Clinical trial NCT01250444: Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.
Official title: Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Instituto de Cardiologia do Rio Grande do Sul
First posted: 2010-11-30
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences on blood pressure levels
timeFrame: eight weeks
Secondary outcomes:
measure: improvement of Heart rate variability
timeFrame: eight weeks
measure: improvement of quality of life
timeFrame: eigth weeks
measure: Improvement of Functional Capacity
timeFrame: eight weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pedro Dal Lago
state: RS
Study officials:
References: