Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

July 24, 2014 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Hospital of Clinics of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expiratory peak flow in spirometry
Time Frame: on the 8th day of protocol (after 7 dyas of training)
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
Time Frame: 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
on the 8th day of protocol (after 7 days of training)
Postoperative pulmonary complication
Time Frame: 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.
participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Director: Celso RF Carvalho, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0613/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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