Congenital Heart DiseaseNCT01977222
Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training
A study testing THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER in people with Congenital Heart Disease and Single Ventricle, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Single Ventricle
- What is being tested?
- THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Fontan physiology
- Undergoing cardiopulmonary stress testing
- Able to complete a previous cardiopulmonary stress test in the preceding 24 months
- Ability to comply with the inspiratory muscle training protocol
- Ability to return for repeat stress testing and pulmonary function testing 12 weeks after enrollment
- Ability to provide informed consent
Who cannot join
- Status post cardiac transplantation
- Current pregnancy or plans to become pregnant within the next 3 months (for females of childbearing potential)
- Active respiratory infection
- Active cigarette smoker
- Baseline oxygen saturation <90% at the previous clinic visit or exercise test
- Forced expired volume in 1 s and/or vital capacity <60% of predicted at the previous exercise test
- Cardiac surgery or catheter-based procedure in the preceding 18 months or planned surgery or catheter-based procedure within the next 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital, Boston
Boston, Massachusetts, 02115
About this study
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
- Congenital Heart Disease, Single Ventricle
- Being tested
- THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERDevice
Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER | Experimental | Not described Receives: Device: THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements.
Measured: Baseline and after 12 weeks of training
Secondary outcomes (2)
Change in Innocor Measurement (Inert Gas Rebreathing Method) of Cardiac Output at Peak Exercise
Measured: 12 weeks
Change in SF-36 Health Survey Score (Physical Component Summary)
The 36-Item Short Form (SF-36) Health Survey is a disease-generic survey of an individual's perceived health status and health-related quality of life. There are eight scaled scores, which are the weighted sums of the questions in their section. Each scale is transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. These eight scales are then used to calculate (using a proprietary formula) two summary scores: the physical component score (PCS), representing the four physical health scales (physical functioning, role physical, bodily pain, general health), and the mental component score (MCS), representing the four mental health scales (mental health, role emotional, vitality, social functioning). Component scores are norm-based with a mean of 50 (standardized to the US population) and a standard deviation of 10.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred Wu, Boston Children's Hospital
- Investigators
- Fred Wu, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977222
- Sponsor's protocol ID
- P00006063
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2013
- Last updated
- 14 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training
- ClinicalTrials.gov ID
- NCT01977222
- Acronym / sponsor ID
- P00006063
- Conditions
- Congenital Heart Disease, Single Ventricle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Posted 14 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER | Experimental | Device: THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age and older
- Fontan physiology
- Undergoing cardiopulmonary stress testing
- Able to complete a previous cardiopulmonary stress test in the preceding 24 months
- Ability to comply with the inspiratory muscle training protocol
Key exclusion criteria (7 listed)
- Status post cardiac transplantation
- Current pregnancy or plans to become pregnant within the next 3 months (for females of childbearing potential)
- Active respiratory infection
- Active cigarette smoker
- Baseline oxygen saturation <90% at the previous clinic visit or exercise test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERSubjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O. | Device | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER |
Primary outcome
Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements.
Time frame: Baseline and after 12 weeks of training
2 secondary outcomes
Change in Innocor Measurement (Inert Gas Rebreathing Method) of Cardiac Output at Peak Exercise
Time frame: 12 weeks
Change in SF-36 Health Survey Score (Physical Component Summary)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Wu, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER in people with Congenital Heart Disease and Single Ventricle, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements. (time frame: Baseline and after 12 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.