventions to promote long-term behavior change and sustain engagement in PA. CLINICALTRIAL: Clinicaltrials.gov NCT01102777; https://clinicaltrials.gov/ct2/show/NCT01102777 (Archived by WebCite at http://www.webcitation.org/6iyNP9KUC).

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease.

BACKGROUND: Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. METHODS/DESIGN: This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. DISCUSSION: Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George's Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220).Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. TRIAL REGISTRATION: Clinical Trials.gov NCT01102777.

Reasons persons with COPD do not walk and relationship with daily step count.

BACKGROUND: Physical activity (PA) is significantly reduced in persons with COPD. Assessing reasons why persons with COPD do not engage in PA can guide development of effective interventions to promote PA. METHODS: We queried 102 participants with stable COPD about disease-related and general reasons why they do not walk more. The StepWatch Activity Monitor (Orthocare Innovations, Mountlake Terrace, WA, USA) assessed daily step count, a direct measure of PA. Regression models assessed daily step count by response categories, adjusting for age and FEV1 % predicted. RESULTS: Subjects had mean age 72 ± 8 years and mean FEV1 1.48 ± 0.55 L (52 ± 19% predicted). COPD-related worries of becoming short of breath (SOB), needing to use inhalers, or oxygen level becoming low were endorsed by 31, 14, and 12 subjects, respectively. Controlling for age and FEV1% predicted, those who worried about becoming SOB walked an average of 1,329 fewer steps per day than those who did not worry (p = 0.020). Those who worried about needing to use inhalers walked an average of 1,806 fewer steps per day than those who did not worry (p = 0.016). Subjects who were the most motivated and confident walked significantly more than those who were the least motivated and confident. CONCLUSIONS: Presence of COPD-related reasons and lower motivation and confidence are associated with lower daily step count. Management of dyspnea and education about medication use during exercise, and strategies to increase motivation and confidence could facilitate walking in COPD.