Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

NCT02200198 | Completed

• 1 other identifier: 0613/07
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Undernutrition; Surgery

Keywords

undernutrition; abdominal surgery; respiratory muscles; muscles strength; pulmonary complication; perioperative care

Outcome Measures

Primary Outcomes (1)

• Expiratory peak flow in spirometry

  Assessed as expiratory peak flow in spirometry

  on the 8th day of protocol (after 7 dyas of training)

Secondary Outcomes (2)

• Maximum respiratory pressures

  on the 8th day of protocol (after 7 days of training)

• Postoperative pulmonary complication

  participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days

Study Arms (3)

Inspiratory group

ACTIVE COMPARATOR

Inspiratory muscle training

Other: Inspiratory muscle training

Sham group

SHAM COMPARATOR

Sham training

Other: Sham group

Expiratory group

EXPERIMENTAL

Expiratory muscle training

Other: Expiratory muscle training

Interventions

Expiratory muscle training OTHER

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

Expiratory group

Inspiratory muscle training OTHER

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

Inspiratory group

Sham group OTHER

Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital of Clinics of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Celso RF Carvalho, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: February 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

BR (1)