An interventional study of Inspiratory muscle therapy in Single-ventricle, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Not applicable, Interventional, and Treatment
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).
86 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
This study's enrollment of 7 is below the median of 28 across 44 interventional studies indexed under Univentricular Heart.
Browse Univentricular Heart studies →Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center is the lead sponsor of 67 studies on the registry; 1 is open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Single ventricle physiology status post Fontan palliation
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Inspiratory muscle therapy
6 weeks of inspiratory muscle therapy
Also known as: No other interventions. Subjects will serve as their own control; single arm study.
Exercise parameters
Peak VO2 and endurance time are the primary outcome measures
Time frame: 6-8 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2016 to primary completion in Aug 2016, 6 months.
Of 20 interventional studies with no phase under Univentricular Heart, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 63. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center