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Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02200198
Enrollment
45
Registered
2014-07-25
Start date
2011-02-28
Completion date
2014-06-30
Last updated
2014-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery, Undernutrition

Keywords

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

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.

Interventions

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

OTHERInspiratory 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

OTHERSham group

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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Expiratory peak flow in spirometryon the 8th day of protocol (after 7 dyas of training)Assessed as expiratory peak flow in spirometry

Secondary

MeasureTime frameDescription
Maximum respiratory pressureson 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 complicationparticipants will be followed for the duration of hospital stay after surgery, an expected average of 10 daysThe 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026