Clinical Safety for the Inspiratory Muscle Training

NCT ID: NCT01952002

Last Updated: 2013-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Heart Diseases Lung Disease

Keywords

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Blood Pressure heart rate electrocardiogram Cardiac arrhythmias respiratory exercise

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Inspiratory Muscle Training

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clínica de Medicina do Exercício

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinimex - Clínica de Medicina do Exercício

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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304328/2011-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0166.0.000.399-11

Identifier Type: -

Identifier Source: org_study_id