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Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity (CardioBreath)

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ClinicalTrials.gov Identifier: NCT03672760
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul

Study Description
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Brief Summary:
Existing data points to relevant beneficial effects of respiratory exercises on cardiovascular health, with special regards to decreases on arterial pressure and improves on autonomic and vascular profiles, though mechanistics of such results have not yet been cleared. Among the available ways to perform respiratory exercises, there is the highly recommended Inspiratory Muscle Training (IMT) and slow breathing exercises like Yoga pranayamas. Lately, the development of new technologies has allowed the use of Apps to perform respiratory exercises. This study will be take the just developed CardioBreath®App to validate it as a tool to perform respiratory exercises. Therefore, it will be compared to IMT on cardiac vagal modulation and pulse wave velocity on normotensive post menopause women.

Condition or disease Intervention/treatment Phase
Postmenopausal Disorder Autonomic Imbalance Vascular Stiffness Device: CardioBreathApp Device: IMT PowerBreath Device: IMT PowerBreath Placebo Not Applicable

Detailed Description:

Menopause years represent an increasing risk for hypertension and autonomic nervous system (ANS), endothelial and vascular imbalance. Existing data point to beneficial effects of respiratory exercises either on ANS and light on therapeutic relevance of these kind of exercises on prevention and treatment of cardiovascular and pulmonary diseases. However, few data is available about the effects of respiratory exercises on both vascular and endothelial function, and its possible interactions with ANS. Besides that, recommendations of slower respiratory rates are associated to healthier physical and psychological states. Among available techniques to perform breathing exercises, most referenced are Inspiratory Muscle Training (IMT) and Yoga based slow breathing (pranayamas). New technologies have allowed the development of Apps which aim to ease the possibilities of exercising breathing.

IMT uses a mouth device for pressure adjustment and presents a variety e training forms including combinations of intensity and volume through loads adjustment. It aims the enhancement of respiratory muscles strength and endurance.

CardioBreath®App has been developed by experienced physical education and yoga professional based on individual prescription of respiratory rates to workout through voice and image guidance of both posture and breathing technique. The performance might be followed through a progression map. It´s available in portuguese language for Android and Ios, has been submitted to Brazilian Trend Marks Institute (INPI) which has not shown opposition to the registration.

It´s a randomized clinical trial recruiting normotensive post menopause women. Eligible participants will be assessed by Finometer for blood pressure and heart rate variability as measures for autonomic outcomes. Data analysis of these data will be processed by CardioSeries software through Fourier fast transform (FFT) in order to generate vagal and sympathetic values. For pulse wave velocity and central arterial pressure the participants will be assessed by Complior Analyser. Endothelial function will be evaluated through ultrasonography of brachial artery (Flow Mediated Dilation - FMD-) at baseline and after 5 minutes reactive hyperemia with a cuffing installed in forearm at 200 mm Hg for 5 minutes. Images will be recorded and Cardiovascular Suite software will be used for analysis of flow and dilation.

The participants will be randomized into 3 intervention groups as follows: IMT, IMT placebo and CardioBreath®App. The intervention will long five weeks. The exercises will be performed at home for five days/ week during 10 minutes and will be registered by audio for whatsapp (IMT) and "Progress" graphics (CardioBreath®App) Once a week they will visit the laboratory set to adjust loads (IMT) and respiratory rates in CardioBreath®App groups, respectively.

After five weeks the participants will be re-evaluated for all outcomes described above.

Data analysis will be provided by ANOVA of two repeated measures and Bonferroni post hoc. All data will be presented in mean +- standard deviation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The participants will be randomized into 3 intervention groups as follows: IMT, IMT placebo and CardioBreath®App. The intervention will long five weeks. The exercises will be performed at home for five days/ week during 10 minute
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not know about other arms. Outcome assessors will not know the arms participant belong.
Primary Purpose: Prevention
Official Title: Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity On Normotensive Postmenopause Women : Randomized Clinical Trial
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: IMT PowerBreath

Participants will have PowerBreath device for IMT adjusted for 30% of maximal inspiratory pressure and will perform the exercise at home for five days/week during 10 minutes for five weeks.

An once a week meeting will provide re-adjustment of load through maximal inspiratory pressure performance

 Device: IMT PowerBreath
Inspiratory Muscle Training (IMT) performed with 30% load based on Maximal Inspiratory Pressure
Placebo Comparator: IMT PowerBreath Placebo

Participants will have PowerBreath device for IMT with no load and will perform the exercise at home for five days/week during 10 minutes for five weeks.

An once a week meeting will not re-adjustment the load though maximal inspiratory pressure performance will be performed

 Device: IMT PowerBreath Placebo
Inspiratory Muscle Training (IMT) without load
Active Comparator: CardioBreathApp
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 10 minutes for five weeks An once a week meeting will provide re-adjustment of respiratory rate to perform exercises
 Device: CardioBreathApp
Respiratory exercises performed with CardioBreathApp prescription and voice and visual guidance


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular autonomic control by heart rate variability(HRV) [ Time Frame: 30 minutes ]
    High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation


Secondary Outcome Measures :
  1. Carotid -femoral pulse wave velocity (Complior) [ Time Frame: 10 minutes ]
    Reduction of carotid -femoral pulse wave velocity (m/s)


Other Outcome Measures:
  1. Respiratory rate by Pneumotrace respiratory belt [ Time Frame: 30 minutes along with Finometer ]
    Respiratory rate in cycles per minute (CPM)

  2. Flow mediated dilation (FMD) of brachial artery by ultrasound [ Time Frame: 30 minutes ]
    Increase Flow Mediated Dilation (FMD) (%)

  3. Diaphragm Thickness by ultrasound [ Time Frame: 5 minutes ]
    Increase diaphragm thickness (mm)

  4. Intima Media Thickness of carotid artery by ultrasound [ Time Frame: 5 minutes ]
    Decrease of intima media thickness (IMT) (mm)


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Follicle Stimulating Hormone (FSH)>35mui/ml
  • minimum 12 months amenorrhea
  • sedentary life style (less than 150 minutes per week of exercise)

Exclusion Criteria:

  • Hypertension
  • Diabetes
  • Obesity
  • Use of Betablockers
  • recent cardiovascular events or surgery
  • renal alterations
  • respiratory and/or motor pathologies
  • smoking
  • BMI>29,9
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672760


Contacts
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Contact: Cláudia Fetter, MSc +5551984516888 profclaudiafetter@gmail.com
Contact: Liliana Boll, MSc +55 51 32303600 ext 4070 liliana.lic@cardiologia.org.br

Locations
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Brazil
Cardiology Institute of Rio Grande do Sul
Pôrto Alegre, Rio Grande Do Sul, Brazil
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
More Information
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Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03672760    
Other Study ID Numbers: Cardiology
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes