Preoperative Inspiratory Muscle Training in Gastroplasty

NCT ID: NCT02478619

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IMT group

The volunteers will do the respiratory muscle training through a linear inspiratory pressure resistance device (POWERbreathe®) at 50% of the maximal inspiratory pressure.

Group Type: ACTIVE_COMPARATOR

IMT group

Intervention Type: OTHER

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.

Control group

Patients will do a placebo respiratory muscle training through a load pressure resistance device (POWERbreathe®) with the minimum load available (10cmH20).

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: OTHER

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.

Interventions

IMT group

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

Control group

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.

Intervention Type: OTHER

Other Intervention Names

Respiratory resistance device (POWERbreathe®)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ada Clarice Gastaldi

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ada C Gastaldi, PhD

Role: PRINCIPAL_INVESTIGATOR

Ribeirão Preto Medicine School - University of São Paulo

Locations

Ribeirão Preto Medicine School, University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 21229331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22012043 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20663275 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18057088 (View on PubMed)

Other Identifiers

USP 2015-2

Identifier Type: -

Identifier Source: org_study_id