Obesity Clinical Trial
Official title:
Effects of Preoperative Inspiratory Muscle Training in Patients Undergoing Gastroplasty
Verified date | June 2015 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | July 2017 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Ribeirão Preto Medicine School, University of São Paulo | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
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. — View 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. — View 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. Epub 2007 Dec 5. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From the first to the 15th post-operative day | No |
Secondary | 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. | 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) | No |
Secondary | 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). | 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) | No |
Secondary | 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). | 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) | No |
Secondary | 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%. | 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) | No |
Secondary | 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. | 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) | No |
Secondary | Dyspnea's Perception | The volunteers answer the mMRC Questionnaire | 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) | No |
Secondary | Life's Quality | The volunteers answer the SF-36 Questionnaire | 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) | No |
Secondary | Level of Physical Activity | The volunteers answer the International Physical Activity Questionnaire (IPAQ). | 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) | No |
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