Single-ventricle
Conditions
Brief 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).
Interventions
DEVICEInspiratory muscle therapy
6 weeks of inspiratory muscle therapy
Sponsors
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise parameters | 6-8 weeks | Peak VO2 and endurance time are the primary outcome measures |
Outcome results
None listed