ObesityNCT00678678
Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)
A study testing Incentive Spirometry - RESPIRON and Kit Epap®: in people with Obesity, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Incentive Spirometry - RESPIRON and Kit Epap®:
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese with body mass index between: 35 e 50 kg/m2
- Non-smokers
- No lung disease
Who cannot join
- Unable to perform the evaluation tests
- Not signed the consentment term
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chest Physiotherapy After Bariatric Surgery - a Comparison Between Incentive Spirometry and Epap
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.
- Conditions
- Obesity
- Being tested
- Incentive Spirometry - RESPIRON, Kit Epap®:
- Keywords
- Physiotherapy, Breathing exercises, Bariatric Surgery, Laparoscopy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive Spirometry - RESPIRONDevice
Device that stimulates the deep breathing, flow-oriented
Kit Epap®:Device
Also called EPAP - End positive airway pressure, Spring Load by mask
Device that providing constant positive pressure during expiration, given by spring load (cmH2O), using a face mask as an interface
| Study group | Role | What they receive |
|---|---|---|
| I - Spirometer | Active comparator | Not described Receives: Device: Incentive Spirometry - RESPIRON |
| II - Kit Epap® | Active comparator | Device with Spring load by mask,produced by Brazil (critical med) Receives: Device: Kit Epap®: |
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion
Measured: preoperative and second postoperative day
Secondary outcomes (1)
Hospital stay and postoperative pulmonary complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678678
- Sponsor's protocol ID
- 01/07
- Status last verified
- Apr 2008
- First submitted
- 29 Apr 2008
- Last updated
- 15 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Physiotherapy After Bariatric Surgery - a Comparison Between Incentive Spirometry and Epap
- ClinicalTrials.gov ID
- NCT00678678
- Acronym / sponsor ID
- 01/07
- Conditions
- Obesity
- Keywords
- Physiotherapy, Breathing exercises, Bariatric Surgery, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I - Spirometer | Active comparator | Device: Incentive Spirometry - RESPIRON |
| II - Kit Epap® | Active comparator | Device: Kit Epap®:Device with Spring load by mask,produced by Brazil (critical med) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese with body mass index between: 35 e 50 kg/m2
- Non-smokers
- No lung disease
Key exclusion criteria (2 listed)
- Unable to perform the evaluation tests
- Not signed the consentment term
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive Spirometry - RESPIRONDevice that stimulates the deep breathing, flow-oriented | Device | I - Spirometer |
| Kit Epap®:Also: EPAP - End positive airway pressure, Spring Load by maskDevice that providing constant positive pressure during expiration, given by spring load (cmH2O), using a face mask as an interface | Device | II - Kit Epap® |
Primary outcome
spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion
Time frame: preoperative and second postoperative day
1 secondary outcome
Hospital stay and postoperative pulmonary complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometry - RESPIRON and Kit Epap®: in people with Obesity, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion (time frame: preoperative and second postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2008.