CardioBreathApp vs IMT in Heart Failure

Congestive Heart Failure Clinical Trial

— CardioBreath  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139653
• Other study ID #: UP6065/23
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Jéssica Fagundes Niec, graduation
• Phone: +5551997277544
• Email: jessfniec[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• active smoking

• BMI <30

• Diagnosis of sleep apnea

• Heart failure of congenital origin

• Valve disease.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Cardiology Institute of Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Carotid -femoral pulse wave velocity (VOP)	Arterial Stiffness (oscillometric method - Arteris)	15 minutes
Other	Diaphragm Thickness by ultrasound	Increase diaphragm thickness (mm)	5 minutes
Other	Strength Respiratory Muscle	Manuvacuometry	10 minutes
Primary	Cardiovascular autonomic control by heart rate variability(HRV)	High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation.	Time Frame: 30 minutes
Secondary	Respiratory rate by Pneumotrace respiratory belt	Respiratory rate in cycles per minute (CPM)	30 minutes along with Finometer