Effect of Physical Activity Coaching on Acute Care and Survival Among Patients With Chronic Obstructive Pulmonary Disease: A Pragmatic Randomized Clinical Trial

Abstract

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 = 1358) or SC (n = 1349). 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, 0.92-1.28; P = .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, 0.65-1.10; P = .21) and death (OR, 0.62; 95% CI, 0.35-1.11; P = .11). More WO participants reported engaging in PA compared with SC (47.4% [152 of 321] vs 30.7% [414 of 1349]; P < .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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Nguyen reported receiving grants from the Patient-Centered Outcomes Research Institute (PCORI). Dr Moy reported receiving personal fees from AstraZeneca. Dr Fan reported receiving grants from PCORI, Department of Veterans Affairs, National Institutes of Health, and Firland Foundation. Dr Gould reported receiving grants from PCORI. Dr Towner reported receiving grants from PCORI, Gilead, ViiV Healthcare, and Merck. Dr Xiang reported receiving grants from PCORI. No other disclosures were reported.

Figures

Figure.. CONSORT Patient Flow

CONSORT indicates Consolidated Standards of Reporting Trials; COPD, chronic obstructive pulmonary disease; EMRs, electronic medical records; and KP, Kaiser Permanente.