NCT01952002|Completed
Clinical Safety for the Inspiratory Muscle Training
CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM
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CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · CNPq
observational
21
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Actual (reported)June 2013
Actual (reported)September 23, 2013
Actual (reported)September 27, 2013
Actual (reported)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
hemodynamic (blood pressure and heart rate) responses
one day
electrocardiographic pattern changes
one day
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients regularly attending a supervised exercise program
Clinimex - Clínica de Medicina do Exercício
Rio de Janeiro, Rio de Janeiro, 22031-070, Brazil
21 participants (actual enrollment reported by the registry).
First Submitted
September 23, 2013
First Posted
September 27, 2013
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.
Contact the study team to confirm eligibility.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
September 27, 2013
Record last verified: 2013-09
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Source: ClinicalTrials.gov.
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