Liem R I, Baynard T, Hsu L L, Garofano R, Green N S, Hankins J S, Ness K K, Rodeghier M, Radom-Aizik S
Division of Hematology, Oncology & Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 East Chicago Avenue, Box 30, Chicago, IL, 60611, USA.
Integrative Physiology Laboratory, University of Illinois at Chicago, 1640 West Roosevelt Road, Chicago, IL, 60608, USA.
Contemp Clin Trials Commun. 2020 Oct 9;20:100668. doi: 10.1016/j.conctc.2020.100668. eCollection 2020 Dec.
The impact of sickle cell anemia (SCA) and its complications on physical functioning and cardiopulmonary/aerobic fitness in affected individuals is significant. Although limited data support the safety of maximal cardiopulmonary exercise testing (CPET) for children and adults with SCA, the safety of submaximal moderate and high intensity, and longer duration, exercise in this population is not clear. The Sickle Cell Pro-Inflammatory Response to Interval Testing Study (SPRINTS) is a multicenter, randomized, prospective trial. SPRINTS leverages unique collaborations between investigators in pediatric hematology and exercise science to evaluate the impact of exercise intensity on the acute phase inflammatory response to exercise and changes in airway dynamics in children and young adults with SCA. Here we describe the study design and methodological strategies employed in SPRINTS, including an exercise challenge that mimics real-life patterns of childhood physical activity, characterized by multiple moderate and high intensity brief bouts of exercise interspersed with rest periods. Primary outcomes comprise pre- and post-exercise biomarkers of inflammation and endothelial dysfunction and spirometry. Secondary outcomes include assessment of physical activity and functioning, genomic studies and near-infrared spectroscopy measurements to assess tissue oxygenation status during exercise. SPRINTS aims to enroll 70 subjects with SCA and 70 matched, healthy controls. We anticipate that data from SPRINTS will address gaps in our understanding of exercise responses and safety in SCA and support the future development of evidence-based, exercise prescription guidelines in this population.
镰状细胞贫血（SCA）及其并发症对患者身体功能以及心肺/有氧适能的影响颇为显著。尽管仅有有限的数据支持对患有SCA的儿童和成人进行最大心肺运动测试（CPET）的安全性，但该人群进行次最大强度的中等强度和高强度、持续时间更长的运动的安全性尚不清楚。镰状细胞对间歇测试的促炎反应研究（SPRINTS）是一项多中心、随机、前瞻性试验。SPRINTS利用儿科血液学和运动科学研究人员之间的独特合作，来评估运动强度对患有SCA的儿童和年轻人运动急性期炎症反应以及气道动力学变化的影响。在此，我们描述了SPRINTS中所采用的研究设计和方法策略，包括一项模拟儿童实际身体活动模式的运动挑战，其特点是多次中等强度和高强度的短暂运动回合穿插着休息时间。主要结局包括运动前后炎症和内皮功能障碍的生物标志物以及肺功能测定。次要结局包括身体活动和功能评估、基因组研究以及近红外光谱测量，以评估运动期间的组织氧合状态。SPRINTS旨在招募70名患有SCA的受试者和70名匹配的健康对照。我们预计，SPRINTS的数据将填补我们对SCA运动反应和安全性理解上的空白，并支持该人群未来基于证据的运动处方指南的制定。
