ObesityPhase 1NCT01084447
Inspiratory Muscle Training After Gastroplasty
A Phase 1 study testing inspiratory muscle training in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 58 years
- Conditions the study is for
- Obesity
- What is being tested?
- inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2004to Aug 2005
- Phase
- Phase 1
- 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 20 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- gastroplasty patients presenting body mass index (BMI) ≥ 35 kg/m2;
- weighting ≤ 60 kg/m2;
- capable of fulfilling the experimental protocol.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Medicine of Ribeirão Preto, University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- inspiratory muscle training, control group
- Keywords
- obesity, gastroplasty, respiratory muscle training, muscle strength, physical therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingDevice
Also called respiratory 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.
control groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | In placebo muscular training group the respiratory exercise was used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA) no load. Receives: Device: control group |
| trained group | Active comparator | 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. Receives: Device: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum static respiratory pressures
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.
Measured: post-operative days 2, 7, 14, and 30
Inspiratory muscular endurance test
This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position.
Measured: post-operative days 2, 7, 14, and 30.
Spirometric measurements
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).
Measured: post-operative days 2, 7, 14, and 30.
Secondary outcomes (3)
Maximum static respiratory pressures
Measured: post-operative days 2, 7, 14, and 30
Inspiratory muscular endurance test
Measured: post-operative days 2, 7, 14, and 30
Spirometric measurements
Measured: post-operative days 2, 7, 14, and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2004
- Primary completionAug 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Ada C Gastaldi, PHD, Principal investigator, Faculty of Medicine of Ribeirao Preto-University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084447
- Sponsor's protocol ID
- USP-2010
- Status last verified
- Mar 2010
- First submitted
- 4 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christensen EF, Schultz P, Jensen OV, Egebo K, Engberg M, Gron I, Juhl B. Postoperative pulmonary complications and lung function in high-risk patients: a comparison of three physiotherapy regimens after upper abdominal surgery in general anesthesia. Acta Anaesthesiol Scand. 1991 Feb;35(2):97-104. doi: 10.1111/j.1399-6576.1991.tb03255.x.
PubMed 2024569Dronkers J, Veldman A, Hoberg E, van der Waal C, van Meeteren N. Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study. Clin Rehabil. 2008 Feb;22(2):134-42. doi: 10.1177/0269215507081574. Epub 2007 Dec 5.
PubMed 18057088Casali CC, Pereira AP, Martinez JA, de Souza HC, Gastaldi AC. Effects of inspiratory muscle training on muscular and pulmonary function after bariatric surgery in obese patients. Obes Surg. 2011 Sep;21(9):1389-94. doi: 10.1007/s11695-010-0349-y.
PubMed 21229331
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients
- ClinicalTrials.gov ID
- NCT01084447
- Acronym / sponsor ID
- USP-2010
- Conditions
- Obesity
- Keywords
- obesity, gastroplasty, respiratory muscle training, muscle strength, physical therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 10 Mar 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Device: control groupIn placebo muscular training group the respiratory exercise was used a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA) no load. |
| trained group | Active comparator | Device: inspiratory muscle trainingIn 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. |
Who may qualify
- Ages
- 20 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- gastroplasty patients presenting body mass index (BMI) ≥ 35 kg/m2;
- weighting ≤ 60 kg/m2;
- capable of fulfilling the experimental protocol.
Key exclusion criteria (5 listed)
- 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.
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 muscle trainingAlso: respiratory trainingThis 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. | Device | trained group |
| control groupIn 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. | Device | control group |
Primary outcome
Maximum static respiratory pressures
Time frame: post-operative days 2, 7, 14, and 30
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.
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.
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).
3 secondary outcomes
Maximum static respiratory pressures
Time frame: post-operative days 2, 7, 14, and 30
Inspiratory muscular endurance test
Time frame: post-operative days 2, 7, 14, and 30
Spirometric measurements
Time frame: post-operative days 2, 7, 14, and 30.
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 10 Mar 2010.
- Background: PubMed 2024569Christensen EF, Schultz P, Jensen OV, Egebo K, Engberg M, Gron I, Juhl B. Postoperative pulmonary complications and lung function in high-risk patients: a comparison of three physiotherapy regimens after upper abdominal surgery in general anesthesia. Acta Anaesthesiol Scand. 1991 Feb;35(2):97-104. doi: 10.1111/j.1399-6576.1991.tb03255.x.
- Background: PubMed 18057088Dronkers J, Veldman A, Hoberg E, van der Waal C, van Meeteren N. Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study. Clin Rehabil. 2008 Feb;22(2):134-42. doi: 10.1177/0269215507081574. Epub 2007 Dec 5.
- Derived from this study: PubMed 21229331Casali CC, Pereira AP, Martinez JA, de Souza HC, Gastaldi AC. Effects of inspiratory muscle training on muscular and pulmonary function after bariatric surgery in obese patients. Obes Surg. 2011 Sep;21(9):1389-94. doi: 10.1007/s11695-010-0349-y.
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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.
Ada C Gastaldi, PHD principal investigator
Faculty of Medicine of Ribeirao Preto-University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing inspiratory muscle training in people with Obesity, run by University of Sao Paulo 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 5 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 10 Mar 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximum static respiratory pressures (time frame: post-operative days 2, 7, 14, and 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084447, which also lists 3 linked publications.
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 10 Mar 2010.