Clinical Safety for the Inspiratory Muscle Training

Completed

• Conditions: Lung Disease; Heart Diseases

• Registration Number: NCT01952002
• Lead Sponsor: Clínica de Medicina do Exercício

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-09
• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-24
• Last Update Submitted: 2013-09-24
• Study First Posted: 2013-09-27
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
abnormal clinical responses	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 Outcome Measures

Name	Time	Method
hemodynamic (blood pressure and heart rate) responses	one day
electrocardiographic pattern changes	one day

Trial Locations

Locations (1)

Clinimex - Clínica de Medicina do Exercício; 🇧🇷 Rio de Janeiro, Brazil