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Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

Primary Purpose

Undernutrition, Surgery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Expiratory muscle training
Inspiratory muscle training
Sham group
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Undernutrition focused on measuring undernutrition, abdominal surgery, respiratory muscles, muscles strength, pulmonary complication, perioperative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital of Clinics of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Experimental

Arm Label

Inspiratory group

Sham group

Expiratory group

Arm Description

Inspiratory muscle training

Sham training

Expiratory muscle training

Outcomes

Primary Outcome Measures

Expiratory peak flow in spirometry
Assessed as expiratory peak flow in spirometry

Secondary Outcome Measures

Maximum respiratory pressures
Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure
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.

Full Information

First Posted
July 23, 2014
Last Updated
July 24, 2014
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02200198
Brief Title
Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery
Official Title
Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Surgery
Keywords
undernutrition, abdominal surgery, respiratory muscles, muscles strength, pulmonary complication, perioperative care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory group
Arm Type
Active Comparator
Arm Description
Inspiratory muscle training
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Sham training
Arm Title
Expiratory group
Arm Type
Experimental
Arm Description
Expiratory muscle training
Intervention Type
Other
Intervention Name(s)
Expiratory muscle training
Intervention Description
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
Intervention Name(s)
Inspiratory muscle training
Intervention Description
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
Intervention Name(s)
Sham group
Intervention Description
Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load
Primary Outcome Measure Information:
Title
Expiratory peak flow in spirometry
Description
Assessed as expiratory peak flow in spirometry
Time Frame
on the 8th day of protocol (after 7 dyas of training)
Secondary Outcome Measure Information:
Title
Maximum respiratory pressures
Description
Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure
Time Frame
on the 8th day of protocol (after 7 days of training)
Title
Postoperative pulmonary complication
Description
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.
Time Frame
participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Hospital of Clinics of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

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Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

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