Actively Recruiting

Phase Not Applicable
Age: 45Years - 65Years
FEMALE
Healthy Volunteers
ID03672760

Inspiratory Muscle Training Versus CardioBreath App Effects on Vagal Modulation and Pulse Wave Velocity in Normotensive Postmenopausal Women

Led by Instituto de Cardiologia do Rio Grande do Sul · Updated on 2024-06-21

24

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of respiratory exercises on cardiovascular health, particularly focusing on cardiac vagal modulation and pulse wave velocity in normotensive postmenopausal women. This study compares two popular respiratory exercise methods: Inspiratory Muscle Training (IMT) and the newly developed CardioBreath® App. The goal is to validate the app as a tool for respiratory exercise and understand its impact on autonomic nervous system balance and vascular function. Participants will be randomly assigned to one of three groups: an active IMT group using a PowerBreath device with a 30% inspiratory load, a placebo IMT group using the same device without load, or a CardioBreath® App group using a guided app for breathing exercises. Each group will perform exercises at home for 10 minutes, five days a week, over five weeks. Weekly laboratory visits will allow for adjustments of the inspiratory load or respiratory rate based on individual performance. During the study, participants will undergo assessments including blood pressure, heart rate variability, pulse wave velocity, and central arterial pressure using specialized devices. These measures will evaluate autonomic and vascular responses before and after the intervention. Exercise adherence will be tracked through audio recordings for IMT groups and progress graphics for the app group. The study aims to provide a detailed analysis of cardiovascular autonomic control and vascular stiffness changes over the five-week period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Follicle Stimulating Hormone (FSH) >35 mui/ml
  • At least 12 months without menstruation
  • Sedentary lifestyle with less than 150 minutes of exercise per week
  • Female participants aged between 45 and 65 years
Not Eligible

You will not qualify if you...

  • Hypertension
  • Diabetes
  • Obesity
  • Use of beta blockers
  • Recent cardiovascular events or surgery
  • Kidney problems
  • Respiratory or motor disorders
  • Smoking
  • Body Mass Index (BMI) greater than 29.9

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 weeks

Participants perform respiratory exercises at home using either the PowerBreath device or the CardioBreath App for five days per week, 10 minutes each day. Weekly visits are held to adjust device load or respiratory rates as needed.

Weekly visits for load or rate adjustment

Follow-up

Duration - 1 day

Participants are re-evaluated for cardiovascular autonomic control and pulse wave velocity to assess the effects of the respiratory exercises.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Instituto de Cardiologia do Rio Grande do Sul

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

Actively Recruiting

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Research Team

C

Cláudia Fetter, MSc

L

Liliana Boll, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

3

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