- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01292902
Regional Distribution of Ventilation in Patients With Chronic Heart Failure
February 9, 2011 updated by: Universidade Federal de Pernambuco
Inspiratory muscle dysfunction is a reduction in the ability to generate pressure and force by the inspiratory muscles.
This decrease in the strength of these muscles can be attributed to biochemical and histological changes.
Some patients with CHF showed a reduction of maximal inspiratory pressure (MIP) and inspiratory muscle endurance, and such factors known to exercise limitation and deterioration in quality of life and worsens the prognosis of these patients.
This study aims to evaluate the Regional pulmonary distribution volume and the influence of enclosures system thoracoabdominal in CHF patients with cardiomegaly associated with diaphragmatic weakness during quiet breathing and during exercise for inspiratory muscle and its correlation with functional data.
The investigators evaluated a total of 31 individuals divided into two groups: CHF and control.
In the control group, twelve volunteers participated with similar age, gender and body mass index in relation to the group of patients with CHF.
The control group participants had an ejection fraction of left ventricle (EF)> 50% without cardiac abnormalities of the cameras and MIP over 80% of predicted.
To conduct the exercise to the inspiratory muscles (EMI) was used for IMT Threshold ® device (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar Grove, New Jersey) is one of the most used for training of inspiratory muscles in patients with several pathologies such as CHF.
The exercise time was 3 minutes.
During this period, participants were encouraged to only breathe through the mouth and maintain a respiratory rate between 12 and 16ipm.
Opto-electronic plethysmography measures the volume changes of thoracoabdominal system by placing 89 markers formed by hemiesferas covered with retro-reflective paper, taking the place of each of these hemiesferas determined by anatomical landmarks on the anterior and posterior regions of the chest and abdomen.
According to our study, a lower ventilation on diaphragmatic region would lead to an increased perception of dyspnea during submaximal exercise in this population.
Moreover, the observed changes in the pattern of regional distribution of ventilation in CHF patients compared to healthy individuals can serve as a basis for prospective cohort studies using IMT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil
- Universidade Federal de Pernamabuco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed as CHF associated with cardiomegaly
- Class II and III (NYHA)
- Left ventricular minor 45% (method Teicholtz)
- Inspiratory muscle weakness (PiMáxima <70% predicted)
- Duration of symptoms > 1 year
- Body mass index (BMI) < 35kg/m2
- Non-smokers or former smokers with a smoking history < 10 pack-years
Exclusion Criteria:
- Patients with chronic heart failure who had unstable angina, myocardial infarction or heart surgery until three months before the survey
- Orthopedic diseases or respiratory comorbidities such as asthma and COPD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: healthy volunteers
|
To conduct the exercise to the inspiratory muscles was used for IMT Threshold ® device (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar Grove, New Jersey) is one of the most used for training of inspiratory muscles in patients with several pathologies such as ICC.Threshold ® has been engaged in the patient's mouth by a mouthpiece, with the nose occluded by a nose clip.
The exercise time was 3 minutes.
During this period, participants were encouraged to only breathe through the mouth and maintain a respiratory rate between 12 and 16ipm.
The exercise would be stopped if HR increased more than 20% and / or SpO2 < 88%.
Equal to the group with chronic heart failure.
|
Other: chronic heart failure
|
To conduct the exercise to the inspiratory muscles was used for IMT Threshold ® device (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar Grove, New Jersey) is one of the most used for training of inspiratory muscles in patients with several pathologies such as ICC.Threshold ® has been engaged in the patient's mouth by a mouthpiece, with the nose occluded by a nose clip.
The exercise time was 3 minutes.
During this period, participants were encouraged to only breathe through the mouth and maintain a respiratory rate between 12 and 16ipm.
The exercise would be stopped if HR increased more than 20% and / or SpO2 < 88%.
Equal to the group with chronic heart failure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opto-electronic plethysmography
Time Frame: 1 year
|
The POE (BTS Bioengineering, Italy) measures the volume changes of thoracoabdominal system through placement of 89 markers formed by hemiesferas covered with retro-reflective paper, taking the place of each of these hemiesferas determined by anatomical landmarks in anterior and posterior thorax and abdomen.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Functional Capacity
Time Frame: 1 year
|
To assess the functional capacity test was used for 6-minute walk (6MWT) according to the protocol established by the American Thoracic Society (ATS).
Before the test parameters were assessed resting blood pressure (BP), Heart Rate (HR), Oxygen Saturation (SpO2 - pulse oximetry portable Onix 9500), Respiratory Frequency (RF) and dyspnea scale (scale Borg).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 9, 2011
First Submitted That Met QC Criteria
February 9, 2011
First Posted (Estimate)
February 10, 2011
Study Record Updates
Last Update Posted (Estimate)
February 10, 2011
Last Update Submitted That Met QC Criteria
February 9, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27012011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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