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Clinical Safety for the Inspiratory Muscle Training

CLINICAL SAFETY FOR THE INSPIRATORY MUSCLE TRAINING IN CARDIOPULMONARY REHABILITATION PROGRAM

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01952002
Enrollment
21
Registered
2013-09-27
Start date
2012-10-31
Completion date
2013-06-30
Last updated
2013-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases, Lung Disease

Keywords

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

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).

Interventions

OTHERInspiratory 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

Sponsors

Clínica de Medicina do Exercício
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
abnormal clinical responsesOne dayDuring 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

MeasureTime frame
hemodynamic (blood pressure and heart rate) responsesone day
electrocardiographic pattern changesone day

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026