Inspiratory Muscle Therapy in Subjects With Fontan Circulations

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center7 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Single-ventricle

Interventions

Inspiratory muscle therapyDEVICE

6 weeks of inspiratory muscle therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Exercise parameters

Peak VO2 and endurance time are the primary outcome measures

Time frame: 6-8 weeks

Data from ClinicalTrials.gov

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