Clinical Safety for the Inspiratory Muscle Training

Heart Diseases Clinical Trial

Official title:

CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952002
• Other study ID #: 0166.0.000.399-11
• Secondary ID: 304328/2011-1
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: September 24, 2013
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Clínica de Medicina do Exercício
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Diseases
• Lung Disease
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Clinimex - Clínica de Medicina do Exercício	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Clínica de Medicina do Exercício

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	hemodynamic (blood pressure and heart rate) responses		one day	Yes
Secondary	electrocardiographic pattern changes		one day	Yes