Inspiratory Muscle Training After Gastroplasty

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084447
• Other study ID #: USP-2010
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2010
• Last updated: March 9, 2010
• Start date: January 2004
• Est. completion date: August 2005

Study information

• Verified date: March 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brasil: Agência Nacional de Vigilância Sanitária (ANVISA)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2005
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 58 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• inspiratory muscle training
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.
• control group
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.

Locations

Country	Name	City	State
Brazil	Faculty of Medicine of Ribeirão Preto, University of Sao Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Christensen EF, Schultz P, Jensen OV, Egebo K, Engberg M, Grøn I, Juhl B. Postoperative pulmonary complications and lung function in high-risk patients: a comparison of three physiotherapy regimens after upper abdominal surgery in general anesthesia. Acta Anaesthesiol Scand. 1991 Feb;35(2):97-104. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.	No
Primary	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.	No
Secondary	Maximum static respiratory pressures		post-operative days 2, 7, 14, and 30	No
Secondary	Inspiratory muscular endurance test		post-operative days 2, 7, 14, and 30	No
Secondary	Spirometric measurements		post-operative days 2, 7, 14, and 30.	No