Heart DiseasesNCT01952002
Clinical Safety for the Inspiratory Muscle Training
An observational study of Heart Diseases and Lung Disease, run by Clínica de Medicina do Exercício at 1 site in Brazil.
Trial summary
The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic responses during an inspiratory muscle training session during a single cardiopulmonary rehabilitation session program. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Lung Disease
- What is being tested?
- Inspiratory Muscle Training
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Jun 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients regularly attending a supervised exercise program
Who may be able to join
- Patients regularly attending a supervised exercise program
- Patients were already performing the IMT in their usual supervisioned exercise sessions
Who cannot join
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinimex - Clínica de Medicina do Exercício
Rio de Janeiro, Rio de Janeiro, 22031-070
About this study
Official title: CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM
The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic responses during an inspiratory muscle training session during a single cardiopulmonary rehabilitation session program. An electrocardiogram will be continuously recorded and the heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately after a single inspiratory muscle training (IMT) session, consisting of two series of 15 cycles, with one-minute intervals between sets and an initial load of at least 30% of the initial maximal inspiratory pressure (MIP).
- Conditions
- Heart Diseases, Lung Disease
- Being tested
- Inspiratory Muscle Training
- Keywords
- Blood Pressure, heart rate, electrocardiogram, Cardiac arrhythmias, respiratory exercise
- Medical subject headings
- Heart Diseases, Lung Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Each session The session itself consisted of the following: two sets of 15 breathe cycles without removing the breathing promoter from the mouth and with the aid of a nose clip and 1-minute interval between sets. For training, we used the breathing promoters Power Breathe® Plus Light and Medium Resistance, possessing 10 levels of load gradation ranging from 17 to 186 cm H2O, which were adjusted for each patient and allowed for the individualized prescription of IMT
| Study group | Role | What they receive |
|---|---|---|
| IMT - Inspiratory Muscle Training | 21 (16 males/5 femalesen) with a mean age of 73 ± 7.4 years were studied. Among the 21 study participants, the most prevalent clinical condition was coronary artery disease (11 cases); four individuals showing a diagnosis of chronic obstructive pulmonary disease and/or asthma, two presented congestive heart failure and the last four had other diseases Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
abnormal clinical responses
During an IMT session, with two sets of 15 cycles at 30% of the load observed in MIP, there were no significant clinical or hemodynamic changes in patients regularly attending a supervised exercise program. In contrast, there are relatively frequent inductions of cardiac arrhythmias, mostly of low complexity, and more rarely, fleeting changes in ventricular repolarization during an IMT session.
Measured: One day
Secondary outcomes (2)
hemodynamic (blood pressure and heart rate) responses
Measured: one day
electrocardiographic pattern changes
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Clínica de Medicina do Exercício
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952002
- Sponsor's protocol ID
- 0166.0.000.399-11
- Other IDs
- 304328/2011-1
- Status last verified
- Sep 2013
- First submitted
- 23 Sep 2013
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM
- ClinicalTrials.gov ID
- NCT01952002
- Acronym / sponsor ID
- 0166.0.000.399-11
- Conditions
- Heart Diseases, Lung Disease
- Keywords
- Blood Pressure, heart rate, electrocardiogram, Cardiac arrhythmias, respiratory exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Clínica de Medicina do ExercícioUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Sep 2013 (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.
The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic responses during an inspiratory muscle training session during a single cardiopulmonary rehabilitation session program. An electrocardiogram will be continuously recorded and the heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately after a single inspiratory muscle training (IMT) session, consisting of two series of 15 cycles, with one-minute intervals between sets and an initial load of at least 30% of the initial maximal inspiratory pressure (MIP).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMT - Inspiratory Muscle Training | – | Other: Inspiratory Muscle Training21 (16 males/5 femalesen) with a mean age of 73 ± 7.4 years were studied. Among the 21 study participants, the most prevalent clinical condition was coronary artery disease (11 cases); four individuals showing a diagnosis of chronic obstructive pulmonary disease and/or asthma, two presented congestive heart failure and the last four had other diseases |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients regularly attending a supervised exercise program
Key inclusion criteria (2 listed)
- Patients regularly attending a supervised exercise program
- Patients were already performing the IMT in their usual supervisioned exercise sessions
Key exclusion criteria (1 listed)
- cognitive impairment
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 TrainingEach session The session itself consisted of the following: two sets of 15 breathe cycles without removing the breathing promoter from the mouth and with the aid of a nose clip and 1-minute interval between sets. For training, we used the breathing promoters Power Breathe® Plus Light and Medium Resistance, possessing 10 levels of load gradation ranging from 17 to 186 cm H2O, which were adjusted for each patient and allowed for the individualized prescription of IMT | Other | IMT - Inspiratory Muscle Training |
Primary outcome
abnormal clinical responses
Time frame: One day
During an IMT session, with two sets of 15 cycles at 30% of the load observed in MIP, there were no significant clinical or hemodynamic changes in patients regularly attending a supervised exercise program. In contrast, there are relatively frequent inductions of cardiac arrhythmias, mostly of low complexity, and more rarely, fleeting changes in ventricular repolarization during an IMT session.
2 secondary outcomes
hemodynamic (blood pressure and heart rate) responses
Time frame: one day
electrocardiographic pattern changes
Time frame: one day
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 27 Sep 2013.
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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?
An observational study of Heart Diseases and Lung Disease, run by Clínica de Medicina do Exercício 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 2 inclusion and 1 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 27 Sep 2013. 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?
abnormal clinical responses (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2013.