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However, clinical trial data are lacking due to many constraints. One major limitation is the lack of relevant trial endpoints reflective of hemodynamics or functional status in patients in whom standard exercise testing is impractical, unreliable, or not reproducible. The Kids Mod PAH trial (Mono\u2010 vs. Duo Therapy for Pediatric Pulmonary Arterial Hypertension) is an ongoing multicenter, Phase III, randomized, open\u2010label, pragmatic trial to compare the safety and efficacy of first\u2010line combination therapy (sildenafil and bosentan) to first\u2010line monotherapy (sildenafil alone) in 100 pediatric patients with PH across North America. Investigators will measure participants\u2019 physical activity with a research\u2010grade, wrist\u2010worn actigraphy device at multiple time points as an exploratory secondary outcome. Vector magnitude counts per minute and activity intensity will be compared between the treatment arms. By directly and noninvasively measuring physical activity in the ambulatory setting, we aim to identify a novel, simple, inexpensive, and highly reproducible approach for quantitative assessment of exercise tolerance in pediatric PH. These data will increase the field's understanding of the effect of pulmonary vasodilator treatment on daily activity \u2013 a quantitative measure of functional status and wellbeing in pediatric PH and a potential primary outcome for future clinical trials in children with cardiopulmonary disorders.<\/jats:p>","DOI":"10.1002\/pul2.12339","type":"journal-article","created":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T16:04:47Z","timestamp":1709913887000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Actigraphy methodology in the Kids Mod PAH trial: Physical activity as a functional endpoint in pediatric clinical trials"],"prefix":"10.1002","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2354-5447","authenticated-orcid":false,"given":"Catherine M.","family":"Avitabile","sequence":"first","affiliation":[{"name":"Division of Cardiology University of Pennsylvania Children's Hospital of 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