Inspiratory Muscle Training After Gastroplasty

NCT01084447 | Completed Phase 1 DMC

• 1 other identifier: USP-2010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity; gastroplasty; respiratory muscle training; muscle strength; physical therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

Study Arms (2)

control group

PLACEBO COMPARATOR

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

trained group

ACTIVE COMPARATOR

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

Interventions

inspiratory muscle training DEVICE

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.

Also known as: respiratory training

trained group

control group DEVICE

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.

control group

Eligibility Criteria

• Age: 20 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• gastroplasty patients presenting body mass index (BMI) ≥ 35 kg/m2;
• weighting ≤ 60 kg/m2;
• capable of fulfilling the experimental protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculty of Medicine of Ribeirão Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (3)

• Christensen EF, Schultz P, Jensen OV, Egebo K, Engberg M, Gron 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. doi: 10.1111/j.1399-6576.1991.tb03255.x.

  PMID: 2024569 BACKGROUND

• 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.

  PMID: 18057088 BACKGROUND

• 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.

  PMID: 21229331 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Breathing Exercises; Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ada C Gastaldi, PHD

  Faculty of Medicine of Ribeirao Preto-University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 10, 2010
• Study Start: January 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2005
• Last Updated: March 10, 2010

Record last verified: 2010-03

Locations

BR (1)