Congestive Heart FailureCardioBreathNCT06139653
CardioBreathApp vs IMT in Heart Failure
A study testing Moment 1: IMT. Moment 2 CardioBreath. and Moment 1: CardioBreath and moment 2: IMT. in people with Congestive Heart Failure, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Heart failure (HF) is a systemic clinical syndrome defined as cardiac dysfunction, which causes inadequate blood supply to meet metabolic needs. One of the most expressive markers of HF is neurologic exacerbation, with expected sympathetic hyperactivation, increased activity of the renin-angiotensin-aldosterone system… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Moment 1: IMT. Moment 2 CardioBreath. and Moment 1: CardioBreath and moment 2: IMT.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2023to 31 Jan 2025
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive CHF patients in treatment at the outpatient clinic (Institute of Cardiology)
- Of both sexes
- Aged between 40 and 70 years
- And ejection fraction (EF) reduced (<40%)
- Who have access to a mobile device with access to Internet.
Who cannot join
- active smoking
- BMI <30
- Diagnosis of sleep apnea
- Heart failure of congenital origin
- Valve disease.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cardiology Institute of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Therapeutic Effects of CardioBreath Aplication Versus Inspiratory Muscle Training (IMT) on Vagal Cardiac Modulation, Pulse Wave Velocity Maximal Respiratory Pressures in Heart Failure Patients: Cross-over Randomized Control Trial
Heart failure (HF) is a systemic clinical syndrome defined as cardiac dysfunction, which causes inadequate blood supply to meet metabolic needs. One of the most expressive markers of HF is neurologic exacerbation, with expected sympathetic hyperactivation, increased activity of the renin-angiotensin-aldosterone system and elevation of vasopressin levels. These changes compensate the low cardiac output in the onset of ventricular dysfunction ensure a long term high blood perfusion pressure,though aggravate this dysfunction and contributes to the HF progression. There are evidences ofthe therapeutic effects of respiratory exercise techniques for HF patients. However, it demands new data for larger prescription and employment of these kind of exercises. Advanced technologies allowed the elaboration of the application for slow breathing CardioBreath. So far, it requires the possibility of comparison of their effects versus widely validated Inspiratory Muscle Trainig (IMT) on respiratory and cardiovascular outcomes in order to elucidate their specific benefits. In this way compare CardioBreath ® App versus IMT through a crossover randomized clinical trial design may elucidate the response effects of these interventions in these patients.
Read the detailed description
The impact of pulmonary, ventilatory and cardiovascular impairment in patients with congestive heart failure (CHF) highlights the therapeutic relevance of breathing exercises for these functions. In addition, other benefits such as lowering blood pressure,increased cardiac vagal modulation, improved vascular function and psychosocial handling (anxiety, depression and stress) may be expected. Inspiratory Muscle Training (IMT) and slow yoga breathing are widely endorsed as beneficial by a large amount of evidence. The newly developed app CardioBreath ® is based on a breathing technique of yoga (ujjayi pranayama) through respiratory rates (RR) slower than the user's spontaneous RR, in a set of strategies with pedagogical prescription, guidance and monitoring of this type of exercises. This study aims to compare IMT exercises with those of the CardioBreath ® application on , strength respiratory muscle (manuvacuometry), cardiac vagal modulation (heart rate variability), arterial stiffness (heart rate wave velocity) and diaphragm thickness in CHF patients after their hospital discharge in Institute of Cardiology of Rio Grande do Sul. Methods: Crossover randomized control trial will recruit post-discharge CHF patients who will be evaluated through, Finometer system (HR and BP variability/cardiac vagal modulation), Arterial Stiffness (oscillometric method), for indexes of central arterial pressure, velocity pulse waveform (large artery stiffness) and Aix 75 (small artery stiffness), Respiratory Muscle Strength by Manovacuometry and Diaphragm Thickness by ultrasound. Patients will be randomized to two orders of intervention Group 1- Moment 1 TMI and Moment 2 CardioBreath App Group 2- Moment 1 CardioBreath App and Moment 2 TMI. The interventions will face-to-face assistance once a week for intensity adjustments, with 5 sets of 10 repetitions twice a day during week days for five weeks both for CardioBreath and IMT. Patients will be evaluated immediately after hospital discharge and at the end of the Moment 1, they will carry out a washout period of one week between the moments 1 and 2 and new evaluations before and after moment 2. The data obtained will be analyzed by intention to treat (ITT) and presented as means (M) ± standard deviation (SD). Will be tested for normality through the test by Shapiro Wilk. Differences between interventions will be detected through Student's t-test for paired samples. Correlations between variables will be obtained by Pearson's correlations for parametric and Spearman for non-parametric data, with significance level p< 0.05. Expected Results: Although there is no data comparing IMT and slow breathing in CHF patients, significant results are expected in the two intervention groups, and differences between both protocols will point to their specific applicability.
- Conditions
- Congestive Heart Failure
- Being tested
- Moment 1: IMT. Moment 2 CardioBreath., Moment 1: CardioBreath and moment 2: IMT.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moment 1: IMT. Moment 2 CardioBreath.Device
Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks.
CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act.
Moment 1: CardioBreath and moment 2: IMT.Device
CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act.
Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - IMT CB | Active comparator | Moment 1: IMT and moment 2: CardioBreath. Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks.
CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act. Receives: Device: Moment 1: IMT. Moment 2 CardioBreath. |
| Group 2 - CB IMT | Active comparator | Moment 1: CardioBreath and moment 2: IMT. Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks.
CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act. Receives: Device: Moment 1: CardioBreath and moment 2: IMT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular autonomic control by heart rate variability(HRV)
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation acquired by Finometer and analyzed by Cardioseries Software.
Measured: Time Frame: 30 minutes
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation.
Heart rate variability collected by Polar V800 device and analyzed by Kubios Software. The 10 minutes assessment (concomitant with the Finometer acquisition) either for 5 weeks interventions and also in acute mode of 5 minutes of slow breathing of 10 cycles per minute (baseline 10 minutes/ 5 minutes slow breathing/ 10 minutes post intervention).
Measured: 30 minutes
Secondary outcomes (1)
Respiratory rate by Pneumotrace respiratory belt
Respiratory rate in cycles per minute (CPM)
Measured: 30 minutes along with Finometer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion20 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Crossover
- Model description
- Sequential Assignment The participants will be randomized into 2 intervention groups as follows: Group 1: Moment 1: IMT Moment 2: CardioBreath®App. Group 2: Moment 1: CardioBreath®App Moment 2: IMT. The intervention will long five weeks. The exercises will be performed at home for five days/week
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139653
- Sponsor's protocol ID
- UP6065/23
- Acronym
- CardioBreath
- Status last verified
- Dec 2024
- First submitted
- 31 Aug 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of CardioBreath Aplication Versus Inspiratory Muscle Training (IMT) on Vagal Cardiac Modulation, Pulse Wave Velocity Maximal Respiratory Pressures in Heart Failure Patients: Cross-over Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06139653
- Acronym / sponsor ID
- CardioBreath / UP6065/23
- Conditions
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Nov 2023 (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.
Heart failure (HF) is a systemic clinical syndrome defined as cardiac dysfunction, which causes inadequate blood supply to meet metabolic needs. One of the most expressive markers of HF is neurologic exacerbation, with expected sympathetic hyperactivation, increased activity of the renin-angiotensin-aldosterone system and elevation of vasopressin levels. These changes compensate the low cardiac output in the onset of ventricular dysfunction ensure a long term high blood perfusion pressure,though aggravate this dysfunction and contributes to the HF progression. There are evidences ofthe therapeutic effects of respiratory exercise techniques for HF patients. However, it demands new data for larger prescription and employment of these kind of exercises. Advanced technologies allowed the elaboration of the application for slow breathing CardioBreath. So far, it requires the possibility of comparison of their effects versus widely validated Inspiratory Muscle Trainig (IMT) on respiratory and cardiovascular outcomes in order to elucidate their specific benefits. In this way compare CardioBreath ® App versus IMT through a crossover randomized clinical trial design may elucidate the response effects of these interventions in these patients.
Detailed description
The impact of pulmonary, ventilatory and cardiovascular impairment in patients with congestive heart failure (CHF) highlights the therapeutic relevance of breathing exercises for these functions. In addition, other benefits such as lowering blood pressure,increased cardiac vagal modulation, improved vascular function and psychosocial handling (anxiety, depression and stress) may be expected. Inspiratory Muscle Training (IMT) and slow yoga breathing are widely endorsed as beneficial by a large amount of evidence. The newly developed app CardioBreath ® is based on a breathing technique of yoga (ujjayi pranayama) through respiratory rates (RR) slower than the user's spontaneous RR, in a set of strategies with pedagogical prescription, guidance and monitoring of this type of exercises. This study aims to compare IMT exercises with those of the CardioBreath ® application on , strength respiratory muscle (manuvacuometry), cardiac vagal modulation (heart rate variability), arterial stiffness (heart rate wave velocity) and diaphragm thickness in CHF patients after their hospital discharge in Institute of Cardiology of Rio Grande do Sul. Methods: Crossover randomized control trial will recruit post-discharge CHF patients who will be evaluated through, Finometer system (HR and BP variability/cardiac vagal modulation), Arterial Stiffness (oscillometric method), for indexes of central arterial pressure, velocity pulse waveform (large artery stiffness) and Aix 75 (small artery stiffness), Respiratory Muscle Strength by Manovacuometry and Diaphragm Thickness by ultrasound. Patients will be randomized to two orders of intervention Group 1- Moment 1 TMI and Moment 2 CardioBreath App Group 2- Moment 1 CardioBreath App and Moment 2 TMI. The interventions will face-to-face assistance once a week for intensity adjustments, with 5 sets of 10 repetitions twice a day during week days for five weeks both for CardioBreath and IMT. Patients will be evaluated immediately after hospital discharge and at the end of the Moment 1, they will carry out a washout period of one week between the moments 1 and 2 and new evaluations before and after moment 2. The data obtained will be analyzed by intention to treat (ITT) and presented as means (M) ± standard deviation (SD). Will be tested for normality through the test by Shapiro Wilk. Differences between interventions will be detected through Student's t-test for paired samples. Correlations between variables will be obtained by Pearson's correlations for parametric and Spearman for non-parametric data, with significance level p< 0.05. Expected Results: Although there is no data comparing IMT and slow breathing in CHF patients, significant results are expected in the two intervention groups, and differences between both protocols will point to their specific applicability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential Assignment The participants will be randomized into 2 intervention groups as follows: Group 1: Moment 1: IMT Moment 2: CardioBreath®App. Group 2: Moment 1: CardioBreath®App Moment 2: IMT. The intervention will long five weeks. The exercises will be performed at home for five days/week
| Arm | Type | Receives |
|---|---|---|
| Group 1 - IMT CB | Active comparator | Device: Moment 1: IMT. Moment 2 CardioBreath.Moment 1: IMT and moment 2: CardioBreath. Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks. CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act. |
| Group 2 - CB IMT | Active comparator | Device: Moment 1: CardioBreath and moment 2: IMT.Moment 1: CardioBreath and moment 2: IMT. Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks. CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consecutive CHF patients in treatment at the outpatient clinic (Institute of Cardiology)
- Of both sexes
- Aged between 40 and 70 years
- And ejection fraction (EF) reduced (<40%)
- Who have access to a mobile device with access to Internet.
Key exclusion criteria (5 listed)
- active smoking
- BMI <30
- Diagnosis of sleep apnea
- Heart failure of congenital origin
- Valve disease.
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 |
|---|---|---|
| Moment 1: IMT. Moment 2 CardioBreath.Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks. CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act. | Device | Group 1 - IMT CB |
| Moment 1: CardioBreath and moment 2: IMT.CardioBreathApp group will have the app settings of profile and spontaneous respiratory rate to determine the exercise rate of exercises, which will be performed at home for five days/week during 5 sets of one minute with 30' of rest between the sets twice a day. respiratory rate of exercise will be determined by 80% of spontaneous respiratory rate twice a day for five weeks. An once a week meeting will provide readjustment of respiratory rate to perform exercises. One week washout will be taken between the two interventions in order to cleanse motor memory of respiratory act. Participants will have PowerBreath device for IMT adjusted for 30% with weekly adjustment of maximal inspiratory pressure and will perform the exercise at home for five days/week. They will perform 5 sets of 10 repetitions twice a day for five weeks. | Device | Group 2 - CB IMT |
Primary outcome
Cardiovascular autonomic control by heart rate variability(HRV)
Time frame: Time Frame: 30 minutes
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation acquired by Finometer and analyzed by Cardioseries Software.
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation.
Time frame: 30 minutes
Heart rate variability collected by Polar V800 device and analyzed by Kubios Software. The 10 minutes assessment (concomitant with the Finometer acquisition) either for 5 weeks interventions and also in acute mode of 5 minutes of slow breathing of 10 cycles per minute (baseline 10 minutes/ 5 minutes slow breathing/ 10 minutes post intervention).
1 secondary outcome
Respiratory rate by Pneumotrace respiratory belt
Time frame: 30 minutes along with Finometer
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 15 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Congestive Heart Failure
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moment 1: IMT. Moment 2 CardioBreath. and Moment 1: CardioBreath and moment 2: IMT. in people with Congestive Heart Failure, run by Instituto de Cardiologia do Rio Grande do Sul 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 5 inclusion and 5 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 15 Aug 2025. 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?
Cardiovascular autonomic control by heart rate variability(HRV) (time frame: Time Frame: 30 minutes). 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?
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 15 Aug 2025.