Inspiratory Muscle Therapy in Subjects With Fontan Circulations

Single-ventricle Clinical Trial

Official title: A Pilot Study of Inspiratory Muscle Function and the Effects of Inspiratory Muscle Training in Subjects With Fontan Physiology

Status Completed

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). ;

Related Conditions & MeSH terms

• Respiratory Aspiration
• Single-ventricle
• Univentricular Heart

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