A Pilot Study of Inspiratory Muscle Function and the Effects of Inspiratory Muscle Training in Subjects With Fontan Physiology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 7
- Primary Endpoint
- Exercise parameters
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Experimental arm - Inspiratory Muscle Training
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.
Intervention: Inspiratory muscle therapy (Device)
Outcomes
Primary Outcomes
Exercise parameters
Time Frame: 6-8 weeks
Peak VO2 and endurance time are the primary outcome measures
Secondary Outcomes
No secondary outcomes reported
Investigators
Priya Pillutla
Physician Specialist
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center