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

NCT03672760 | Recruiting

• 1 other identifier: Cardiology
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Disorder; Autonomic Imbalance; Vascular Stiffness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Carotid -femoral pulse wave velocity (Complior)

  10 minutes

Other Outcomes (2)

• Respiratory rate by Pneumotrace respiratory belt

  30 minutes along with Finometer

• Diaphragm Thickness by ultrasound

  5 minutes

Study Arms (3)

IMT PowerBreath

ACTIVE COMPARATOR

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

IMT PowerBreath Placebo

PLACEBO COMPARATOR

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

CardioBreathApp

ACTIVE COMPARATOR

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

Interventions

CardioBreathApp DEVICE

Respiratory exercises performed with CardioBreathApp prescription and voice and visual guidance

CardioBreathApp

IMT PowerBreath DEVICE

Inspiratory Muscle Training (IMT) performed with 30% load based on Maximal Inspiratory Pressure

IMT PowerBreath

IMT PowerBreath Placebo DEVICE

Inspiratory Muscle Training (IMT) without load

IMT PowerBreath Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hypertension
• Diabetes
• Obesity
• Use of Betablockers
• recent cardiovascular events or surgery
• renal alterations
• respiratory and/or motor pathologies
• smoking
• BMI\>29,9

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

RECRUITING

Central Study Contacts

Cláudia Fetter, MSc

CONTACT

+5551984516888; profclaudiafetter@gmail.com

Liliana Boll, MSc

CONTACT

+55 51 32303600; liliana.lic@cardiologia.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know about other arms. Outcome assessors will not know the arms participant belong.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 14, 2018
• Study Start: September 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: July 30, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)