Preoperative Inspiratory Muscular TrainingNCT01321983
Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery
A study testing Inspiratory muscular training - IMT in people with Preoperative Inspiratory Muscular Training and Bariatric Surgery, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Preoperative Inspiratory Muscular Training, Bariatric Surgery, Chest Physiotherapy
- What is being tested?
- Inspiratory muscular training - IMT
- 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
- Adult, Older adult
Who may be able to join
- Female,
- Over 18 years of age,
- No smoking or respiratory disease.
Who cannot join
- Patients who refused to participate in the steps of the research protocol,
- Patients with a history of prior abdominal surgery,
- Patients who were unable to understand and perform the tests properly
- Patients who refused to sign the Informed Consent Term.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery: Respiratory Muscle Strength, Lung Volumes and Diaphragmatic Excursion
OBJECTIVE: to determine whether preoperative inspiratory muscle training (IMT) is able to attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.
Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate the negative effects of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients undergoing open bariatric surgery.
Read more
DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil. SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly assigned to receive preoperative inspiratory muscle training (IMT group) or usual care (control group).
MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal expiratory pressure - MEP), lung volumes and diaphragmatic excursion.
- Conditions
- Preoperative Inspiratory Muscular Training, Bariatric Surgery, Chest Physiotherapy, Postoperative Pulmonary Complications, Obesity
- Being tested
- Inspiratory muscular training - IMT
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscular training - IMTOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Inspiratory Muscular TrainingStudies 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 Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Meridional Hospital, Conselho Nacional de Desenvolvimento Científico e Tecnológico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321983
- Sponsor's protocol ID
- 141299/2009-6
- Status last verified
- Mar 2011
- First submitted
- 23 Mar 2011
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Inspiratory Muscle Training (IMT) in Obese Women Undergoing Open Bariatric Surgery: Respiratory Muscle Strength, Lung Volumes and Diaphragmatic Excursion
- ClinicalTrials.gov ID
- NCT01321983
- Acronym / sponsor ID
- 141299/2009-6
- Conditions
- Preoperative Inspiratory Muscular Training, Bariatric Surgery, Chest Physiotherapy, Postoperative Pulmonary Complications, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Meridional Hospital, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- First posted
- 24 Mar 2011 (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 determine whether preoperative inspiratory muscle training (IMT) is able to attenuate the impact of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion in obese women undergoing open bariatric surgery.
Therefore, the hypothesis of the present study was that preoperative IMT is able to attenuate the negative effects of surgical trauma on the respiratory muscle strength, in the lung volumes and diaphragmatic excursion, thus reducing the risk of PPC, in obese patients undergoing open bariatric surgery.
DESIGN: Randomized controlled trial. SETTING: Meridional Hospital, Cariacica/ES, Brazil. SUBJECTS: Thirty-two obese women undergoing elective open bariatric surgery were randomly assigned to receive preoperative inspiratory muscle training (IMT group) or usual care (control group).
MAIN MEASURES: Respiratory muscle strength (maximal inspiratory pressure - MIP and maximal expiratory pressure - MEP), lung volumes and diaphragmatic excursion.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female,
- Over 18 years of age,
- No smoking or respiratory disease.
Key exclusion criteria (4 listed)
- Patients who refused to participate in the steps of the research protocol,
- Patients with a history of prior abdominal surgery,
- Patients who were unable to understand and perform the tests properly
- Patients who refused to sign the Informed Consent 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 |
|---|---|---|
| Inspiratory muscular training - IMT | Other | – |
Primary outcome
Not reported in the source record.
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 24 Mar 2011.
- Related InfoLink provided by the sponsor.
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 Inspiratory muscular training - IMT in people with Preoperative Inspiratory Muscular Training and Bariatric Surgery, run by Universidade Federal de Sao Carlos 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 4 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 24 Mar 2011. 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.
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 24 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.