Inspiratory Muscle Training After Gastroplasty

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Device: inspiratory muscle training; Device: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01084447

USP-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 58 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

In placebo muscular training group the respiratory exercise was used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA) no load.

Treatment:

Device: control group

trained group

Active Comparator group

Description:

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.

Treatment:

Device: inspiratory muscle training