Inspiratory Muscle Training After Gastroplasty
This study has been completed.
Sponsor:
University of Sao Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01084447
First received: March 4, 2010
Last updated: March 9, 2010
Last verified: March 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Device: inspiratory muscle training Device: control group |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- Maximum static respiratory pressures [ Time Frame: post-operative days 2, 7, 14, and 30 ] [ Designated as safety issue: No ]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.
- Inspiratory muscular endurance test [ Time Frame: post-operative days 2, 7, 14, and 30. ] [ Designated as safety issue: No ]This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position.
- Spirometric measurements [ Time Frame: post-operative days 2, 7, 14, and 30. ] [ Designated as safety issue: No ]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 Outcome Measures:
- Maximum static respiratory pressures [ Time Frame: post-operative days 2, 7, 14, and 30 ] [ Designated as safety issue: No ]
- Inspiratory muscular endurance test [ Time Frame: post-operative days 2, 7, 14, and 30 ] [ Designated as safety issue: No ]
- Spirometric measurements [ Time Frame: post-operative days 2, 7, 14, and 30. ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | January 2004 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: control group
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
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.
|
|
Active Comparator: trained group
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
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.
Other Name: respiratory training
|
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| Ages Eligible for Study: | 20 Years to 58 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084447
Locations
| Brazil | |
| Faculty of Medicine of Ribeirão Preto, University of Sao Paulo | |
| Ribeirão Preto, São Paulo, Brazil, 14049-900 | |
Sponsors and Collaborators
University of Sao Paulo
Investigators
| Principal Investigator: | Ada C Gastaldi, PHD | Faculty of Medicine of Ribeirao Preto-University of Sao Paulo |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Effect of inspiratory muscle training on muscular and pulmonary function following gastroplasty in obese patients, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01084447 History of Changes |
| Other Study ID Numbers: | USP-2010 |
| Study First Received: | March 4, 2010 |
| Last Updated: | March 9, 2010 |
| Health Authority: | Brasil: Agência Nacional de Vigilância Sanitária (ANVISA) |
Keywords provided by University of Sao Paulo:
|
obesity gastroplasty respiratory muscle training muscle strength physical therapy |
Additional relevant MeSH terms:
|
Respiratory Aspiration Obesity Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Overnutrition Nutrition Disorders Overweight Body Weight |
ClinicalTrials.gov processed this record on June 18, 2013