Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension. (TREMVEN)
Recruitment status was Active, not recruiting
The purpose of this study is to determine inspiratory muscle training effects on blood pressure, functional capacity and quality of life in hypertensive patients.
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.|
- Differences on blood pressure levels [ Time Frame: eight weeks ] [ Designated as safety issue: No ]Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.
- 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.
|Study Start Date:||March 2009|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250444
|Pedro Dal Lago|
|Porto Alegre, RS, Brazil, 90050-170|