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Effect of physical activity coaching on acute care and survival among patients with chronic obstructive pulmonary disease: a pragmatic randomized clinical trial [with consumer summary]
Nguyen HQ, Moy ML, Liu I-LA, Fan VS, Gould MK, Desai SA, Towner WJ, Yuen G, Lee JS, Park SJ, Xiang AH
JAMA Network Open 2019 Aug;2(8):e199657
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

IMPORTANCE: While observational studies show that physical inactivity is associated with worse outcomes in chronic obstructive pulmonary disease (COPD), there are no population-based trials to date testing the effectiveness of physical activity (PA) interventions to reduce acute care use or improve survival. OBJECTIVE: To evaluate the long-term effectiveness of a community-based PA coaching intervention in patients with COPD. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic randomized clinical trial with preconsent randomization to the 12-month Walk On! (WO) intervention or standard care (SC). Enrollment occurred from July 1, 2015, to July 31, 2017; follow-up ended in July 2018. The setting was Kaiser Permanente Southern California sites. Participants were patients 40 years or older who had any COPD-related acute care use in the previous 12 months; only patients assigned to WO were approached for consent to participate in intervention activities. INTERVENTIONS: The WO intervention included collaborative monitoring of PA step counts, semiautomated step goal recommendations, individualized reinforcement, and peer/family support. Standard COPD care could include referrals to pulmonary rehabilitation. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite binary measure of all-cause hospitalizations, observation stays, emergency department visits, and death using adjusted logistic regression in the 12 months after randomization. Secondary outcomes included self-reported PA, COPD-related acute care use, symptoms, quality of life, and cardiometabolic markers. RESULTS: All 2707 eligible patients (baseline mean (SD) age, 72 (10) years; 53.7% female; 74.3% of white race/ethnicity; and baseline mean (SD) percent forced expiratory volume in the first second of expiration predicted, 61.0 (22.5)) were randomly assigned to WO (n = 1,358) or SC (n = 1,349). The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio (OR) 1.09; 95% CI 0.92 to 1.28; p = 0.33) or in the individual outcomes. Prespecified, as-treated analyses compared outcomes between all SC and 321 WO patients who participated in any intervention activities (23.6% (321 of 1358) uptake). The as-treated, propensity score-weighted model showed nonsignificant positive estimates in favor of WO participants compared with SC on all-cause hospitalizations (OR 0.84; 95% CI 0.65 to 1.10; p = 0.21) and death (OR 0.62; 95% CI 0.35 to 1.11; p = 0.11). More WO participants reported engaging in PA compared with SC (47.4% (152 of 321) versus 30.7% (414 of 1349); p < 0.001) and had improvements in the Patient-Reported Outcomes Measurement Information System 10 physical health domain at 6 months. There were no group differences in other secondary outcomes. CONCLUSIONS AND RELEVANCE: Participation in a PA coaching program by patients with a history of COPD exacerbations was insufficient to effect improvements in acute care use or survival in the primary analysis. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02478359.

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