Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Congenital Heart Disease and Single-ventricle, sponsored by Boston Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01977222 record still lists
NCT01977222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01977222's enrollment target sits among peer trials
12 62nd of 63 higher than 2 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Fontan Fitness Trial
RECRUITING · NA
-
Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery
RECRUITING · NA
-
The Sequencing for Detection in Congenital Heart Disease (SD-CHD) Study
RECRUITING · NA
-
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
RECRUITING · NA
-
A Study of Hemodynamic Cardiopulmonary Exercise for CHD
RECRUITING · NA
-
Ventripoint Single Ventricle Study
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia