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Clinical Trial Summary

Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF). The investigators hypothesized that enhanced respiratory muscle function via inspiratory muscle training (IMT) would improve performance on cardiopulmonary exercise stress testing (CPET).


Clinical Trial Description

Adult Fontan subjects were recruited from 2 academic medical centers. Following characterization of pulmonary function and functional class, CPET was performed using incremental and constant work rate protocols. Subjects performed 6-8 weeks of IMT using a handheld inspiratory loading device (Threshold®, Philips); both exercise tests were then repeated. Patient-centered outcome data were collected before and after IMT (RAND-36 assessment and New York Heart Association (NYHA) functional class). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03339466
Study type Interventional
Source Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Contact
Status Completed
Phase N/A
Start date January 29, 2016
Completion date August 31, 2017

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