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NCT01977222 · ClinicalTrials.gov registry record · NA
Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training
A NA study of Congenital Heart Disease and Single-ventricle, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01977222 is a NA study of Congenital Heart Disease and Single-ventricle that has completed, run by Boston Children's Hospital. The registered enrollment target is 12 participants, below the 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01977222, a NA study of Congenital Heart Disease and Single-ventricle, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation. The "thoracic pump" is a contributor to venous return that has been largely unexplored in patients with Fontan physiology. Inspiratory muscle training can improve the performance of competitive athletes across a range of sports and can improve quality of life and functional capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and possibly by improving peripheral blood flow during exercise. One could surmise that the effects of these changes would be particularly important in the Fontan population. The investigators propose to study the effects of inspiratory muscle training on exercise and pulmonary function parameters in a cohort of adult Fontan patients. The investigators hypothesize that a 12-week program of inspiratory muscle training with an inspiratory impedance threshold device will improve inspiratory muscle strength and endurance, and that this will translate into improved exercise performance in patients with Fontan physiology.
Conditions Studied
Interventions
- DEVICE THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
Study Locations (1)
Massachusetts
- Children's Hospital, Boston - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01977222
The ClinicalTrials.gov registry entry for NCT01977222 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (97% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER is the first listed.
NCT01977222 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01977222 about?
NCT01977222 is a clinical study titled "Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training". Mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation. The "thoracic pump" is a contributor to venous return that has been largely unexplored in patients with Fontan physiolo...
What is the current status of trial NCT01977222?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2013-12. Estimated completion is 2015-03.
What conditions does trial NCT01977222 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Single-ventricle.
What interventions are being tested in trial NCT01977222?
The interventions under investigation include: THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER (DEVICE).
Who is sponsoring clinical trial NCT01977222?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01977222 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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