UndernutritionNCT02200198
Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery
A study testing Expiratory muscle training and Inspiratory muscle training in people with Undernutrition and Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undernutrition, Surgery
- What is being tested?
- Expiratory muscle training and Inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized malnourished patients (BMI ≤ 20 Kg/m2, loss of body weight ≥ 10% unintentional, or serum albumin <3.5 g/dL)
- candidate to elective abdominal surgery
- ability to perform all evaluations and training
Who cannot join
- previous respiratory disease
- necessity of over than 48h of mechanical ventilation
- reoperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery
Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. How the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.
- Conditions
- Undernutrition, Surgery
- Being tested
- Expiratory muscle training, Inspiratory muscle training, Sham group
- Keywords
- undernutrition, abdominal surgery, respiratory muscles, muscles strength, pulmonary complication, perioperative care
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory muscle trainingOther
Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor
Inspiratory muscle trainingOther
Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor
Sham groupOther
Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory group | Active comparator | Inspiratory muscle training Receives: Other: Inspiratory muscle training |
| Sham group | Sham comparator | Sham training Receives: Other: Sham group |
| Expiratory group | Experimental | Expiratory muscle training Receives: Other: Expiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory peak flow in spirometry
Assessed as expiratory peak flow in spirometry
Measured: on the 8th day of protocol (after 7 dyas of training)
Secondary outcomes (2)
Maximum respiratory pressures
Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure
Measured: on the 8th day of protocol (after 7 days of training)
Postoperative pulmonary complication
The following pulmonary complications were considered: atelectasis with clinical consequences, hypoxemia with oxygen saturation <85%, and need for supplemental oxygen, pneumonia and acute respiratory failure.
The diagnosis of complication was performed by a physician who was blinded to the intervention group.
Measured: participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startFeb 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celso RF Carvalho, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200198
- Sponsor's protocol ID
- 0613/07
- Status last verified
- Jul 2014
- First submitted
- 23 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02200198
- Acronym / sponsor ID
- 0613/07
- Conditions
- Undernutrition, Surgery
- Keywords
- undernutrition, abdominal surgery, respiratory muscles, muscles strength, pulmonary complication, perioperative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jul 2014 (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.
Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. How the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory group | Active comparator | Other: Inspiratory muscle trainingInspiratory muscle training |
| Sham group | Sham comparator | Other: Sham groupSham training |
| Expiratory group | Experimental | Other: Expiratory muscle trainingExpiratory muscle training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hospitalized malnourished patients (BMI ≤ 20 Kg/m2, loss of body weight ≥ 10% unintentional, or serum albumin <3.5 g/dL)
- candidate to elective abdominal surgery
- ability to perform all evaluations and training
Key exclusion criteria (3 listed)
- previous respiratory disease
- necessity of over than 48h of mechanical ventilation
- reoperation
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 |
|---|---|---|
| Expiratory muscle trainingPatient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor | Other | Expiratory group |
| Inspiratory muscle trainingPatient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor | Other | Inspiratory group |
| Sham groupPatient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load | Other | Sham group |
Primary outcome
Expiratory peak flow in spirometry
Time frame: on the 8th day of protocol (after 7 dyas of training)
Assessed as expiratory peak flow in spirometry
2 secondary outcomes
Maximum respiratory pressures
Time frame: on the 8th day of protocol (after 7 days of training)
Postoperative pulmonary complication
Time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days
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 25 Jul 2014.
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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.
Celso RF Carvalho, PhD study director
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 study testing Expiratory muscle training and Inspiratory muscle training in people with Undernutrition and Surgery, run by University of Sao Paulo General Hospital 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 3 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 25 Jul 2014. 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.
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?
Expiratory peak flow in spirometry (time frame: on the 8th day of protocol (after 7 dyas of training)). 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 25 Jul 2014.