Overview

This trial is active, not recruiting.

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
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
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
maximum inspiratory pressure
time frame: After 4 weeks follow

Secondary Outcomes

Measure
Maximum volume ventilation
time frame: After 4 weeks follow

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Patients older than 18 years; - Admitted to the surgical ward in preoperative care; - Consent to participate in the intervention protocol, blinding and randomization. Exclusion Criteria: - Patients with cognitive impairment to perform the respiratory training; - Patients with cardiac arrhythmias uncontrolled, circulatory shock, acute ischemic heart disease; - Patients with acute respiratory failure, considered by arterial oxygen tension (PaO 2) less than 60 mmHg in room air or arterial carbon dioxide (PaCO2) greater than 50 mmHg; - Patients who were discharged before the conclusion of the Protocol; - Patients with neuromuscular disease or myopathies, diaphragmatic paralysis or paresis; - Patients receiving respiratory therapy load (inspiratory or expiratory), parallel to the protocol; - Patients requiring MV for more than 48 consecutive hours.

Additional Information

Official title Impact of Inspiratory Muscle Training Using Powerbreathe in Maximum Inspiratory Pressure of Hospiralized Patients
Description Randomized Clinical Trial (RCT), triple blind, performed in a public hospital in the city of Salvador in Bahia, patients with prolonged hospitalization. Submitted to TMI for four weeks. Prior to the study, it was conducted pilot study to standardize the implementation of the assistance and slapping the wards with higher rates of stay. Thus, the study was conducted with all patients admitted to the surgical ward of the hospital, admitted since pre-operative care, to respect the inclusion criteria. Subjecting them to the intervention protocol for 4 weeks from the admission and follow-up of outcomes of interest to hospital. It was performed sample size calculations with Software GPower® considering a statistical power of 80%, with 5% alpha. To ensure that all patients had the same chance of inclusion among the groups was carried out systematic random randomization, used the Software randList. Upon review of preliminary results, the randomization into strata was carried out for age and gender.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Federal University of Bahia.