Preoperative Inspiratory Muscle Training in Gastroplasty
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
IMT group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Respiratory Muscle Training, Bariatric Surgery, Breathing exercises, Gastroplasty
Eligibility Criteria
Inclusion Criteria:
- patients attending the bariatric surgery's ambulatory;
- patients presenting body mass index (BMI) ≥ 40 kg/m2.
Exclusion Criteria:
- acute or chronic pulmonary diseases;
- smoking;
- not stable cardiovascular diseases;
- decompensated diabetes.
Sites / Locations
- Ribeirão Preto Medicine School, University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IMT group
Control group
Arm Description
The volunteers will do the respiratory muscle training through a linear inspiratory pressure resistance device (POWERbreathe®) at 50% of the maximal inspiratory pressure.
Patients will do a placebo respiratory muscle training through a load pressure resistance device (POWERbreathe®) with the minimum load available (10cmH20).
Outcomes
Primary Outcome Measures
Pulmonary Complications
According to Brooks-Brunn (1997) methodology, pulmonary complications will be considered as: cough/sputum production, abnormal breath sounds, temperature ≥ 38°C, chest radiograph documentation of atelectasis or new infiltrate, physician documentation of atelectasis or pneumonia.
Secondary Outcome Measures
Maximal Static Respiratory Pressures
It has beem used a digital manometer (MVD300, Global Med, São Paulo, Brazil) with graduation ranging from 0 to ± 300 cmH2O and adjusted to a rigid mouthpiece, following the proposed model by Black and Hyatt in 1969.
Inspiratory Muscle Endurance Test
This measurement is performed by using the POWERbreathe® device at 80% maximal inspiratory pressure, following the ATS/ERS recommendations (2002) and Bellemare & Grassino methodology (1982).
Impulse Oscillometry
To perform this measure, it is been used Jaeger® IOS(Jaeger, Wurzburg, Germany) with daily volume and resistance calibration. Data collection happens in different positions: sitting, supine, right lateral decubitus and left lateral decubitus. The parameters are calculated at frequencies between 5 and 35Hz, and will be analyzed the following parameters in this test: resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres).
Pulmonary Function Test
This test is realized by using KoKo Spirometer according ATS/ERS recommendations. The analyzed parameters in this test are: forced vital capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC and FEF25-75%.
Six Minute Walking Test
Patients walk through a 30-meter corridor faster than they can for 6 minutes, according to ATS considerations. The assessed parameters during this test are: blood pressure, cardiac and respiratory frequencies, peripheral oxygen saturation and Borg's Scale.
Dyspnea's Perception
The volunteers answer the mMRC Questionnaire
Life's Quality
The volunteers answer the SF-36 Questionnaire
Level of Physical Activity
The volunteers answer the International Physical Activity Questionnaire (IPAQ).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02478619
Brief Title
Preoperative Inspiratory Muscle Training in Gastroplasty
Official Title
Effects of Preoperative Inspiratory Muscle Training in Patients Undergoing Gastroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the effect of preoperative inspiratory muscle training in patients with grade III obesity undergoing bariatric surgery. It will be a double-blind randomized controlled clinical trial with volunteers allocated in two groups that will be compared according to postoperative evolution (pulmonary complications, lung function, strength and endurance of the respiratory muscles and respiratory system resistance).
Detailed Description
The prevalence of obesity has a significantly increase in recent years and represents a public health problem due to the increased risk of mortality from various causes. Changes in respiratory system arising from obesity are well established and they include a reduction in compliance with an increased ventilatory work and oxygen consumption with breathing. Bariatric surgery is an alternative surgical treatment of obesity and patients who undergo this surgery are susceptible to post operative pulmonary complications as a result of obesity and also abdominal surgery. The inspiratory muscle training (IMT) used in pre or post operative period can improve muscle strength and endurance, beyond the perception of dyspnea.There are suggestions that the preoperative training may contribute to a best post operative evolution in patients, but these benefits are not clearly defined in the literature. The objective is to evaluate the effects of preoperative IMT in post operative patients undergoing gastroplasty. There will be 40 patients of bariatric surgery group in Ribeirão Preto Medical School of both sexes, BMI>40 kg/m2 and with the appropriate inclusion criteria.They will be assessed by pulmonary function tests, measurement of strength and endurance of respiratory muscles, submaximal exercise tests, dyspnea and quality of life scales. All patients will receive standard treatment and will be randomly divided into two groups, named control group and training group, who will be trained for 4 weeks preoperatively. The patients will be reassessed after 4 weeks of training and on the 15th postoperative return day. The evolution data about pulmonary complications will be collected from the medical records, notes of the medical staff and physical therapy routine service.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Respiratory Muscle Training, Bariatric Surgery, Breathing exercises, Gastroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMT group
Arm Type
Active Comparator
Arm Description
The volunteers will do the respiratory muscle training through a linear inspiratory pressure resistance device (POWERbreathe®) at 50% of the maximal inspiratory pressure.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will do a placebo respiratory muscle training through a load pressure resistance device (POWERbreathe®) with the minimum load available (10cmH20).
Intervention Type
Other
Intervention Name(s)
IMT group
Other Intervention Name(s)
Respiratory resistance device (POWERbreathe®)
Intervention Description
Patients will be instructed to do a daily inspiratory muscle training at home with the preset load at 50% of the maximal inspiratory pressure, during 30 minutes for 4 weeks before bariatric surgery.
They will also receive the routine physical therapy in the post operative period.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Patients will be instructed to do a daily inspiratory muscle training at home with the minimal inspiratory load of the respiratory resistance device, during 30 minutes for 4 weeks before bariatric surgery. They will also receive the routine physical therapy in the post operative period.
Primary Outcome Measure Information:
Title
Pulmonary Complications
Description
According to Brooks-Brunn (1997) methodology, pulmonary complications will be considered as: cough/sputum production, abnormal breath sounds, temperature ≥ 38°C, chest radiograph documentation of atelectasis or new infiltrate, physician documentation of atelectasis or pneumonia.
Time Frame
From the first to the 15th post-operative day
Secondary Outcome Measure Information:
Title
Maximal Static Respiratory Pressures
Description
It has beem used a digital manometer (MVD300, Global Med, São Paulo, Brazil) with graduation ranging from 0 to ± 300 cmH2O and adjusted to a rigid mouthpiece, following the proposed model by Black and Hyatt in 1969.
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (6-1 days before /surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
Title
Inspiratory Muscle Endurance Test
Description
This measurement is performed by using the POWERbreathe® device at 80% maximal inspiratory pressure, following the ATS/ERS recommendations (2002) and Bellemare & Grassino methodology (1982).
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (6-1 days before surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
Title
Impulse Oscillometry
Description
To perform this measure, it is been used Jaeger® IOS(Jaeger, Wurzburg, Germany) with daily volume and resistance calibration. Data collection happens in different positions: sitting, supine, right lateral decubitus and left lateral decubitus. The parameters are calculated at frequencies between 5 and 35Hz, and will be analyzed the following parameters in this test: resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres).
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (6-1 days before surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
Title
Pulmonary Function Test
Description
This test is realized by using KoKo Spirometer according ATS/ERS recommendations. The analyzed parameters in this test are: forced vital capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC and FEF25-75%.
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (6-1 days before surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
Title
Six Minute Walking Test
Description
Patients walk through a 30-meter corridor faster than they can for 6 minutes, according to ATS considerations. The assessed parameters during this test are: blood pressure, cardiac and respiratory frequencies, peripheral oxygen saturation and Borg's Scale.
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (6-1 days before surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
Title
Dyspnea's Perception
Description
The volunteers answer the mMRC Questionnaire
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (6-1 days before surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
Title
Life's Quality
Description
The volunteers answer the SF-36 Questionnaire
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (2 days before surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
Title
Level of Physical Activity
Description
The volunteers answer the International Physical Activity Questionnaire (IPAQ).
Time Frame
First evaluation: preoperative / before IMT (4 weeks before surgery); Second evaluation: preoperative / after IMT (2 days before surgery); Third evaluation: postoperative / after IMT (15 days after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients attending the bariatric surgery's ambulatory;
patients presenting body mass index (BMI) ≥ 40 kg/m2.
Exclusion Criteria:
acute or chronic pulmonary diseases;
smoking;
not stable cardiovascular diseases;
decompensated diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada C Gastaldi, PhD
Organizational Affiliation
Ribeirão Preto Medicine School - University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribeirão Preto Medicine School, University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21229331
Citation
Casali CC, Pereira AP, Martinez JA, de Souza HC, Gastaldi AC. Effects of inspiratory muscle training on muscular and pulmonary function after bariatric surgery in obese patients. Obes Surg. 2011 Sep;21(9):1389-94. doi: 10.1007/s11695-010-0349-y.
Results Reference
background
PubMed Identifier
22012043
Citation
Barbalho-Moulim MC, Miguel GP, Forti EM, Campos Fdo A, Costa D. Effects of preoperative inspiratory muscle training in obese women undergoing open bariatric surgery: respiratory muscle strength, lung volumes, and diaphragmatic excursion. Clinics (Sao Paulo). 2011;66(10):1721-7. doi: 10.1590/s1807-59322011001000009.
Results Reference
background
PubMed Identifier
20663275
Citation
Kulkarni SR, Fletcher E, McConnell AK, Poskitt KR, Whyman MR. Pre-operative inspiratory muscle training preserves postoperative inspiratory muscle strength following major abdominal surgery - a randomised pilot study. Ann R Coll Surg Engl. 2010 Nov;92(8):700-7. doi: 10.1308/003588410X12771863936648. Epub 2010 Jul 26.
Results Reference
background
PubMed Identifier
18057088
Citation
Dronkers J, Veldman A, Hoberg E, van der Waal C, van Meeteren N. Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study. Clin Rehabil. 2008 Feb;22(2):134-42. doi: 10.1177/0269215507081574. Epub 2007 Dec 5.
Results Reference
background
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Preoperative Inspiratory Muscle Training in Gastroplasty
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