Skip to content

Inspiratory Muscle Training After Gastroplasty

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01084447
Enrollment
30
Registered
2010-03-10
Start date
2004-01-31
Completion date
2005-08-31
Last updated
2010-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

DEVICEinspiratory 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.

DEVICEcontrol 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.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 58 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum static respiratory pressurespost-operative days 2, 7, 14, and 30This 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.
Inspiratory muscular endurance testpost-operative days 2, 7, 14, and 30.This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position.
Spirometric measurementspost-operative days 2, 7, 14, and 30.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).

Secondary

MeasureTime frame
Maximum static respiratory pressurespost-operative days 2, 7, 14, and 30
Inspiratory muscular endurance testpost-operative days 2, 7, 14, and 30
Spirometric measurementspost-operative days 2, 7, 14, and 30.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026