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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250444
Recruitment Status : Unknown
Verified October 2010 by Federal University of Health Science of Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2010
Last Update Posted : November 30, 2010
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Instituto de Cardiologia do Rio Grande do Sul
Information provided by:
Federal University of Health Science of Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Reduction of Blood Pressure in Hypertensive Patients. Improvement of Cardiovascular Autonomic Control. Improvement of Functional Capacity. Improvement of Quality of Life. Other: Inspiratory Muscle Training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.
Study Start Date : March 2009
Actual Primary Completion Date : July 2010

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.

Primary Outcome Measures :
  1. Differences on blood pressure levels [ Time Frame: eight weeks ]
    Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.

Secondary Outcome Measures :
  1. improvement of Heart rate variability [ Time Frame: eight weeks ]
  2. improvement of quality of life [ Time Frame: eigth weeks ]
    To measure the quality of life, it is used the SF36 short form questionary.

  3. Improvement of Functional Capacity [ Time Frame: eight weeks ]
    It is measure by the oxytgen consumption accessed by ergospirometry.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01250444

Pedro Dal Lago
Porto Alegre, RS, Brazil, 90050-170
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Instituto de Cardiologia do Rio Grande do Sul

Responsible Party: Pedro Dal Lago, Federal University of Health Science of Porto Alegre Identifier: NCT01250444     History of Changes
Other Study ID Numbers: TREMVEN
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: October 2010

Keywords provided by Federal University of Health Science of Porto Alegre:
Inspiratory Muscle Training
Breathing Exercises
Cardiac Rehabilitation

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes