Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension. (TREMVEN)

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

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

Study Overview

• Status: Unknown
• Conditions: Improvement of Functional Capacity.; Improvement of Quality of Life.; Improvement of Cardiovascular Autonomic Control.; Reduction of Blood Pressure in Hypertensive Patients.
• Intervention / Treatment: Other: Inspiratory Muscle Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90050-170
      • Pedro Dal Lago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory Muscle Training; It will me performed a loaded training of ventilatory muscles in patients with Hypertension. Its is done with the practice of breathing exercises associated to an training device, specific for this kind of 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences on blood pressure levels	Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.	eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of Heart rate variability		eight weeks
improvement of quality of life	To measure the quality of life, it is used the SF36 short form questionary.	eigth weeks
Improvement of Functional Capacity	It is measure by the oxytgen consumption accessed by ergospirometry.	eight weeks

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Instituto de Cardiologia do Rio Grande do Sul; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 29, 2010
• First Posted (Estimate): November 30, 2010

Study Record Updates

• Last Update Posted (Estimate): November 30, 2010
• Last Update Submitted That Met QC Criteria: November 29, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Hypertension; Cardiac Rehabilitation; Inspiratory Muscle Training; Breathing Exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: TREMVEN