Respiratory Muscle WeaknessNCT06580808
Inspiratory Training in Children After Fontan
A study testing Fontan Training Group in people with Respiratory Muscle Weakness, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle Weakness
- What is being tested?
- Fontan Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Sep 2017to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 8 to 12 years;
- Both sexes;
- No history of other heart disease;
- No history of lung and musculoskeletal diseases;
- \>1 year post-operative Fontan Surgery;
- Clinically stable;
- Absence of serious arrhythmias;
- Medical clearance to participate in the study; The legal guardian has agreed to participate in the research and the child has consented
Who cannot join
- Musculoskeletal alterations;
- Patients with neurological sequelae;
- Patients with genetic syndromes associated with cognitive or psychiatric disorders;
- History of perioperative arrhythmias;
- Patients with uncontrolled heart failure;
- Recent angina;
Show all 11Show fewer
- Severe arrhythmia;
- Hemoptysis;
- Pulmonary hypertension;
- Diaphragmatic plication;
- Moderate to severe asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inspiratory Muscle Training in Children After Fontan Surgery.
This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate. Some children in the late postoperative period of Fontan surgery will be randomized to a group of inspiratory muscle training that will last for 2 months. Children after Fontan surgery will be evaluated twice, once at the beginning and again after two months of follow-up.
Read the detailed description
This study aims to evaluate physical capacity through cardiopulmonary testing, submaximal physical capacity testing by the 6-minute walk test, respiratory capacity by spirometry, respiratory muscle strength by manovacuometry, diaphragmatic mobility by ultrasound, quality of life by the AUQEI questionnaire. There are three groups, a healthy control group, a Fontan control group and a Fontan intervention group. The intervention will be done by respiratory muscle training using the Power Breath device.
- Conditions
- Respiratory Muscle Weakness
- Being tested
- Fontan Training Group
- Keywords
- congenital heart disease, Fontan procedure, rehabilitation, physiotherapy, inspiratory muscle training
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fontan Training GroupOther
The Fonta training group consisted of 14 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months of inspiratory muscle training to assess the results of these in postoperative patients and what changes the training could bring. The training was performed with the Power Breath device, the carda was quantified at 40% of the force exerted at maximum inspiratory pressure by manovacuometry. The patient was asked to perform 3 sets of 20 repetitions twice over the course of 7 days of the week. Monitoring was done in person and virtually, and the carda was increased according to the evaluator's perception of the ease of the exercise or if the patient reported it to be easy. The training lasted 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group consisted of 18 healthy children. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed to assess the results of these tests in patients without previous illnesses. |
| Fontan Training Group | Active comparator | The Fonta training group consisted of 14 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months of inspiratory muscle training to assess the results of these in postoperative patients and what changes the training could bring. The training was performed with the Power Breath device, the carda was quantified at 40% of the force exerted at maximum inspiratory pressure by manovacuometry. The patient was asked to perform 3 sets of 20 repetitions twice over the course of 7 days of the week. Monitoring was done in person and virtually, and the carda was increased according to the evaluator's perception of the ease of the exercise or if the patient reported it to be easy. The training lasted 2 months. Receives: Other: Fontan Training Group |
| Fonta Control Group | No intervention | The Fonta Control Group consisted of 13 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months to assess the results of these tests in postoperative patients and whether there was any normal behavior. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the diaphragm muscle
The mobility and thickness of the diaphragm muscle were assessed using ultrasound in M mode. Both variables were analyzed during spontaneous, relaxed breathing in terms of both tidal volume and deep breathing at vital capacity. Muscle mobility was examined along the right and left mid-axillary and parasternal lines with volunteers in both the supine and sitting positions. Muscle thickness was measured while the patients were in the supine position along the mid-axillary lines during both natural, relaxed and deep breathing. Measurements were taken in centimeters, with the largest value selected from at least three reproducible measurements.
Measured: Baseline to 2 months
Secondary outcomes (5)
Respiratory muscle strength
Respiratory muscle strength was measured using maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) with a digital manometer calibrated beforehand. The MIP was determined by the maximal inspiratory effort from the residual volume (RV), and the MEP was determined by the maximal expiratory effort from the total lung capacity (TLC). At least three reproducible maneuvers were performed, with the largest value used unless it did not exceed the previous value by more than 20%.
Measured: Baseline to 2 months
Lung function test
Pulmonary volume and capacity were evaluated using the spirometer protocol as recommended by the American Thoracic Society guidelines. For spirometry, at least three acceptable and reproducible maneuvers at each stage were performed using encouragement and positive reinforcement to obtain maximum values. Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the FEV1/FVC ratio were studied, and the predicted values were calculated from previously reported equations
Measured: Baseline to 2 months
Six-minute walk test
A submaximal analysis of physical capacity was conducted using the six-minute walk test (6MWT), following the protocol of the American Thoracic Society[16]. The patients were instructed to walk as quickly as possible without running for six minutes, while the distance covered was recorded. Breaks during the walk were allowed if needed. The data analyzed included the distance covered in meters, heart rate, respiratory rate, peripheral oxygen saturation, blood pressure, and the Modified Borg Scale for Fatigue. These measurements were taken at rest one minute before the test, immediately after the test, two minutes after the test if there was an interruption, and five minutes after the test.
Measured: Baseline to 2 months
Change in quality of life measurement
The evaluation of quality of life was conducted using the Self-imaginary Questionnaire on Children\'s Quality of Life (Autoquestionnaire Qualité de Vie Enfant Imagé). This scale consists of closed questions about the point of view for children aged 4 to 12 years, and their answers are directed toward \'very happy\', \'happy\', \'unhappy\', or \'very unhappy\', supported by an image of a child in these emotional states. The survey included 26 analysis items related to socialization, family relationships, activities, health, isolation, and other functions. The items were divided into factors such as autonomy, leisure, functions, family, and the legal value of the answers. The sum of all the questions generates a score with a maximum of 78. Scores less than 48 are considered to indicate a loss in quality of life. The questionnaire was validated and translated by Assumpçao et al.
Measured: Baseline to 2 months
Improvement exercise tolerance and functional capacity (peak VO2)
Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 and Predicted Peak VO2 (%). After the training program, an increase in the peak VO2(mL/kg/min) value between 10 to 15% is expected in relation to the baseline value.
Measured: Baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start27 Sep 2017
- Primary completion13 Jan 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscle WeaknessStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the Fontan group were randomized into the Fontan Training Group (FTG) and Fontan Control Group. The FTG performed inspiratory muscle training with the Power Breth device with an initial load of 40% of the maximum inspiratory pressure obtained by measuring the maximum inspiratory pressure by manovacuometry. The training lasted 2 months. The patient was asked to perform the training every day with 3 series of 20 breaths. The training was monitored in person and remotely by videoconference; the load was increased gradually when it was perceived that it was already easy or reported by the child.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo B Jatene, Manager, Study director, University of Sao PauloJoao Bruno PD Silveira, Execution, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580808
- Sponsor's protocol ID
- 38501214.8.0000.0068
- Status last verified
- Sep 2017
- First submitted
- 16 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If any researcher has any questions about the research or wants to replicate it, I am available to clarify them. If any agency or entity has any questions about the results, they can be made available based on their confidentiality and ethical responsibility to be reanalyzed and reproduced.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Children After Fontan Surgery.
- ClinicalTrials.gov ID
- NCT06580808
- Acronym / sponsor ID
- 38501214.8.0000.0068
- Conditions
- Respiratory Muscle Weakness
- Keywords
- congenital heart disease, Fontan procedure, rehabilitation, physiotherapy, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate. Some children in the late postoperative period of Fontan surgery will be randomized to a group of inspiratory muscle training that will last for 2 months. Children after Fontan surgery will be evaluated twice, once at the beginning and again after two months of follow-up.
Detailed description
This study aims to evaluate physical capacity through cardiopulmonary testing, submaximal physical capacity testing by the 6-minute walk test, respiratory capacity by spirometry, respiratory muscle strength by manovacuometry, diaphragmatic mobility by ultrasound, quality of life by the AUQEI questionnaire. There are three groups, a healthy control group, a Fontan control group and a Fontan intervention group. The intervention will be done by respiratory muscle training using the Power Breath device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients in the Fontan group were randomized into the Fontan Training Group (FTG) and Fontan Control Group. The FTG performed inspiratory muscle training with the Power Breth device with an initial load of 40% of the maximum inspiratory pressure obtained by measuring the maximum inspiratory pressure by manovacuometry. The training lasted 2 months. The patient was asked to perform the training every day with 3 series of 20 breaths. The training was monitored in person and remotely by videoconference; the load was increased gradually when it was perceived that it was already easy or reported by the child.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group consisted of 18 healthy children. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed to assess the results of these tests in patients without previous illnesses. |
| Fontan Training Group | Active comparator | Other: Fontan Training GroupThe Fonta training group consisted of 14 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months of inspiratory muscle training to assess the results of these in postoperative patients and what changes the training could bring. The training was performed with the Power Breath device, the carda was quantified at 40% of the force exerted at maximum inspiratory pressure by manovacuometry. The patient was asked to perform 3 sets of 20 repetitions twice over the course of 7 days of the week. Monitoring was done in person and virtually, and the carda was increased according to the evaluator's perception of the ease of the exercise or if the patient reported it to be easy. The training lasted 2 months. |
| Fonta Control Group | No intervention | –The Fonta Control Group consisted of 13 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months to assess the results of these tests in postoperative patients and whether there was any normal behavior. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 8 to 12 years;
- Both sexes;
- No history of other heart disease;
- No history of lung and musculoskeletal diseases;
- \>1 year post-operative Fontan Surgery;
Key exclusion criteria (11 listed)
- Musculoskeletal alterations;
- Patients with neurological sequelae;
- Patients with genetic syndromes associated with cognitive or psychiatric disorders;
- History of perioperative arrhythmias;
- Patients with uncontrolled heart failure;
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 |
|---|---|---|
| Fontan Training GroupThe Fonta training group consisted of 14 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months of inspiratory muscle training to assess the results of these in postoperative patients and what changes the training could bring. The training was performed with the Power Breath device, the carda was quantified at 40% of the force exerted at maximum inspiratory pressure by manovacuometry. The patient was asked to perform 3 sets of 20 repetitions twice over the course of 7 days of the week. Monitoring was done in person and virtually, and the carda was increased according to the evaluator's perception of the ease of the exercise or if the patient reported it to be easy. The training lasted 2 months. | Other | Fontan Training Group |
Primary outcome
Assessment of the diaphragm muscle
Time frame: Baseline to 2 months
The mobility and thickness of the diaphragm muscle were assessed using ultrasound in M mode. Both variables were analyzed during spontaneous, relaxed breathing in terms of both tidal volume and deep breathing at vital capacity. Muscle mobility was examined along the right and left mid-axillary and parasternal lines with volunteers in both the supine and sitting positions. Muscle thickness was measured while the patients were in the supine position along the mid-axillary lines during both natural, relaxed and deep breathing. Measurements were taken in centimeters, with the largest value selected from at least three reproducible measurements.
5 secondary outcomes
Respiratory muscle strength
Time frame: Baseline to 2 months
Lung function test
Time frame: Baseline to 2 months
Six-minute walk test
Time frame: Baseline to 2 months
Change in quality of life measurement
Time frame: Baseline to 2 months
Improvement exercise tolerance and functional capacity (peak VO2)
Time frame: Baseline to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: Yes. If any researcher has any questions about the research or wants to replicate it, I am available to clarify them. If any agency or entity has any questions about the results, they can be made available based on their confidentiality and ethical responsibility to be reanalyzed and reproduced.
Related trials for Respiratory Muscle Weakness
RecruitingObservational study
Developing New Ways to Detect Respiratory Impairment Early in ALS
Amyotrophic Lateral Sclerosis (ALS)
Not yet recruiting
Effects of Therapeutic Exercise With and Without Nerve Stimulation on Dysphonia in Post Thyroidectomy Patients
Post-Thyroidectomy Dysphonia
Enrolling by invitation
Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.
Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness
Not yet recruiting
Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Patients
Respiratory Muscle Weakness, Mechanical Ventilation Weaning
Not yet recruiting
Respiratory Muscle Strength Training to Prevent Respiratory Muscle Weakness in Adults Newly Diagnosed With Breast Cancer
Breast Cancer
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.
Marcelo B Jatene, Manager study director
University of Sao Paulo
Joao Bruno PD Silveira, Execution principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fontan Training Group in people with Respiratory Muscle Weakness, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 8 inclusion and 11 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 30 Aug 2024. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of the diaphragm muscle (time frame: Baseline to 2 months). 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 30 Aug 2024.