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

Primary Purpose

Bariatric Surgery Candidate, Muscle Weakness, Complication,Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training - Powerbreath
Aerobic exercise in cycle ergometer
Deep breathing exercises
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery Candidate focused on measuring bariatric surgery, respiratory muscle strength, pulmonary function, preoperative, postoperative complications

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Centro de Reabilitação StimullusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Incentive Spirometer - The Control Group

Inspiratory muscle training - Powerbreath - The intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.)
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.)
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.

Secondary Outcome Measures

Change over time in Pain
The pain will be measured by visual numeric scale (VNS). The scale ranges from 0 to 10, with 10 being the worst possible pain.

Full Information

First Posted
September 23, 2022
Last Updated
May 8, 2023
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05575089
Brief Title
Inspiratory Muscle Training and Pulmonary Function in Patients Submitted to Bariatric Surgery
Official Title
Pre-operative Inspiratory Muscle Training Effectiveness and Pulmonary Function in Patients Submitted to Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Muscle Weakness, Complication,Postoperative, Respiratory Muscle
Keywords
bariatric surgery, respiratory muscle strength, pulmonary function, preoperative, postoperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incentive Spirometer - The Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inspiratory muscle training - Powerbreath - The intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training - Powerbreath
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise in cycle ergometer
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Deep breathing exercises
Intervention Description
Diaphragmatic exercises ( deep inspirations) associated to raise upper limbs ( 3 times - 10 repetitions each)
Primary Outcome Measure Information:
Title
Change over time in Inspiratory muscle strength - maximum inspiratory pressure (MIP)
Description
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.)
Time Frame
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)
Title
Change over time in Expiratory muscle strength - maximum expiratory pressure (MEP)
Description
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.)
Time Frame
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)
Title
Change over time in Peak Cough Flow (PCF)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change over time in Pain
Description
The pain will be measured by visual numeric scale (VNS). The scale ranges from 0 to 10, with 10 being the worst possible pain.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Accept to participate in the study Age over 18 years Any gender Elective bariatric surgery Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Chiavegato, PHD
Phone
5511984156185
Email
lu_chiavegato@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Monise Silva, master degree student
Email
monisefisio@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana Chiavegato, PHD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Centro de Reabilitação Stimullus
City
Pouso Alegre
State/Province
Minas Geraes
ZIP/Postal Code
37558-443
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monise Silva, Msc
Phone
36462017
Ext
35
Email
monisefisio@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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