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

Primary Purpose

Postmenopausal Disorder, Autonomic Imbalance, Vascular Stiffness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CardioBreathApp
IMT PowerBreath
IMT PowerBreath Placebo
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postmenopausal Disorder

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cardiology Institute of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

IMT PowerBreath

IMT PowerBreath Placebo

CardioBreathApp

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Cardiovascular autonomic control by heart rate variability(HRV)
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation

Secondary Outcome Measures

Carotid -femoral pulse wave velocity (Complior)
Reduction of carotid -femoral pulse wave velocity (m/s)

Full Information

First Posted
September 6, 2018
Last Updated
June 29, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03672760
Brief Title
Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity
Acronym
CardioBreath
Official Title
Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity On Normotensive Postmenopause Women : Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Menopause years represent an increasing risk for hypertension and autonomic nervous system (ANS) 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 function and 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Disorder, Autonomic Imbalance, Vascular Stiffness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
ParticipantOutcomes Assessor
Masking Description
Participants will not know about other arms. Outcome assessors will not know the arms participant belong.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMT PowerBreath
Arm Type
Active Comparator
Arm Description
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
Arm Title
IMT PowerBreath Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
CardioBreathApp
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CardioBreathApp
Intervention Description
Respiratory exercises performed with CardioBreathApp prescription and voice and visual guidance
Intervention Type
Device
Intervention Name(s)
IMT PowerBreath
Intervention Description
Inspiratory Muscle Training (IMT) performed with 30% load based on Maximal Inspiratory Pressure
Intervention Type
Device
Intervention Name(s)
IMT PowerBreath Placebo
Intervention Description
Inspiratory Muscle Training (IMT) without load
Primary Outcome Measure Information:
Title
Cardiovascular autonomic control by heart rate variability(HRV)
Description
High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Carotid -femoral pulse wave velocity (Complior)
Description
Reduction of carotid -femoral pulse wave velocity (m/s)
Time Frame
10 minutes
Other Pre-specified Outcome Measures:
Title
Respiratory rate by Pneumotrace respiratory belt
Description
Respiratory rate in cycles per minute (CPM)
Time Frame
30 minutes along with Finometer
Title
Diaphragm Thickness by ultrasound
Description
Increase diaphragm thickness (mm)
Time Frame
5 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cláudia Fetter, MSc
Phone
+5551984516888
Email
profclaudiafetter@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liliana Boll, MSc
Phone
+55 51 32303600
Ext
4070
Email
liliana.lic@cardiologia.org.br
Facility Information:
Facility Name
Cardiology Institute of Rio Grande do Sul
City
Pôrto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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