Inspiratory Muscle Training and Hospital Complications

Study Overview
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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.

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.

Official Title
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Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization

Conditions
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Muscle Weakness

Intervention / Treatment
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* Device: Powerbreathe
* Other: Physiotherapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT group and physiotherapy<br>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. | Device: Powerbreathe<br>* Respiratory equipment for physiotherapy, offering to load muscles inspiratory<br>* Other names: MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOM;Other: Physiotherapy<br>* This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.<br>* Other names: Concurrent training;|
| Placebo Comparator: Sham IMT group<br>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. | Other: Physiotherapy<br>* This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.<br>* Other names: Concurrent training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital inpatient complications | Follow-up during hospitalization | Discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory muscle strength | Measured with manometer for 3 reps. | After 4 weeks follow | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Muscles, Muscle Weakness, Hospitalization, Length of Stay, Mortality