Clinical trial NCT01084447: Inspiratory Muscle Training After Gastroplasty
Official title: Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: obesity
gastroplasty
respiratory muscle training
muscle strength
physical therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum static respiratory pressures
timeFrame: post-operative days 2, 7, 14, and 30
measure: Inspiratory muscular endurance test
timeFrame: post-operative days 2, 7, 14, and 30.
measure: Spirometric measurements
timeFrame: post-operative days 2, 7, 14, and 30.
Secondary outcomes:
measure: Maximum static respiratory pressures
timeFrame: post-operative days 2, 7, 14, and 30
measure: Inspiratory muscular endurance test
timeFrame: post-operative days 2, 7, 14, and 30
measure: Spirometric measurements
timeFrame: post-operative days 2, 7, 14, and 30.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
state: São Paulo
Study officials:
affiliation: Faculty of Medicine of Ribeirao Preto-University of Sao Paulo
name: Ada C Gastaldi, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1177/0269215507081574. Epub 2007 Dec 5.
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.