Inspiratory Muscle Therapy in Subjects With Fontan Circulations

Single-ventricle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339466
• Other study ID #: 30799-01
• Status: Completed
• Phase: N/A
• Start date: January 29, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: January 2024
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 31, 2017
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Single-ventricle
• Univentricular Heart

Intervention

Device:
• Inspiratory muscle therapy
6 weeks of inspiratory muscle therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise parameters	Peak VO2 and endurance time are the primary outcome measures	6-8 weeks