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Completed

NCT Number: NCT01952002

Clinical Safety for the Inspiratory Muscle Training

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).

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Key information

Conditions

Heart Diseases Arrhythmias, Cardiac Cardiovascular Diseases Lung Disease Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinimex - Clínica de Medicina do Exercício

Rio de Janeiro, 22031-070, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

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

Primary outcomes

  1. 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 outcomes

  1. hemodynamic (blood pressure and heart rate) responses

    Time frame: one day

  2. electrocardiographic pattern changes

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Clínica de Medicina do Exercício

Other

Registry information

Official study title

CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2013
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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