CardioBreathApp vs IMT in Heart Failure

NCT06139653 | Completed

• 1 other identifier: UP6065/23
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  30 minutes

Secondary Outcomes (1)

• Respiratory rate by Pneumotrace respiratory belt

  30 minutes along with Finometer

Other Outcomes (3)

• Carotid -femoral pulse wave velocity (VOP)

  15 minutes

• Diaphragm Thickness by ultrasound

  5 minutes

• Strength Respiratory Muscle

  10 minutes

Study Arms (2)

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.

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.

Device: Moment 1: CardioBreath and moment 2: IMT.

Interventions

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.

Group 1 - IMT CB

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.

Group 2 - CB IMT

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• active smoking
• BMI \<30
• Diagnosis of sleep apnea
• Heart failure of congenital origin
• Valve disease.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Cardiology Institute of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) Participants will not know about other arms. Outcome assessors will not know the arms participant belong.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)