CClinicalTrials.gg
Status unknownNCT01250444TREMVENUpdated Nov 30, 2010

Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.

An interventional study of Inspiratory Muscle Training in Reduction of Blood Pressure in Hypertensive Patients., Improvement of Cardiovascular Autonomic Control. and Improvement of Functional Capacity., sponsored by Federal University of Health Science of Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-11-30.

Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 14 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Federal University of Health Science of Porto Alegre is the lead sponsor of 118 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
14 participants (estimated)

Study arms

  • 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

Interventions

  • OtherInspiratory Muscle Training

    Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.

06

What researchers measure

Primary outcomes

  1. Differences on blood pressure levels

    Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.

    Time frame: eight weeks

Secondary outcomes

  1. improvement of Heart rate variability

    Time frame: eight weeks

  2. improvement of quality of life

    To measure the quality of life, it is used the SF36 short form questionary.

    Time frame: eigth weeks

  3. Improvement of Functional Capacity

    It is measure by the oxytgen consumption accessed by ergospirometry.

    Time frame: eight weeks

07

Study locations

1 site
  • Pedro Dal Lago
    Porto Alegre, RS 90050-170, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01250444
Lead sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
First posted
Nov 30, 2010
Start date
Mar 2009
Primary completion
Jul 2010
Last update
Nov 30, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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