Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.

Improvement of Cardiovascular Autonomic Control. Clinical Trial

— TREMVEN  

Official title:

Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01250444
• Other study ID #: TREMVEN
• Status: Unknown status
• Phase: N/A
• First received: November 29, 2010
• Last updated: November 29, 2010
• Start date: March 2009

Study information

• Verified date: October 2010
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine inspiratory muscle training effects on blood pressure, functional capacity and quality of life in hypertensive patients.

Description:

The interaction between respiratory function and cardiovascular system, as well as the present alterations in these systems, due to diseases such as Hypertension, diabetes and chronic heart failure, are the factors that potentially participate of the pathogenic frame in these situations. Consequently, it is so related to reduction of functional capacity, endothelial dysfunction of the sympathetic and parasympathetic cardiovascular control and morphologic alterations on the skeletal muscles, including ventilatory muscles.

On the other hand, a proinflammatory state also participates of this dysfunction and reduced function capacity situation. Cardiovascular risk factors, such as hypertension, increased heart rate variability, diabetes and heart failure explain the occurrence of the majority of cardiovascular events in the entire world and so in Brazil. Studies with experimental models and in patients with cardiovascular diseases identified important inflammatory activity associated to risk factors and preceding clinical events.

Inspiratory muscle training (IMT) shows consistent results in the improvement of functional capacity in athletes, sedentary subjects, heart failure patients and in animals submitted to an IMT model.

The study of alterations in cardiorespiratory interaction, functional capacity and cardiovascular control mechanisms (sympathetic, parasympathetic by heart rate variability), altogether, in hypertension, is a single opportunity to identify new pathogenic mechanisms involved in the reduction of functional capacity as well as promote its quantification. Therefore, the effects of IMT on these alterations are still not well understood. In this way, the response to IMT is a complement to epidemiologic and clinical models, as potential source of new possibilities in the research field.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 14
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 25 and 70

2. Hypertension in all stages:

2.1. Prehypertension - Systolic blood pressure (SBP) of 120 to 139 and/or diastolic blood pressure (DBP) of 80 to 89 mmHg 2.2.Stage 1 Hypertension - SBP of 140 to 159 mmHg and/or DBP of 90 to 99 mmHg 2.3.Stage 2 Hypertension - SBP = 160 mmHg and/or DBP = 100 mmHg

Exclusion Criteria:

1. Disagreement with consent form

2. Thoracic pain (angina)

3. Hypertension instability

4. Antihypertensive drugs alterations within 30 days before or during the study

5. Diabetes

6. Chronic pulmonary obstructive disease

7. Incapability of executing the functional tests

8. Asthma

9. Chronic Heart Failure

10. Obesity

11. Cardiovascular diseases complications

Related Conditions & MeSH terms

• Improvement of Cardiovascular Autonomic Control.
• Improvement of Functional Capacity.
• Improvement of Quality of Life.
• Reduction of Blood Pressure in Hypertensive Patients.
• Respiratory Aspiration

Intervention

Other:
• Inspiratory Muscle Training
Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.

Locations

Country	Name	City	State
Brazil	Pedro Dal Lago	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences on blood pressure levels	Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.	eight weeks
Secondary	improvement of Heart rate variability		eight weeks
Secondary	improvement of quality of life	To measure the quality of life, it is used the SF36 short form questionary.	eigth weeks
Secondary	Improvement of Functional Capacity	It is measure by the oxytgen consumption accessed by ergospirometry.	eight weeks