Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

Not Applicable

Completed

• Conditions: Undernutrition; Surgery
• Interventions: Other: Sham group; Other: Inspiratory muscle training; Other: Expiratory muscle training

• Registration Number: NCT02200198
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-24
• Last Update Submitted: 2014-07-24
• Study First Posted: 2014-07-25
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	Sham group	Sham training
Inspiratory group	Inspiratory muscle training	Inspiratory muscle training
Expiratory group	Expiratory muscle training	Expiratory muscle training

Primary Outcome Measures

Name	Time	Method
Expiratory peak flow in spirometry	on the 8th day of protocol (after 7 dyas of training)	Assessed as expiratory peak flow in spirometry

Secondary Outcome Measures

Name	Time	Method
Maximum respiratory pressures	on the 8th day of protocol (after 7 days of training)	Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure
Postoperative pulmonary complication	participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days	The following pulmonary complications were considered: atelectasis with clinical consequences, hypoxemia with oxygen saturation \<85%, and need for supplemental oxygen, pneumonia and acute respiratory failure.; The diagnosis of complication was performed by a physician who was blinded to the intervention group.

Trial Locations

Locations (1)

Hospital of Clinics of Sao Paulo; 🇧🇷 Sao Paulo, Brazil