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

NCT05575089 | Completed

• 1 other identifier: UNICID2021
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. It is associated with a higher frequency of cardiovascular, metabolic diseases, and respiratory morbidities, which affect the quality of life of patients. Its treatment comprises different strategies, however, due the 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.

Conditions

Bariatric Surgery Candidate; Muscle Weakness; Complication,Postoperative; Respiratory Muscle

Keywords

bariatric surgery; respiratory muscle strength; pulmonary function; preoperative; postoperative complications

Outcome Measures

Primary Outcomes (3)

• Change over time in Inspiratory muscle strength - maximum inspiratory pressure (MIP)

  To measure MIP, patients will be instructed to perform a maximal inspiratory effort from residual volume (RV), using a previously calibrated analog manovacuometer (range +/- 300cmH20). The highest value obtained after three repetitions will be recorded. The obtained values will be compared to the predicted values ( Predicted equations by Neder et al.)

  All patients will be assessed at baseline ( protocol admission), in the 10th session of preoperative protocol ( average 30 days), 1st postoperative day ( average 7 days after the last pre op.session) and 30th postoperative day ( 30 days after surgery)

• Change over time in Expiratory muscle strength - maximum expiratory pressure (MEP)

  To measure MEP, patients will be instructed to perform a maximal expiratory effort from total lung capacity (TLC) using a previously calibrated analog manovacuometer (range +/- 300cmH20). The highest value obtained after three repetitions will be recorded. The obtained values will be compared to the predicted values ( Predicted equations by Neder et al.)

  All patients will be assessed at baseline ( protocol admission), in the 10th session of preoperative protocol ( average 30 days), 1st postoperative day ( average 7 days after the last pre op.session) and 30th postoperative day ( 30 days after surgery)

• Change over time in Peak Cough Flow (PCF)

  For PCF measurements, you will be asked to the patients to cough with maximum effort after a deep inspiration using a peak flow meter. The highest value obtained from three repetitions will be recorded. The obtained values will be compared to the predicted values for healthy Brazilian population.

  All patients will be assessed at baseline ( protocol admission), in the 10th session of preoperative protocol ( average 30 days), 1st postoperative day ( average 7 days after the last pre op.session) and 30th postoperative day ( 30 days after surgery)

Secondary Outcomes (1)

• Change over time in Pain

  All patients will be assessed at baseline ( protocol admission), in the 10th session of preoperative protocol ( average 30 days), 1st postoperative day ( average 7 days after the last pre op.session) and 30th postoperative day ( 30 days after surgery)

Study Arms (2)

Incentive Spirometer - The Control Group

ACTIVE COMPARATOR

The control group will receive an aerobic exercise in the cycle ergometer that will be conducted on a cycle ergometer divided into three steps: heat 5 minutes; 20 minutes with a confortable speed ( individuallyprescribed) and 5 minutes recovery. They will also perform active respiratory exercises, and incentive spirometer during 10 face-to-face physical therapy sessions. They will be instructed to do exercises with incentive spirometer at home, 3 times a day with 30 to 40 repetitions, during all preoperative period. The patients will receive a diary to note the exercises frequency.

Other: Aerobic exercise in cycle ergometer; Other: Deep breathing exercises

Inspiratory muscle training - Powerbreath - The intervention group

EXPERIMENTAL

This intervention group will receive the same control group protocol: aerobic exercise in cycle ergometer, divided into three steps: heat 5 minutes; 20 minutes with a confortable speed ( individually prescribed) and 5 minutes recovery and active respiratory exercises ( deep inspirations associated to raise upper limbs ( 3 times of 10 repetitions each), and, in addition, inspiratory muscle training with Powerbreath during 10 face-to-face physical therapy sessions. They will be instructed to do exercises with Powerbreath at home, 3 times a day with 30 to 40 repetitions, inspiratory load: 60% of MIP ( first evaluation - protocol admission) during all preoperative period. The patients will receive a diary to note the exercises frequency.

Device: Inspiratory muscle training - Powerbreath; Other: Aerobic exercise in cycle ergometer; Other: Deep breathing exercises

Interventions

Inspiratory muscle training - Powerbreath DEVICE

The device "Powerbreath" is an inspiratory muscle training used to train respiratory muscles. Currently, it is one of the most used devices for the TMI, a linear load model with continuous application of inspiratory pressure throughout inspiration, in which the inspiratory regulating valve remains open while allowing an unrestricted expiration that generates resistance through a spring or of an electronic valve system, ability to offer greater load during training.

Inspiratory muscle training - Powerbreath - The intervention group

Aerobic exercise in cycle ergometer OTHER

10 face-to-face non consecutive sessions with 30 minutes in a cycle ergometer(divided into three steps: heat 5 minutes; 20 minutes with a comfortable and supportable speed or load ( individually prescribed) and 5 minutes recovery

Incentive Spirometer - The Control Group; Inspiratory muscle training - Powerbreath - The intervention group

Deep breathing exercises OTHER

Diaphragmatic exercises ( deep inspirations) associated to raise upper limbs ( 3 times - 10 repetitions each)

Incentive Spirometer - The Control Group; Inspiratory muscle training - Powerbreath - The intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accept to participate in the study
• Age over 18 years
• Any gender
• Elective bariatric surgery

You may not qualify if:

• Mechanical ventilation for more than 48 hours after the surgical procedure
• Hemodynamic instability at the time of the first evaluation and persistent in the evaluation after 1 hour

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Centro de Reabilitação Stimullus

Pouso Alegre, Minas Gerais, 37558-443, Brazil

Location

MeSH Terms

Conditions

Muscle Weakness; Postoperative Complications

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luciana Chiavegato, PHD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD, Professor of Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 12, 2022
• Study Start: November 15, 2022
• Primary Completion: July 5, 2023
• Study Completion: June 7, 2024
• Last Updated: December 9, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)