Chest Physiotherapy After Bariatric Aurgery - A Compariso... | NCT00678678

Studies
Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)

NCT00678678

Sponsor

Universidade Metodista de Piracicaba

Status

Completed

Last Update Posted

May 15, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Obesity

Interventions

Incentive Spirometry - RESPIRON
Kit Epap®:

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 29, 2008

First Submission Date that Met QC Criteria

May 13, 2008

First Posted Date

May 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2008

Last Update Posted Date

May 15, 2008Estimated

Description Module

Brief Summary

Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in the pulmonary function after bariatric surgery.

Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2, undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion, on the preoperative and on the second postoperative day. Physiotherapy started on the day of surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The deambulation and active exercises of upper and lower limbs were standardized for groups.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I - Spirometer	Active Comparator		Device: Incentive Spirometry - RESPIRON
II - Kit Epap®	Active Comparator	Device with Spring load by mask,produced by Brazil (critical med)	Device: Kit Epap®:

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Incentive Spirometry - RESPIRON	Device	Device that stimulates the deep breathing, flow-oriented	I - Spirometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion		preoperative and second postoperative day

Secondary Outcomes

Measure	Description	Time Frame
Hospital stay and postoperative pulmonary complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obese with body mass index between: 35 e 50 kg/m2
Non-smokers
No lung disease

Exclusion Criteria:

Unable to perform the evaluation tests
Not signed the consentment term

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Meridional Hospital		Cariacica	Espírito Santo	29101-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

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Browse Branches

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