NCT03339466

Inspiratory Muscle Therapy in Subjects With Fontan Circulations

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Single-ventricle

Interventions

Type	Name	Description
DEVICE	Inspiratory muscle therapy	6 weeks of inspiratory muscle therapy

Timeline

• Start date: 2016-01-29
• Primary completion: 2016-08-24
• Completion: 2017-08-31
• First posted: 2017-11-13
• Last updated: 2024-01-29