Clinical Safety for the Inspiratory Muscle Training

Overview

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).

Full Title of Study: “CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2013

Interventions

  • Other: Inspiratory Muscle Training
    • 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • hemodynamic (blood pressure and heart rate) responses
    • Time Frame: one day
  • electrocardiographic pattern changes
    • Time Frame: one day

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Clínica de Medicina do Exercício
  • Provider of Information About this Clinical Study
    • Sponsor

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