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
  Purpose

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 Intervention
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 Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • Differences on blood pressure levels [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
    Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 14
Study Start Date: March 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250444

Locations
Brazil
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
  More Information

No publications provided

Responsible Party: Pedro Dal Lago, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT01250444     History of Changes
Other Study ID Numbers: TREMVEN
Study First Received: November 29, 2010
Last Updated: November 29, 2010
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Respiratory Aspiration
Hypertension
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014