Overview

This trial is active, not recruiting.

Conditions reduction of blood pressure in hypertensive patients., improvement of cardiovascular autonomic control., improvement of functional capacity., improvement of quality of life.
Treatment inspiratory muscle training
Sponsor Federal University of Health Science of Porto Alegre
Collaborator Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Start date March 2009
End date July 2010
Trial size 14 participants
Trial identifier NCT01250444, TREMVEN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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 Outcomes

Measure
Differences on blood pressure levels
time frame: eight weeks

Secondary Outcomes

Measure
improvement of Heart rate variability
time frame: eight weeks
improvement of quality of life
time frame: eigth weeks
Improvement of Functional Capacity
time frame: eight weeks

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Federal University of Health Science of Porto Alegre.