Kleppinger Cynthia, Ivy Dunbar, Stockbridge Norman, Bates Angela, Handler Stephanie, Krishnan Usha S, Mullen Mary P, Yung Delphine, Hopper Rachel K, Varghese Nidhy P, Fineman Jeff, Austin Eric D, Avitabile Catherine M, Freire Grace, Clark Jennifer, Sun Haihao
US Food and Drug Administration Silver Spring, Maryland, United States of America.
University of Colorado, Denver, United States of America.
AAPS J. 2025 Jun 27;27(5):114. doi: 10.1208/s12248-025-01098-7.
The six-minute walk test (6MWT) is a common method to assess submaximal exercise capacity in children and adults with pulmonary arterial hypertension (PAH) and other chronic diseases. There is no guideline specifically for 6MWT in children. In this observational pilot study, we evaluated the impact of procedural variations on the outcome of the 6MWT in the real-world clinical setting at pediatric PAH programs. We collected 6MWT data from 33 children with PAH participating in a multicenter, prospective, non-interventional study. Data range/quantiles and standard deviation (SD) were used to describe distribution of the six-minute walk distance (6MWD) and data variability. Levene's test was used to test for heterogeneity of variance with the two sites of similar altitude and their age/height/weight-matched Panama Function Class II participants. We analyzed all 33 eligible participants and their qualified first walks at five centers (A-E) with 6MWD ranges of 420-570, 357-683, 418-481, 400-700, 377-549 m, respectively. Site D performed the 6MWT in a busy hallway and allowed parental/caregiver's cheering, while Site E performed the 6MWT in a secluded area with no parental/caregiver involvement. Mean 6MWD and SD for Sites D and E were 547 (125) and 432 (67.5) meters, respectively (p = 0.03). In conclusion, procedural variations seem to associate with 6MWD data variability. Although interpretation of our results is limited by the small sample size, our findings suggest that standardizing pediatric 6MWT procedures are needed.
六分钟步行试验(6MWT)是评估患有肺动脉高压(PAH)和其他慢性疾病的儿童及成人次最大运动能力的常用方法。目前尚无专门针对儿童6MWT的指南。在这项观察性试点研究中,我们评估了在儿科PAH项目的实际临床环境中,操作流程变化对6MWT结果的影响。我们收集了参与一项多中心、前瞻性、非干预性研究的33名PAH儿童的6MWT数据。数据范围/分位数和标准差(SD)用于描述六分钟步行距离(6MWD)的分布和数据变异性。使用Levene检验来检验海拔相似的两个地点及其年龄/身高/体重匹配的巴拿马功能分级II级参与者的方差齐性。我们分析了五个中心(A - E)的所有33名符合条件的参与者及其合格的首次步行数据,6MWD范围分别为420 - 570、357 - 683、418 - 481、400 - 700、377 - 549米。地点D在繁忙的走廊进行6MWT,并允许家长/照顾者欢呼,而地点E在没有家长/照顾者参与的隐蔽区域进行6MWT。地点D和E的平均6MWD和SD分别为547(125)米和432(67.5)米(p = 0.03)。总之,操作流程变化似乎与6MWD数据变异性相关。尽管我们的结果解释因样本量小而受到限制,但我们的研究结果表明需要规范儿科6MWT程序。