Inspiratory Muscle Training After Gastroplasty

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of post-operative inspiratory muscle training on muscle strength and endurance in patients with obesity submitted to gastroplasty.

Detailed Description
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Gastroplasties, like other major abdominal surgeries, induce mechanical changes in the lungs and decreases of the respiratory muscle strength in the post-operative periods. Depending on the occurrence of pre-existing disturbs, obese patients may exhibit severe declines of respiratory function after these surgeries. Post-operative respiratory physiotherapy is a valuable intervention, involving a set of techniques aimed to expand pulmonary volumes and to improve arterial oxygenation, leading to decreases on the development of atelectasis and pneumonias. It induces faster recovery of respiratory function and reduction of lung complications, what may be particularly important in high-risk patients like over-weighted subjects. There are scanty data about the role of respiratory muscle training in the post-operative period. This is particularly true regarding inspiratory muscle training of obese patients submitted to gastroplasties.

Official Title
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Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients

Conditions
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Obesity

Intervention / Treatment
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* Device: inspiratory muscle training
* Device: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gastroplasty patients presenting body mass index (BMI) ≥ 35 kg/m2; weighting ≤ 60 kg/m2; capable of fulfilling the experimental protocol. Exclusion Criteria: acute or chronic pulmonary disease; smoking; post-operative mechanical ventilation for more than 48 hours; presence of lung complications; need for surgical re-intervention during the study period.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>In placebo muscular training group the respiratory exercise was used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA) no load. | Device: control group<br>* In placebo muscular training the daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)no load until the 30th post-operative day.<br>|
| Active Comparator: trained group<br>In trained group the respiratory exercise used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)the load was initially set at 40% of the maximal inspiratory pressure. | Device: inspiratory muscle training<br>* This daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)was initially set at 40% of the maximal inspiratory pressure, obtained in the 2nd post-operative day, being adjusted to every new maximal inspiratory pressure measurement.<br>* Other names: respiratory training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum static respiratory pressures | This measurement was made at mouth level by using a properly calibrated manovacuometer (GERAR ®, São Paulo, Brazil), with graduation ranging from 0 to ± 300 cmH2O, connected to a rigid plastic tube. | post-operative days 2, 7, 14, and 30 | 
| Inspiratory muscular endurance test | This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position. | post-operative days 2, 7, 14, and 30. | 
| Spirometric measurements | Spirometry was performed according to norms of the American Thoracic Society (ATS) (1994)19 by using a previously calibrated spirometer (Respiradyne II Plus®, Sherwood Medical, St. Louis, USA). | post-operative days 2, 7, 14, and 30. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum static respiratory pressures |  | post-operative days 2, 7, 14, and 30 | 
| Inspiratory muscular endurance test |  | post-operative days 2, 7, 14, and 30 | 
| Spirometric measurements |  | post-operative days 2, 7, 14, and 30. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, gastroplasty, respiratory muscle training, muscle strength, physical therapy