Cynthia Kleppinger, Dunbar Ivy, Norman Stockbridge, Angela Bates, Stephanie Handler, Usha S. Krishnan, Mary P. Mullen, Delphine Yung, Rachel K. Hopper, Nidhy P. Varghese, Jef Fineman, Eric D. Austin, Catherine M. Avitabile, Grace Freire, Jennifer Clark, Haihao Sun
United States Food and Drug Administration. University of Colorado. Stollery Children’s Hospital. Medical College of Wisconsin. Columbia University Irving Medical Center. Boston Children’s Hospital and Harvard Medical School. University of Washington and Seattle Children’s Hospital. Stanford University. Baylor College of Medicine and Texas Children’s Hospital. UCSF Benioff Children’s Hospital.
United States and Canada
American Association of Pharmaceutical Scientists Journal
AAPS J 2025; 27:
DOI: 10.1208/s12248-025-01098-7
Abstract
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.
Category
Diagnostic Testing for Pulmonary Vascular Disease. Non-invasive Testing
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Fresh (PHresh). Less than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: Yes