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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03672760
Other study ID # Cardiology
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date July 30, 2025

Study information

Verified date June 2024
Source Instituto de Cardiologia do Rio Grande do Sul
Contact Cláudia Fetter, MSc
Phone +5551984516888
Email profclaudiafetter@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 30, 2025
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility 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

Study Design


Intervention

Device:
CardioBreathApp
Respiratory exercises performed with CardioBreathApp prescription and voice and visual guidance
IMT PowerBreath
Inspiratory Muscle Training (IMT) performed with 30% load based on Maximal Inspiratory Pressure
IMT PowerBreath Placebo
Inspiratory Muscle Training (IMT) without load

Locations

Country Name City State
Brazil Instituto de Cardiologia do 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 Respiratory rate by Pneumotrace respiratory belt Respiratory rate in cycles per minute (CPM) 30 minutes along with Finometer
Other Diaphragm Thickness by ultrasound Increase diaphragm thickness (mm) 5 minutes
Primary Cardiovascular autonomic control by heart rate variability(HRV) High Frequency (HF) component of HRV (ms2 = squared milliseconds) as measure of vagal modulation 30 minutes
Secondary Carotid -femoral pulse wave velocity (Complior) Reduction of carotid -femoral pulse wave velocity (m/s) 10 minutes
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