Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-06-30

Brief Summary

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Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. How the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.

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Detailed Description

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Conditions

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Undernutrition Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Inspiratory group

Inspiratory muscle training

Group Type ACTIVE_COMPARATOR

Inspiratory muscle training

Intervention Type OTHER

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor

Sham group

Sham training

Group Type SHAM_COMPARATOR

Sham group

Intervention Type OTHER

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load

Expiratory group

Expiratory muscle training

Group Type EXPERIMENTAL

Expiratory muscle training

Intervention Type OTHER

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor

Interventions

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Expiratory muscle training

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor

Intervention Type OTHER

Inspiratory muscle training

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor

Intervention Type OTHER

Sham group

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* hospitalized malnourished patients (BMI ≤ 20 Kg/m2, loss of body weight ≥ 10% unintentional, or serum albumin \<3.5 g/dL)
* candidate to elective abdominal surgery
* ability to perform all evaluations and training