Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

Study Overview
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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.

Official Title
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Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery

Conditions
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Undernutrition, Surgery

Intervention / Treatment
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* Other: Expiratory muscle training
* Other: Inspiratory muscle training
* Other: Sham group


Participation Criteria
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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 Exclusion Criteria: previous respiratory disease necessity of over than 48h of mechanical ventilation reoperation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inspiratory group<br>Inspiratory muscle training | Other: Inspiratory muscle training<br>* 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<br>|
| Sham Comparator: Sham group<br>Sham training | Other: Sham group<br>* Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load<br>|
| Experimental: Expiratory group<br>Expiratory muscle training | Other: Expiratory muscle training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expiratory peak flow in spirometry | Assessed as expiratory peak flow in spirometry | on the 8th day of protocol (after 7 dyas of training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum respiratory pressures | Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure | on the 8th day of protocol (after 7 days of training) | 
| Postoperative pulmonary complication | 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. | participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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undernutrition, abdominal surgery, respiratory muscles, muscles strength, pulmonary complication, perioperative care