Respiratory InsufficiencyIMTversusMVNCT03758573
Effectiveness Inspirational Muscle Training
A study testing Inspiratory Muscle Training (IMT) and Intensive Physiotherapy (IPT) in people with Respiratory Insufficiency, run by Universidade Federal do vale do São Francisco at 1 site in Brazil.
Trial summary
The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Inspiratory Muscle Training (IMT) and Intensive Physiotherapy (IPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2019to 31 Dec 2023
- 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
- invasive mechanical ventilation
- patients hemodynamically stable
- without use of vasoactive drugs
Who cannot join
- spindle trauma
- neuromuscular diseases
- end-stage disease
- pneumothorax
- rib fracture
- diaphragmatic injury
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- postoperative pulmonary surgeries
- abdominal disease
- morbidities that have repercussions on diaphragmatic contraction
- mechanical ventilation with FiO2 > 60% and PEEP > 10 cm H2O
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Physical Education College
Petrolina, Pernambuco, 56304917
Rodrigo GS Carvalho, PhD, 8721016856, rodrigo.carvalho@univasf.edu.br
Rodrigo GS Carvalho, PhD, 8721016856, rodrigocarvalhofisio@gmail.com
About this study
Official title: Effectiveness of Early Inspirational Muscle Training in Patients Submitted to Mechanical Ventilation: a Randomized Clinical Trial
The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
Read the detailed description
The study will consist of a randomized controlled clinical trial conducted at the Intensive Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes, aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free and Informed Consent Form, signed by the responsible family member. Subjects will be randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP) and peak expiratory flow pressures will be evaluated. The training group will perform respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic contraction and end-stage disease will be used as exclusion criteria. The sample data will be analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5% (p <0.05).
- Conditions
- Respiratory Insufficiency
- Being tested
- Inspiratory Muscle Training (IMT), Intensive Physiotherapy (IPT)
- Keywords
- Breathing Exercises, Respiratory Muscles, Respiration Artificial, Weaning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT)Other
Inspiratory Muscle Training (IMT)
Intensive Physiotherapy (IPT)Other
Intensive Physiotherapy (IPT)
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT. Receives: Other: Inspiratory Muscle Training (IMT) |
| Intensive Physiotherapy (IPT) | Active comparator | IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy. Receives: Other: Intensive Physiotherapy (IPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning mechanical ventilation
time of mechanical ventilation
Measured: through study completion, an average of 15 days
Secondary outcomes (3)
length of stay in the ICU
reduction length of stay in the ICU
Measured: through study completion, an average of 15 days
extubation success
extubation success after 48 hours
Measured: through study completion, an average of 2 days
death
reduction in mortality (death)
Measured: yes or not death, through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start15 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do vale do São Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Gustavo da Silva Carvalho, Universidade Federal do vale do São Francisco
- Investigators
- Rodrigo GS Carvalho, PhD, Principal investigator, Physical Education College / UNIVASF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758573
- Sponsor's protocol ID
- IMT
- Acronym
- IMTversusMV
- Status last verified
- May 2023
- First submitted
- 21 Nov 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Registration ClinicalTrials; Study Protocol; Paper results.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Inspirational Muscle Training in Patients Submitted to Mechanical Ventilation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03758573
- Acronym / sponsor ID
- IMTversusMV / IMT
- Conditions
- Respiratory Insufficiency
- Keywords
- Breathing Exercises, Respiratory Muscles, Respiration Artificial, Weaning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal do vale do São FranciscoUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Nov 2018 (actual)
- 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 long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
Detailed description
The study will consist of a randomized controlled clinical trial conducted at the Intensive Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes, aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free and Informed Consent Form, signed by the responsible family member. Subjects will be randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP) and peak expiratory flow pressures will be evaluated. The training group will perform respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic contraction and end-stage disease will be used as exclusion criteria. The sample data will be analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5% (p <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Other: Inspiratory Muscle Training (IMT)IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT. |
| Intensive Physiotherapy (IPT) | Active comparator | Other: Intensive Physiotherapy (IPT)IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- invasive mechanical ventilation
- patients hemodynamically stable
- without use of vasoactive drugs
Key exclusion criteria (10 listed)
- spindle trauma
- neuromuscular diseases
- end-stage disease
- pneumothorax
- rib fracture
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 Training (IMT)Inspiratory Muscle Training (IMT) | Other | Inspiratory Muscle Training (IMT) |
| Intensive Physiotherapy (IPT)Intensive Physiotherapy (IPT) | Other | Intensive Physiotherapy (IPT) |
Primary outcome
Weaning mechanical ventilation
Time frame: through study completion, an average of 15 days
time of mechanical ventilation
3 secondary outcomes
length of stay in the ICU
Time frame: through study completion, an average of 15 days
extubation success
Time frame: through study completion, an average of 2 days
death
Time frame: yes or not death, through study completion, an average of 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No. Registration ClinicalTrials; Study Protocol; Paper results.
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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.
Rodrigo GS Carvalho, PhD principal investigator
Physical Education College / UNIVASF
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 Muscle Training (IMT) and Intensive Physiotherapy (IPT) in people with Respiratory Insufficiency, run by Universidade Federal do vale do São Francisco 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 10 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo GS Carvalho, PhD (+5587999832015, rodrigocarvalhofisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning mechanical ventilation (time frame: through study completion, an average of 15 days). 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 10 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.