Overview

This trial has been completed.

Condition muscle weakness
Treatments powerbreathe, physiotherapy
Sponsor Federal University of Bahia
Start date May 2015
End date February 2016
Trial size 54 participants
Trial identifier NCT02459444, U1111-1163-0679

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, outcomes assessor
Arm
(Experimental)
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.
powerbreathe MODEL: CLASSIC LIGHT RESISTANCE
Respiratory equipment for physiotherapy, offering to load muscles inspiratory
physiotherapy Concurrent training
This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.
(Placebo Comparator)
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.
physiotherapy Concurrent training
This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.

Primary Outcomes

Measure
hospital inpatient complications
time frame: Discharge from hospital

Secondary Outcomes

Measure
respiratory muscle strength
time frame: After 4 weeks follow

Eligibility Criteria

All participants from 18 years up to 60 years old.

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.

Additional Information

Official title Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Federal University of Bahia.