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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03339466
Other study ID # 30799-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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