Inspiratory Muscle Training and Pulmonary Function in Patients Submitted to Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title: Pre-operative Inspiratory Muscle Training Effectiveness and Pulmonary Function in Patients Submitted to Bariatric Surgery

Status Recruiting

Clinical Trial Summary

Obesity is defined as a body mass index greater than or equal to 30 kg / m2 and represents a public health problem that affects the world population. Because it affects several organ systems, obesity is associated with a higher frequency of cardiovascular, metabolic diseases, and respiratory morbidities, which substantially affect the quality of life of patients. The treatment of obesity comprises different strategies, however, in view of the little success with more conventional treatments, surgical treatment has been the most sought after today. Objectives: To evaluate the effectiveness of preoperative inspiratory muscle training in the evolution of respiratory muscle strength in patients undergoing bariatric surgery. Methodology: Randomized clinical trial. All patients will be assessed in the pre operative period and randomized into 2 groups: control group and intervention group. The main variables are maximum inspiratory and expiratory muscle strength (MIP and MEP), peak cough flow (PCF) and pain. Control group will perform proposed respiratory physiotherapy, aerobic exercises and use of incentive inspirometry, the intervention group will perform proposed physiotherapy, aerobic exercises and use of Powerbreathe for inspiratory muscle training. Both groups will perform 10 non consecutive face-to-face physiotherapy sessions ( up 30 days before surgery). After the surgical intervention, they will be evaluated on the first and 30th postoperative days in relation to the same variables and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. After the intervention, they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. After the intervention, they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. Categorical variables will be summarized in absolute and relative frequencies (percentages). Information regarding numerical variables will be expressed as means, standard deviations or medians, and interquartile range, depending on the distribution of the variable. All variables will be tested in relation to their distribution. To analyze the results between groups will be used the mixed linear models and for intragroup analysis, two-way ANOVA (time and group) for the following variables: MIP and MEP, PCF and pain. Expected results: Preoperative inspiratory muscle training can maintain/improve respiratory muscle strength until the moment prior to surgery, thus better preparing the patient for the condition of surgical stress, in addition to decreasing the incidence of pulmonary complications during the hospitalization period and / or in the 30 postoperative days.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Complication,Postoperative
• Muscle Weakness
• Postoperative Complications
• Respiratory Muscle

• NCT number: NCT05575089
• Study type: Interventional
• Source: Universidade Cidade de Sao Paulo
• Contact: Luciana Chiavegato, PHD
• Phone: 5511984156185
• Email: lu_chiavegato@uol.com.br
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Completion date: January 31, 2024