Anna R Hemnes1, Luke G Silverman-Lloyd2, Shi Huang3, Grant MacKinnon4, Jeffrey Annis5, Carolyn S Whitmore5, Ravinder Mallugari5, Rashundra N Oggs5, Rezzan Hekmat5, Rongzi Shan6, Pauline P Huynh6, Chang Yu3, Seth S Martin6, Michael J Blaha6, Evan L Brittain7. 1. Division of Allergy Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN. 2. University of California, San Francisco School of Medicine, San Francisco, CA. 3. Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN. 4. Vanderbilt University School of Medicine, Nashville, TN. 5. Division of Cardiovascular Medicine and Vanderbilt Translational and Clinical Cardiovascular Research Center, Nashville, TN. 6. Division of Cardiology and Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins Hospital, Baltimore, MD. 7. Division of Cardiovascular Medicine and Vanderbilt Translational and Clinical Cardiovascular Research Center, Nashville, TN. Electronic address: evan.brittain@vumc.org.
Abstract
BACKGROUND: Supervised exercise training improves outcomes in patients with pulmonary arterial hypertension (PAH). The effect of an unsupervised activity intervention has not been tested. RESEARCH QUESTION: Can a text-based mobile health intervention increase step counts in patients with PAH? STUDY DESIGN AND METHODS: We performed a randomized, parallel arm, single-blind clinical trial. We randomized patients to usual care or a text message-based intervention for 12 weeks. The intervention arm received three automated text messages per day with real-time step count updates and encouraging messages rooted in behavioral change theory. Individual step targets increased by 20% every 4 weeks. The primary end point was mean week 12 step counts. Secondary end points included the 6-min walk test, quality of life, right ventricular function, and body composition. RESULTS: Among 42 randomized participants, the change in raw steps between baseline and week 12 was higher in the intervention group (1,409 steps [interquartile range, -32 to 2,220] vs -149 steps [interquartile range, -1,010 to 735]; P = .02), which persisted after adjustment for age, sex, baseline step counts, and functional class (model estimated difference, 1,250 steps; P = .03). The intervention arm took a higher average number of steps on all days between days 9 and 84 (P < .05, all days). There was no difference in week 12 six-minute walk distance. Analysis of secondary end points suggested improvements in the emPHasis-10 score (adjusted change, -4.2; P = .046), a reduction in visceral fat volume (adjusted change, -170 mL; P = .023), and nearly significant improvement in tricuspid annular plane systolic excursion (model estimated difference, 1.2 mm; P = .051). INTERPRETATION: This study demonstrated the feasibility of an automated text message-based intervention to increase physical activity in patients with PAH. Additional studies are warranted to examine the effect of the intervention on clinical outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No. NCT03069716; URL: www.clinicaltrials.gov.
BACKGROUND: Supervised exercise training improves outcomes in patients with pulmonary arterial hypertension (PAH). The effect of an unsupervised activity intervention has not been tested. RESEARCH QUESTION: Can a text-based mobile health intervention increase step counts in patients with PAH? STUDY DESIGN AND METHODS: We performed a randomized, parallel arm, single-blind clinical trial. We randomized patients to usual care or a text message-based intervention for 12 weeks. The intervention arm received three automated text messages per day with real-time step count updates and encouraging messages rooted in behavioral change theory. Individual step targets increased by 20% every 4 weeks. The primary end point was mean week 12 step counts. Secondary end points included the 6-min walk test, quality of life, right ventricular function, and body composition. RESULTS: Among 42 randomized participants, the change in raw steps between baseline and week 12 was higher in the intervention group (1,409 steps [interquartile range, -32 to 2,220] vs -149 steps [interquartile range, -1,010 to 735]; P = .02), which persisted after adjustment for age, sex, baseline step counts, and functional class (model estimated difference, 1,250 steps; P = .03). The intervention arm took a higher average number of steps on all days between days 9 and 84 (P < .05, all days). There was no difference in week 12 six-minute walk distance. Analysis of secondary end points suggested improvements in the emPHasis-10 score (adjusted change, -4.2; P = .046), a reduction in visceral fat volume (adjusted change, -170 mL; P = .023), and nearly significant improvement in tricuspid annular plane systolic excursion (model estimated difference, 1.2 mm; P = .051). INTERPRETATION: This study demonstrated the feasibility of an automated text message-based intervention to increase physical activity in patients with PAH. Additional studies are warranted to examine the effect of the intervention on clinical outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No. NCT03069716; URL: www.clinicaltrials.gov.
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