Chronic Heart FailureNCT01292902
Regional Distribution of Ventilation in Patients With Chronic Heart Failure
A study testing inspiratory muscle exercise in people with Chronic Heart Failure, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- inspiratory muscle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Heart Failure
- Being tested
- inspiratory muscle exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle exerciseOther
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%.
inspiratory muscle exerciseOther
Equal to the group with chronic heart failure.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Active comparator | Not described Receives: Other: inspiratory muscle exercise |
| chronic heart failure | Other | Not described Receives: Other: inspiratory muscle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opto-electronic plethysmography
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.
Measured: 1 year
Secondary outcomes (1)
Assessment of Functional Capacity
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292902
- Sponsor's protocol ID
- 27012011
- Status last verified
- Jan 2011
- First submitted
- 9 Feb 2011
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ernst ER, Shub C, Bailey KR, Brown LR, Redfield MM. Radiographic measurements of cardiac size as predictors of outcome in patients with dilated cardiomyopathy. J Card Fail. 2001 Mar;7(1):13-20. doi: 10.1054/jcaf.2001.23244.
PubMed 11264545
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Distribution of Ventilation in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01292902
- Acronym / sponsor ID
- 27012011
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Active comparator | Other: inspiratory muscle exercise |
| chronic heart failure | Other | Other: inspiratory muscle exercise |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle exerciseTo 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%. | Other | chronic heart failure |
| inspiratory muscle exerciseEqual to the group with chronic heart failure. | Other | healthy volunteers |
Primary outcome
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 secondary outcome
Assessment of Functional Capacity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
- Results publication: PubMed 11264545Ernst ER, Shub C, Bailey KR, Brown LR, Redfield MM. Radiographic measurements of cardiac size as predictors of outcome in patients with dilated cardiomyopathy. J Card Fail. 2001 Mar;7(1):13-20. doi: 10.1054/jcaf.2001.23244.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle exercise in people with Chronic Heart Failure, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opto-electronic plethysmography (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2011.