Heart FailureNCT02600000
Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure
A study testing Myocardial scintigraphy, Cardiopulmonary test and AVD-Glittre Test in people with Heart Failure, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Heart failure (HF) is configured major problem for public health in the country. Affected individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of the sympathetic myocardial activity, among others. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Myocardial scintigraphy, Cardiopulmonary test and AVD-Glittre Test
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Dec 2020
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Heart Failure;
- Lower left ventricular ejection fraction 45% (LVEF <45%) assessed by simple and recent echocardiogram;
- Functional Class II and III by the New York Heart Association (NYHA)
- Clinically stable;
- Ex-smokers over five years;
- Maximal inspiratory pressure (MIP) <70% of predicted;
- Forced expiratory volume/Forced vital capacity (FEV1 / FVC) > 70% of predicted;
Who cannot join
- Unstable angina;
- Myocardial infarction and heart surgery up to three months before the survey;
- Chronic respiratory diseases;
- Hemodynamic instability;
- Trauma recent face, nausea and vomiting.
- Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises;
- Psychological and / or cognitive impairments that restrict them to respond to questionnaires;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Physiology laboratory and cardiopulmonary physiotherapy
Recife, Pernambuco, 50670-901
Jessica C Leite, graduate, +55 83 988667323, jesewev@gmail.com
About this study
Official title: Effectiveness of Inspiratory Muscle Training Associated With a Cardiac Rehabilitation Program in Sympathetic Activity and Functional Capacity in Patients With Heart Failure: a Randomized Clinical Trial
Heart failure (HF) is configured major problem for public health in the country. Affected individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of the sympathetic myocardial activity, among others. In relation to the treatment of patients with heart failure with symptoms mentioned above a great alternative is the implantation of cardiac rehabilitation programs, these programs can also be associated with other muscle training measures, among these there is inspiratory muscle training (IMT), as the weakness of these muscles is rather found in this population and this directly related to signs and symptoms. OBJECTIVE: To evaluate the efficacy of inspiratory muscle training associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity and maximal and submaximal functional capacity of patients with HF between 21-60 years. METHODOLOGY: This is a clinical trial, controlled, randomized, double-blind being developed in partnership with the Department of Physical Therapy, Federal University of Pernambuco (UFPE) and the Hospital das Clinicas (HC) of Pernambuco, whose patients will be accrued on the Recife's main referral centers in caring for patients with heart failure. Patients will undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and digital Manovacuometry) as well as on the functional capacity (Ergospirometry), cardiac innervation (myocardial scintigraphy), mobility and diaphragm thickness (ultrasound) and quality of life. After the evaluation will be randomly allocated into two groups: The control group will perform cardiac rehabilitation associated with the Sham of IMT, and the experimental group cardiac rehabilitation associated with the IMT at 30% of maximal inspiratory pressure. The intervention will last three months for both groups and after this phase patients will be submitted again to the assessment tools. EXPECTED RESULTS: To clarify the association between physical exercise associated with specific respiratory training in modulating the autonomic nervous system of patients with HF and what the relationship with reflected cardiorespiratory fitness in maximal and submaximal functional capacity.
- Conditions
- Heart Failure
- Being tested
- Myocardial scintigraphy, Cardiopulmonary test, AVD-Glittre Test, Diaphragm ultrasound
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial scintigraphyRadiation
Myocardial scintigraphy with Iodo123-Metaiodobenzylguanidine (MIBG) to assess the Sympathetic myocardial activity
Cardiopulmonary testDevice
Assessment of maximal functional capacity
AVD-Glittre TestDevice
Evaluation of submaximal functional capacity after inspiratory muscle training.
Diaphragm ultrasoundDevice
Evaluation of thickness and diaphragmatic mobility
| Study group | Role | What they receive |
|---|---|---|
| Sympathetic myocardial activity after IMT | Experimental | Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity of patients with HF Receives: Radiation: Myocardial scintigraphy |
| Maximal functional capacity after IMT | Experimental | Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the maximal functional capacity of patients with HF Receives: Device: Cardiopulmonary test |
| submaximal functional capacity after IMT | Experimental | Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the submaximal functional capacity of patients with HF Receives: Device: AVD-Glittre Test |
| Thickness and mobility of the diaphragm after IMT | Experimental | Assess the impact of Inspiratory Muscle Training in combination with a cardiac rehabilitation program on the thickness and mobility of the diaphragm in patients with heart failure. Receives: Device: Diaphragm ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenergic tone of the heart muscle
Measured by the integrity and activity of the sympathetic nervous pre synaptic terminals.
Measured: Change from Baseline and Three months after
Change from Functional capacity
Measured by cardiopulmonary exercise testing
Measured: Change from Baseline and Three months after
Secondary outcomes (3)
Change from Submaximal functional capacity
Measured by Glittre Test
Measured: Change from Baseline and Three months after
Mobility of the diaphragm
Reviewed from the ultrasound
Measured: Change from Baseline and Three months after
Diaphragm thickness
Reviewed from the ultrasound
Measured: Change from Baseline and Three months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jéssica Costa Leite, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600000
- Sponsor's protocol ID
- 38572614.1.3001.5192
- Status last verified
- Oct 2019
- First submitted
- 4 Nov 2015
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leite JC, Brandao DC, Brandao SCS, Fuzari HKB, Vidal TM, Frutuoso J, Remigio MI, de Araujo BTS, Campos SL, Dornelas de Andrade A. Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):519. doi: 10.1186/s13063-020-04363-6.
PubMed 32532283
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inspiratory Muscle Training Associated With a Cardiac Rehabilitation Program in Sympathetic Activity and Functional Capacity in Patients With Heart Failure: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02600000
- Acronym / sponsor ID
- 38572614.1.3001.5192
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Nov 2015 (estimated)
- 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.
Heart failure (HF) is configured major problem for public health in the country. Affected individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of the sympathetic myocardial activity, among others. In relation to the treatment of patients with heart failure with symptoms mentioned above a great alternative is the implantation of cardiac rehabilitation programs, these programs can also be associated with other muscle training measures, among these there is inspiratory muscle training (IMT), as the weakness of these muscles is rather found in this population and this directly related to signs and symptoms. OBJECTIVE: To evaluate the efficacy of inspiratory muscle training associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity and maximal and submaximal functional capacity of patients with HF between 21-60 years. METHODOLOGY: This is a clinical trial, controlled, randomized, double-blind being developed in partnership with the Department of Physical Therapy, Federal University of Pernambuco (UFPE) and the Hospital das Clinicas (HC) of Pernambuco, whose patients will be accrued on the Recife's main referral centers in caring for patients with heart failure. Patients will undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and digital Manovacuometry) as well as on the functional capacity (Ergospirometry), cardiac innervation (myocardial scintigraphy), mobility and diaphragm thickness (ultrasound) and quality of life. After the evaluation will be randomly allocated into two groups: The control group will perform cardiac rehabilitation associated with the Sham of IMT, and the experimental group cardiac rehabilitation associated with the IMT at 30% of maximal inspiratory pressure. The intervention will last three months for both groups and after this phase patients will be submitted again to the assessment tools. EXPECTED RESULTS: To clarify the association between physical exercise associated with specific respiratory training in modulating the autonomic nervous system of patients with HF and what the relationship with reflected cardiorespiratory fitness in maximal and submaximal functional capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sympathetic myocardial activity after IMT | Experimental | Radiation: Myocardial scintigraphyEvaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity of patients with HF |
| Maximal functional capacity after IMT | Experimental | Device: Cardiopulmonary testEvaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the maximal functional capacity of patients with HF |
| submaximal functional capacity after IMT | Experimental | Device: AVD-Glittre TestEvaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the submaximal functional capacity of patients with HF |
| Thickness and mobility of the diaphragm after IMT | Experimental | Device: Diaphragm ultrasoundAssess the impact of Inspiratory Muscle Training in combination with a cardiac rehabilitation program on the thickness and mobility of the diaphragm in patients with heart failure. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Heart Failure;
- Lower left ventricular ejection fraction 45% (LVEF <45%) assessed by simple and recent echocardiogram;
- Functional Class II and III by the New York Heart Association (NYHA)
- Clinically stable;
- Ex-smokers over five years;
Key exclusion criteria (7 listed)
- Unstable angina;
- Myocardial infarction and heart surgery up to three months before the survey;
- Chronic respiratory diseases;
- Hemodynamic instability;
- Trauma recent face, nausea and vomiting.
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 |
|---|---|---|
| Myocardial scintigraphyMyocardial scintigraphy with Iodo123-Metaiodobenzylguanidine (MIBG) to assess the Sympathetic myocardial activity | Radiation | Sympathetic myocardial activity after IMT |
| Cardiopulmonary testAssessment of maximal functional capacity | Device | Maximal functional capacity after IMT |
| AVD-Glittre TestEvaluation of submaximal functional capacity after inspiratory muscle training. | Device | submaximal functional capacity after IMT |
| Diaphragm ultrasoundEvaluation of thickness and diaphragmatic mobility | Device | Thickness and mobility of the diaphragm after IMT |
Primary outcome
Adrenergic tone of the heart muscle
Time frame: Change from Baseline and Three months after
Measured by the integrity and activity of the sympathetic nervous pre synaptic terminals.
Change from Functional capacity
Time frame: Change from Baseline and Three months after
Measured by cardiopulmonary exercise testing
3 secondary outcomes
Change from Submaximal functional capacity
Time frame: Change from Baseline and Three months after
Mobility of the diaphragm
Time frame: Change from Baseline and Three months after
Diaphragm thickness
Time frame: Change from Baseline and Three months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Derived from this study: PubMed 32532283Leite JC, Brandao DC, Brandao SCS, Fuzari HKB, Vidal TM, Frutuoso J, Remigio MI, de Araujo BTS, Campos SL, Dornelas de Andrade A. Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):519. doi: 10.1186/s13063-020-04363-6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myocardial scintigraphy, Cardiopulmonary test and AVD-Glittre Test in people with Heart Failure, run by Universidade Federal de Pernambuco 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 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: status not confirmed, as of the sponsor's last update on 30 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniella C Brandão, Doctor (+55 81 998036255, daniellacunha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adrenergic tone of the heart muscle (time frame: Change from Baseline and Three months after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600000, which also lists 1 linked publication.
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 Oct 2019.