Inspiratory Muscle Training and Hospital Complications

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

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-08-31

Brief Summary

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The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and athletes, your goal is to recondition the respiratory muscles, providing optimization of lung capacity, either for high performance sport as to support metabolic wear caused by illness. It is generally agreed the positive impact of the application of a TMI Protocol on maximal inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the muscle; the specificity of training; the reversibility of the gain and muscle atrophy.

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Detailed Description

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This prospective double-blind (patient and evaluator) randomised controlled trial compared the efficacy of inspiratory muscle training and inspiratory muscle training. The study protocol for this trial was described elsewhere. This study was conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial was performed at the Roberto Santos General Hospital in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 03/2014). Before enrolment, written informed consent was obtained from participants or their legal guardians.

Conditions

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Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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IMT group and physiotherapy

Inspiratory muscle training with POWERBREATHE an approximate load of 50 % of MIP , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program.

Group Type EXPERIMENTAL

Powerbreathe

Intervention Type DEVICE

Respiratory equipment for physiotherapy, offering to load muscles inspiratory

Physiotherapy

Intervention Type OTHER

This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.

Sham IMT group

Inspiratory muscle training with the same device in the experimental group , however without charge , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program.

Group Type PLACEBO_COMPARATOR

Physiotherapy

Intervention Type OTHER

This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.

Interventions

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Powerbreathe

Respiratory equipment for physiotherapy, offering to load muscles inspiratory

Intervention Type DEVICE

Physiotherapy

This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.

Intervention Type OTHER

Other Intervention Names

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MODEL: CLASSIC LIGHT RESISTANCE ANVISA: CLASS I 81001390001 MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOM Concurrent training

Eligibility Criteria

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Inclusion Criteria

* Admission to the hospital ward;
* At least two of the following risk factors for prolonged hospitalization: two or more comorbidities; sepsis; liver, lung, or kidney diseases; neoplasia; mechanical ventilation; and use of vasopressor or dialysis therapy.

Exclusion Criteria

* Patients with a cognitive disability that made them unable to perform the respiratory training;
* Uncontrolled cardiac arrhythmias;
* Circulatory shock;
* Acute ischemic heart disease;
* acute respiratory failure (characterised by a partial pressure of arterial oxygen \< 60 mmHg or a partial pressure of arterial carbon dioxide \> 50 mmHg);
* neuromuscular disease or myopathies;
* diaphragmatic paresis or paralysis were excluded from the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No