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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Federal University of Health Science of Porto Alegre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01250444
First received: November 29, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

November 29, 2010
November 29, 2010
March 2009
July 2010   (final data collection date for primary outcome measure)
Differences on blood pressure levels [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.
Same as current
No Changes Posted
  • improvement of Heart rate variability [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  • improvement of quality of life [ Time Frame: eigth weeks ] [ Designated as safety issue: No ]
    To measure the quality of life, it is used the SF36 short form questionary.
  • Improvement of Functional Capacity [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
    It is measure by the oxytgen consumption accessed by ergospirometry.
Same as current
Not Provided
Not Provided
 
Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.
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.
Intervention: Other: Inspiratory Muscle Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01250444
TREMVEN
Yes
Pedro Dal Lago, Federal University of Health Science of Porto Alegre
Federal University of Health Science of Porto Alegre
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Instituto de Cardiologia do Rio Grande do Sul
Not Provided
Federal University of Health Science of Porto Alegre
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP