Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

University of Sao Paulo General Hospital

Status: Completed

Conditions: Surgery; Undernutrition

Treatments: Other: Inspiratory muscle training; Other: Sham group; Other: Expiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT02200198

0613/07

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• previous respiratory disease
• necessity of over than 48h of mechanical ventilation
• reoperation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Inspiratory group

Active Comparator group

Description:

Inspiratory muscle training

Treatment:

Other: Inspiratory muscle training

Sham group

Sham Comparator group

Description:

Sham training

Treatment:

Other: Sham group

Expiratory group

Experimental group

Description:

Expiratory muscle training

Treatment:

Other: Expiratory muscle training