Inspiratory Muscle Therapy in Subjects With Fontan Circulations

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status: Completed

Conditions: Single-ventricle

Treatments: Device: Inspiratory muscle therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03339466

30799-01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Single ventricle physiology status post Fontan palliation

Exclusion criteria

• The presence of a sub-pulmonary ventricle
• Pregnancy or any contraindication to stress testing (e.g., uncontrolled symptomatic arrhythmia, severe systemic ventricular outflow tract obstruction or uncontrolled symptomatic heart failure).
• Height less than 4'11" due to limitations of the cycle ergometer.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Experimental arm - Inspiratory Muscle Training

Experimental group

Description:

Single arm study. All subjects will perform 6-8 weeks of inspiratory muscle therapy with cardiopulmonary stress test (both standard and constant work rate) before and after intervention.

Treatment:

Device: Inspiratory muscle therapy