Clinical Safety for the Inspiratory Muscle Training

NCT01952002 | Completed

• 2 other identifiers: 0166.0.000.399-11304328/2011-1
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Diseases; Lung Disease

Keywords

Blood Pressure; heart rate; electrocardiogram; Cardiac arrhythmias; respiratory exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• hemodynamic (blood pressure and heart rate) responses

  one day

• electrocardiographic pattern changes

  one day

Study Arms (1)

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

Other: Inspiratory Muscle Training

Interventions

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

IMT - Inspiratory Muscle Training

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients regularly attending a supervised exercise program

You may qualify if:

• Patients regularly attending a supervised exercise program
• Patients were already performing the IMT in their usual supervisioned exercise sessions

You may not qualify if:

• cognitive impairment

Sponsors & Collaborators

• Clínica de Medicina do Exercício: lead

Study Sites (1)

Clinimex - Clínica de Medicina do Exercício

Rio de Janeiro, Rio de Janeiro, 22031-070, Brazil

Location

MeSH Terms

Conditions

Heart Diseases; Lung Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 27, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 27, 2013

Record last verified: 2013-09

Locations

BR (1)