- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03672760
Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity (CardioBreath)
Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity On Normotensive Postmenopause Women : Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cláudia Fetter, MSc
- Phone Number: +5551984516888
- Email: profclaudiafetter@gmail.com
Study Contact Backup
- Name: Liliana Boll, MSc
- Phone Number: 4070 +55 51 32303600
- Email: liliana.lic@cardiologia.org.br
Study Locations
-
-
Rio Grande Do Sul
-
Pôrto Alegre, Rio Grande Do Sul, Brazil
- Cardiology Institute of Rio Grande do Sul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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 |
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 |
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
|
Respiratory exercises performed with CardioBreathApp prescription and voice and visual guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carotid -femoral pulse wave velocity (Complior)
Time Frame: 10 minutes
|
Reduction of carotid -femoral pulse wave velocity (m/s)
|
10 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragm Thickness by ultrasound
Time Frame: 5 minutes
|
Increase diaphragm thickness (mm)
|
5 minutes
|
Respiratory rate by Pneumotrace respiratory belt
Time Frame: 30 minutes along with Finometer
|
Respiratory rate in cycles per minute (CPM)
|
30 minutes along with Finometer
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cardiology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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