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

Primary Purpose

Reduction of Blood Pressure in Hypertensive Patients., Improvement of Cardiovascular Autonomic Control., Improvement of Functional Capacity.

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduction of Blood Pressure in Hypertensive Patients. focused on measuring Inspiratory Muscle Training, Hypertension, Breathing Exercises, Cardiac Rehabilitation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pedro Dal Lago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inspiratory Muscle Training

Arm Description

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.

Outcomes

Primary Outcome Measures

Differences on blood pressure levels
Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.

Secondary Outcome Measures

improvement of Heart rate variability
improvement of quality of life
To measure the quality of life, it is used the SF36 short form questionary.
Improvement of Functional Capacity
It is measure by the oxytgen consumption accessed by ergospirometry.

Full Information

First Posted
November 29, 2010
Last Updated
November 29, 2010
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT01250444
Brief Title
Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.
Acronym
TREMVEN
Official Title
Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction of Blood Pressure in Hypertensive Patients., Improvement of Cardiovascular Autonomic Control., Improvement of Functional Capacity., Improvement of Quality of Life.
Keywords
Inspiratory Muscle Training, Hypertension, Breathing Exercises, Cardiac Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.
Primary Outcome Measure Information:
Title
Differences on blood pressure levels
Description
Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
improvement of Heart rate variability
Time Frame
eight weeks
Title
improvement of quality of life
Description
To measure the quality of life, it is used the SF36 short form questionary.
Time Frame
eigth weeks
Title
Improvement of Functional Capacity
Description
It is measure by the oxytgen consumption accessed by ergospirometry.
Time Frame
eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 25 and 70 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: Disagreement with consent form Thoracic pain (angina) Hypertension instability Antihypertensive drugs alterations within 30 days before or during the study Diabetes Chronic pulmonary obstructive disease Incapability of executing the functional tests Asthma Chronic Heart Failure Obesity Cardiovascular diseases complications
Facility Information:
Facility Name
Pedro Dal Lago
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.

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