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

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          Abstract

          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)

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          Most cited references32

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          Susceptibility to exacerbation in chronic obstructive pulmonary disease.

          Although we know that exacerbations are key events in chronic obstructive pulmonary disease (COPD), our understanding of their frequency, determinants, and effects is incomplete. In a large observational cohort, we tested the hypothesis that there is a frequent-exacerbation phenotype of COPD that is independent of disease severity. We analyzed the frequency and associations of exacerbation in 2138 patients enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study. Exacerbations were defined as events that led a care provider to prescribe antibiotics or corticosteroids (or both) or that led to hospitalization (severe exacerbations). Exacerbation frequency was observed over a period of 3 years. Exacerbations became more frequent (and more severe) as the severity of COPD increased; exacerbation rates in the first year of follow-up were 0.85 per person for patients with stage 2 COPD (with stage defined in accordance with Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages), 1.34 for patients with stage 3, and 2.00 for patients with stage 4. Overall, 22% of patients with stage 2 disease, 33% with stage 3, and 47% with stage 4 had frequent exacerbations (two or more in the first year of follow-up). The single best predictor of exacerbations, across all GOLD stages, was a history of exacerbations. The frequent-exacerbation phenotype appeared to be relatively stable over a period of 3 years and could be predicted on the basis of the patient's recall of previous treated events. In addition to its association with more severe disease and prior exacerbations, the phenotype was independently associated with a history of gastroesophageal reflux or heartburn, poorer quality of life, and elevated white-cell count. Although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype. This has implications for the targeting of exacerbation-prevention strategies across the spectrum of disease severity. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00292552.)
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            An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation.

            Pulmonary rehabilitation (PR) has demonstrated physiological, symptom-reducing, psychosocial, and health economic benefits for patients with chronic respiratory diseases, yet it is underutilized worldwide. Insufficient funding, resources, and reimbursement; lack of healthcare professional, payer, and patient awareness and knowledge; and additional patient-related barriers all contribute to the gap between the knowledge of the science and benefits of PR and the actual delivery of PR services to suitable patients.
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              St. George's Respiratory Questionnaire: MCID.

              The SGRQ is a disease-specific measure of health status for use in COPD. A number of methods have been used for estimating its minimum clinically important difference (MCID). These include both expert and patient preference-based estimates. Anchor-based methods have also been used. The calculated MCID from those studies was consistently around 4 units, regardless of assessment method. By contrast, the MCID calculated using distribution-based methods varied across studies and permitted no consistent estimate. All measurements of clinical significance contain sample and measurement error. They also require value judgements, if not about the calculation of the MCID itself then about the anchors used to estimate it. Under these circumstances, greater weight should be placed upon the overall body of evidence for an MCID, rather than one single method. For that reason, estimates of MCID should be used as indicative values. Methods of analysing clinical trial results should reflect this, and use appropriate statistical tests for comparison with the MCID. Treatments for COPD that produced an improvement in SGRQ of the order of 4 units in clinical trials have subsequently found wide acceptance once in clinical practice, so it seems reasonable to expect any new treatment proposed for COPD to produce an advantage over placebo that is not significantly inferior to a 4-unit difference.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J. Med. Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                August 2016
                08 August 2016
                : 18
                : 8
                : e215
                Affiliations
                [1] 1Pulmonary and Critical Care Medicine Section VA Boston Healthcare System Boston, MAUnited States
                [2] 2Harvard Medical School Boston, MAUnited States
                [3] 3Pulmonary & Critical Care Division University of Michigan Health System Ann Arbor, MIUnited States
                [4] 4Department of Family Medicine University of Michigan Ann Arbor, MIUnited States
                [5] 5Center for Clinical Management Research VA Ann Arbor Healthcare System Ann Arbor, MIUnited States
                [6] 6Department of Biostatistics School of Public Health University of Michigan Ann Arbor, MIUnited States
                [7] 7Department of Research and Evaluation Kaiser Permanente Southern California Pasadena, CAUnited States
                [8] 8Pulmonary Medicine Section VA New York Harbor Brooklyn, NYUnited States
                [9] 9Department of Psychiatry University of Michigan Ann Arbor, MIUnited States
                Author notes
                Corresponding Author: Caroline R Richardson caroli@ 123456umich.edu
                Author information
                http://orcid.org/0000-0002-2471-9218
                http://orcid.org/0000-0003-2070-4091
                http://orcid.org/0000-0003-0935-3761
                http://orcid.org/0000-0002-6190-4666
                http://orcid.org/0000-0003-2300-1842
                http://orcid.org/0000-0002-0604-8027
                http://orcid.org/0000-0002-3650-3705
                http://orcid.org/0000-0002-8551-0741
                http://orcid.org/0000-0003-3232-2189
                http://orcid.org/0000-0002-5026-3859
                http://orcid.org/0000-0002-1945-6046
                Article
                v18i8e215
                10.2196/jmir.5622
                4993862
                27502583
                c778879b-c36d-4135-a2e0-54d2206836c3
                ©Marilyn L Moy, Carlos H Martinez, Reema Kadri, Pia Roman, Robert G Holleman, Hyungjin Myra Kim, Huong Q Nguyen, Miriam D Cohen, David E Goodrich, Nicholas D Giardino, Caroline R Richardson. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.08.2016.

                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, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 9 February 2016
                : 10 March 2016
                : 21 April 2016
                : 24 May 2016
                Categories
                Original Paper
                Original Paper

                Medicine
                bronchitis, chronic,emphysema,pulmonary disease, chronic obstructive,quality of life,exercise,motor activity,internet

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