Clinical Safety for the Inspiratory Muscle Training

Study Overview
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Brief Summary
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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).

Official Title
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CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM

Conditions
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Heart Diseases, Lung Disease

Intervention / Treatment
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* Other: Inspiratory Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients regularly attending a supervised exercise program Patients were already performing the IMT in their usual supervisioned exercise sessions Exclusion Criteria: cognitive impairment

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IMT - Inspiratory Muscle Training<br>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 | Other: Inspiratory Muscle Training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic (blood pressure and heart rate) responses |  | one day | 
| electrocardiographic pattern changes |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, heart rate, electrocardiogram, Cardiac arrhythmias, respiratory exercise