Intensive Care Unit Acquired WeaknessNCT05303623
The Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients
A study testing Conventional Physiotherapy, Conventional Physiotherapy+ inspiratory muscle training and inspiratory muscle training in people with Intensive Care Unit Acquired Weakness, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of inspiratory muscle training on diaphragmatic functions will be investigated radiologically in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit Acquired Weakness
- What is being tested?
- Conventional Physiotherapy, Conventional Physiotherapy+ inspiratory muscle training and inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 25 Dec 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
For Patients Group Inclusion Criteria:
- Needing mechanical ventilation support longer than 2 days,
- Alert and Riker Sedation Agitation Score >4
- Being hemodynamically stable (HR<140 beats/min, BP stable)
- Dobutamine and minimal vasopressor use
- Fever of 36.5-38.5
- Body Mass Index <40 m2/cm,
- FiO2 of 0.5 or less,
- Absence of myocardial ischemia.
For Patients Group Exclusion Criteria:
- Noncooperation
- Phrenic nerve damage
- Chest wall trauma and/or deformity to prevent diaphragmatic movement
- Progressive neuromuscular disease with respiratory involvement
- There is enough secretion to require more than one aspiration every hour.
- Patients using sedative drugs continuously
- High-dose cortisol use
- Using a home mechanical ventilator before mechanical ventilation in intensive care unit
For Healthy Group Inclusion Criteria:
- With the control and intervention group, age, characteristics and characteristics,
- Chronic system and no ongoing treatment,
- Body mass index not 40 kg/m2,
- 18-80 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiological and Cardiopulmonary Evaluation of the Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients in the Intensive Care Unit
In this study, the effect of inspiratory muscle training on diaphragmatic functions will be investigated radiologically in mechanically ventilated patients.
Read the detailed description
Many patients who receive treatment in intensive care need mechanical ventilation support. Invasive mechanical ventilation is an application used in critically ill patients to provide pulmonary gas exchange and to relieve the respiratory muscles. Mechanical ventilation and long- term bed rest induced extremity muscle weakness is a common condition in patients hospitalized in the intensive care unit. Acquired muscle weakness in intensive care is associated with poor prognosis and high mortality At the same time, mechanical ventilation can lead to the development of respiratory muscle dystrophy and atrophy.
Recently, a similar concern has arisen about the potential negative effects of mechanical ventilation on respiratory muscles. This condition is called ventilator-induced diaphragmatic dysfunction In patients with mechanical ventilation, dysfunction, muscle fiber type change and barotrauma are seen especially in the diaphragm, which is the primary inspiratory muscle. Diaphragmatic dysfunction may promote prolong of intubation, weaning difficulties and risk of increase reintubation in patients who are mechanically ventilated.
The effect of inspiratory muscle training, which is applied in addition to conventional respiratory physiotherapy, on diaphragmatic dysfunction, on the weaning process and the long of stay in intensive care has not been fully elucidated, and a limited number of studies have been conducted on this subject It has been reported that in patients with prolonged mechanical ventilation, diaphragmatic peak contraction velocity, peak relaxation velocity, movement speed, velocity time integral are lower than healthy individuals and this is correlated with failure to wean from mechanical ventilation. We could not find any report and clinical trial in the literature evaluation the effect of conventional physiotherapy and additional inspiratory muscle training on diaphragmatic tissue movement velocity and diaphragm thickness using detailed radiological methods in intensive care patients dependent on mechanical ventilation. In this context, our not working has a unique value. Our study will contribute to elucidating the mechanisms that affect the weaning process from mechanical ventilation in intensive care patients. It is aimed to develop strategies that will shorten the long of stay in intensive care and total hospital stay with therapeutic approaches that enable patients to be extubated as early as possible.
- Conditions
- Intensive Care Unit Acquired Weakness
- Being tested
- Conventional Physiotherapy, Conventional Physiotherapy+ inspiratory muscle training, inspiratory muscle training
- Keywords
- mechanical ventilated patients, Inspiratory muscle training, Physiotherapy and rehabilitation, diaphragmatic issue doppler, Respiratory muscle thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day.
Conventional Physiotherapy+ inspiratory muscle trainingOther
Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. In this group addition to conventional physiotherapy inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.
inspiratory muscle trainingOther
In this group inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy | Experimental | In the intensive care unit and who had mechanical ventilation for more than 48 hours and who were extubated. Medical, physical and respiratory examination in this group Physical Function Test in Intensive Care (PFIT), maximum inspiratory mouth pressure and maximum expiratory mouth pressure, Medical Research Council Muscle Strength Test and diaphragmatic function with B mode and M mode ultrasonographic assessment.
In this group will apply only conventional physiotherapy. Conventional physiotherapy to contain breathing and,thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization. Conventional physiotherapy apply for 5 days after extubation period 1 time a day. Receives: Other: Conventional Physiotherapy |
| Conventional Physiotherapy + inspiratory muscle training | Experimental | Physical ,medical and respiratory examination in this group Physical Function Test in Intensive Care (PFIT), maximum inspiratory mouth pressure and maximum expiratory mouth pressure, Medical Research Council Muscle Strength Test and diaphragmatic function with B mode and M mode ultrasonographic assessment. In this group, inspiratory muscle training will be applied in addition to conventional physiotherapy.
Inspiratory muscle training apply for 5 days after extubation period. Inspiratory muscle training will be given with a threshold loading by giving resistance at 30-40% of the maximum inspiratory pressure measurement obtained. The subjects in this group will be given inspiratory muscle training 4 sets with 6-10 breaths per set, 1-2 minutes between each set once a day in addition to conventional physiotherapy. Receives: Other: Conventional Physiotherapy+ inspiratory muscle training |
| Healthy Subject | Experimental | In the group consisting of healthy volunteers, which will be taken to determine the normative values of the outcome measurements for diaphragmatic tissue Doppler imaging and ultrasonographic evaluation, 2 sessions a day with a threshold-loaded inspiratory muscle training device, starting at 30% of the MIP value, 5 days a week for 4 weeks. Inspiratory muscle training will be performed in 4 sets, 6-8 breaths in each set and 2 minutes rest between sets. In the second evaluation to be made after the inspiratory muscle training, the above-mentioned evaluations and measurements will be repeated. Receives: Other: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory and expiratory pressure
Intraoral pressures measured at maximal respiration against a valve that closes the airway during maximal inspiration pressure and expiration. Maximal inspiration pressure is the highest pressure created to open closed alveoli at the residual volume level. In our study, respiratory muscle strength will be performed using a portable, electronic mouth pressure measuring with device. For the test, the applied person is given maximum expiration and at the end of this, the airway is closed with a valve and the person is asked to make maximum inspiration and continue it for 1-3 seconds. In the maximal expiration pressure measurement, after maximal inspiration, the person is asked to make a maximal expiration for 1-3 seconds against the closed airway. The best of the three measurements is selected. There should be no more than 10% or more than 10 cmH2O difference between the two best measured
Measured: Change from baseline Maximal inspiratory and expiratory pressure at 5th day
Diaphragmatic B mode, M mode and Tissue Doppler Ultrasonographic Imagining
Doppler Ultrasound evaluation to evaluate the diaphragmatic tissue waveform will be performed with an ultrasound probe placed in the right hemidiaphragm. Tissue movement rates will be evaluated during inspiration and expiration. The maximum contraction and relaxation rate of the diaphragm will be recorded with the sonographic evaluation to be made during 10 normal breaths. In addition, while sitting upright with a 90 degree angle in two-dimensional B mode, diaphragm thickness will be measured from the right intercostal area from the midaxillary level, from the right subcostal area from the anterior axillary level and mid-clavicular level with the superficial probe during deep inspiration and deep expiration. Diaphragm mobility in normal inspiration and deep inspiration from the mid-axillary level from the right subcostal area with M-mode ultrasonography will be evaluated by a pulmonologist before and after the training.
Measured: Change from baseline diaphragmatic evaluation at 5th day
Respiratory Muscle Thickness
With B mode ultrasound, the thickness of the internal oblique abdominis, external oblique abdominis and transversus abdominis muscles is measured 2-3 fingers above the umbilicus.
Measured: Change from baseline Respiratory Muscle Ultrasonographic Imagining evaluation at 5th day
Physical Function Test (PFIT) battery
The physical function levels of the cases in the intensive care unit will be evaluated with the Physical Function Test (PFIT) battery in the intensive care unit. PFIT is a test battery applied by the researcher, consisting of 4 main headings: Support (Stand up without sitting)', 'Cadence (steps/minute)', 'Shoulder (flexion strength)' and 'Knee (extension strength)'. are scored according to the degree of assistance (0-unassisted, 1-with the help of one person, 2-with the help of two people). Standing will be recorded as the number of steps and time performed in standing-stand action. Shoulder and knee muscle strength manual muscle test (0-unable , 1- there is only contraction, 2- completes the movement when gravity is eliminated, 3- completes the movement against gravity, 4- completes the movement with less than maximum resistance to gravity, 5- completes the movement with maximum resistance against gravity).
Measured: Change from baseline Physical Function Test (PFIT) battery 5th day
Medical Research Council(MRC) Strength Test
Six muscle groups (abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the hip, extension of the knee, and dorsal flexion of the foot) bilaterally. The tests were performed in the ICU. All muscle groups were scored between 0 and 5 (0 = no visible/palpable contraction; 1 = visible/palpable contraction without movement of the limb; 2 = movement of the limb but not against gravity; 3 = movement against gravity (almost full passive range of motion) but not against resistance; 4 = movement against gravity and resistance, arbitrarily judged to be submaximal for gender and age; 5 = normal).
Measured: Change from baseline Medical Research Council(MRC) Strength Test battery 5th day
Acute Care Index of Function (ACIF)
Sub-components of the ACIF include 'Mental Status,' 'Bed Mobility,' 'Transfers' and 'Mobility.'20 total item instrument with activities to measure cognition and functional mobility.
Measured: Change from baseline Acute Care Index of Function (ACIF) 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Sep 2021
- Primary completion15 Sep 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Acquired WeaknessStudies 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
- Parallel Assignment Randomized Healthy participants
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Kaygusuz, Istanbul Demiroglu Bilim University
- Investigators
- Barış Yılmaz, Specialist, Study chair, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303623
- Sponsor's protocol ID
- doctoral thesis
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Cardiopulmonary Evaluation of the Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05303623
- Acronym / sponsor ID
- doctoral thesis
- Conditions
- Intensive Care Unit Acquired Weakness
- Keywords
- mechanical ventilated patients, Inspiratory muscle training, Physiotherapy and rehabilitation, diaphragmatic issue doppler, Respiratory muscle thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 31 Mar 2022 (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.
In this study, the effect of inspiratory muscle training on diaphragmatic functions will be investigated radiologically in mechanically ventilated patients.
Detailed description
Many patients who receive treatment in intensive care need mechanical ventilation support. Invasive mechanical ventilation is an application used in critically ill patients to provide pulmonary gas exchange and to relieve the respiratory muscles. Mechanical ventilation and long- term bed rest induced extremity muscle weakness is a common condition in patients hospitalized in the intensive care unit. Acquired muscle weakness in intensive care is associated with poor prognosis and high mortality At the same time, mechanical ventilation can lead to the development of respiratory muscle dystrophy and atrophy.
Recently, a similar concern has arisen about the potential negative effects of mechanical ventilation on respiratory muscles. This condition is called ventilator-induced diaphragmatic dysfunction In patients with mechanical ventilation, dysfunction, muscle fiber type change and barotrauma are seen especially in the diaphragm, which is the primary inspiratory muscle. Diaphragmatic dysfunction may promote prolong of intubation, weaning difficulties and risk of increase reintubation in patients who are mechanically ventilated.
The effect of inspiratory muscle training, which is applied in addition to conventional respiratory physiotherapy, on diaphragmatic dysfunction, on the weaning process and the long of stay in intensive care has not been fully elucidated, and a limited number of studies have been conducted on this subject It has been reported that in patients with prolonged mechanical ventilation, diaphragmatic peak contraction velocity, peak relaxation velocity, movement speed, velocity time integral are lower than healthy individuals and this is correlated with failure to wean from mechanical ventilation. We could not find any report and clinical trial in the literature evaluation the effect of conventional physiotherapy and additional inspiratory muscle training on diaphragmatic tissue movement velocity and diaphragm thickness using detailed radiological methods in intensive care patients dependent on mechanical ventilation. In this context, our not working has a unique value. Our study will contribute to elucidating the mechanisms that affect the weaning process from mechanical ventilation in intensive care patients. It is aimed to develop strategies that will shorten the long of stay in intensive care and total hospital stay with therapeutic approaches that enable patients to be extubated as early as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment Randomized Healthy participants
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | Experimental | Other: Conventional PhysiotherapyIn the intensive care unit and who had mechanical ventilation for more than 48 hours and who were extubated. Medical, physical and respiratory examination in this group Physical Function Test in Intensive Care (PFIT), maximum inspiratory mouth pressure and maximum expiratory mouth pressure, Medical Research Council Muscle Strength Test and diaphragmatic function with B mode and M mode ultrasonographic assessment. In this group will apply only conventional physiotherapy. Conventional physiotherapy to contain breathing and,thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization. Conventional physiotherapy apply for 5 days after extubation period 1 time a day. |
| Conventional Physiotherapy + inspiratory muscle training | Experimental | Other: Conventional Physiotherapy+ inspiratory muscle trainingPhysical ,medical and respiratory examination in this group Physical Function Test in Intensive Care (PFIT), maximum inspiratory mouth pressure and maximum expiratory mouth pressure, Medical Research Council Muscle Strength Test and diaphragmatic function with B mode and M mode ultrasonographic assessment. In this group, inspiratory muscle training will be applied in addition to conventional physiotherapy. Inspiratory muscle training apply for 5 days after extubation period. Inspiratory muscle training will be given with a threshold loading by giving resistance at 30-40% of the maximum inspiratory pressure measurement obtained. The subjects in this group will be given inspiratory muscle training 4 sets with 6-10 breaths per set, 1-2 minutes between each set once a day in addition to conventional physiotherapy. |
| Healthy Subject | Experimental | Other: inspiratory muscle trainingIn the group consisting of healthy volunteers, which will be taken to determine the normative values of the outcome measurements for diaphragmatic tissue Doppler imaging and ultrasonographic evaluation, 2 sessions a day with a threshold-loaded inspiratory muscle training device, starting at 30% of the MIP value, 5 days a week for 4 weeks. Inspiratory muscle training will be performed in 4 sets, 6-8 breaths in each set and 2 minutes rest between sets. In the second evaluation to be made after the inspiratory muscle training, the above-mentioned evaluations and measurements will be repeated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Conventional PhysiotherapyConventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. | Other | Conventional Physiotherapy |
| Conventional Physiotherapy+ inspiratory muscle trainingConventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. In this group addition to conventional physiotherapy inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets. | Other | Conventional Physiotherapy + inspiratory muscle training |
| inspiratory muscle trainingIn this group inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets. | Other | Healthy Subject |
Primary outcome
Maximal inspiratory and expiratory pressure
Time frame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day
Intraoral pressures measured at maximal respiration against a valve that closes the airway during maximal inspiration pressure and expiration. Maximal inspiration pressure is the highest pressure created to open closed alveoli at the residual volume level. In our study, respiratory muscle strength will be performed using a portable, electronic mouth pressure measuring with device. For the test, the applied person is given maximum expiration and at the end of this, the airway is closed with a valve and the person is asked to make maximum inspiration and continue it for 1-3 seconds. In the maximal expiration pressure measurement, after maximal inspiration, the person is asked to make a maximal expiration for 1-3 seconds against the closed airway. The best of the three measurements is selected. There should be no more than 10% or more than 10 cmH2O difference between the two best measured
Diaphragmatic B mode, M mode and Tissue Doppler Ultrasonographic Imagining
Time frame: Change from baseline diaphragmatic evaluation at 5th day
Doppler Ultrasound evaluation to evaluate the diaphragmatic tissue waveform will be performed with an ultrasound probe placed in the right hemidiaphragm. Tissue movement rates will be evaluated during inspiration and expiration. The maximum contraction and relaxation rate of the diaphragm will be recorded with the sonographic evaluation to be made during 10 normal breaths. In addition, while sitting upright with a 90 degree angle in two-dimensional B mode, diaphragm thickness will be measured from the right intercostal area from the midaxillary level, from the right subcostal area from the anterior axillary level and mid-clavicular level with the superficial probe during deep inspiration and deep expiration. Diaphragm mobility in normal inspiration and deep inspiration from the mid-axillary level from the right subcostal area with M-mode ultrasonography will be evaluated by a pulmonologist before and after the training.
Respiratory Muscle Thickness
Time frame: Change from baseline Respiratory Muscle Ultrasonographic Imagining evaluation at 5th day
With B mode ultrasound, the thickness of the internal oblique abdominis, external oblique abdominis and transversus abdominis muscles is measured 2-3 fingers above the umbilicus.
Physical Function Test (PFIT) battery
Time frame: Change from baseline Physical Function Test (PFIT) battery 5th day
The physical function levels of the cases in the intensive care unit will be evaluated with the Physical Function Test (PFIT) battery in the intensive care unit. PFIT is a test battery applied by the researcher, consisting of 4 main headings: Support (Stand up without sitting)', 'Cadence (steps/minute)', 'Shoulder (flexion strength)' and 'Knee (extension strength)'. are scored according to the degree of assistance (0-unassisted, 1-with the help of one person, 2-with the help of two people). Standing will be recorded as the number of steps and time performed in standing-stand action. Shoulder and knee muscle strength manual muscle test (0-unable , 1- there is only contraction, 2- completes the movement when gravity is eliminated, 3- completes the movement against gravity, 4- completes the movement with less than maximum resistance to gravity, 5- completes the movement with maximum resistance against gravity).
Medical Research Council(MRC) Strength Test
Time frame: Change from baseline Medical Research Council(MRC) Strength Test battery 5th day
Six muscle groups (abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the hip, extension of the knee, and dorsal flexion of the foot) bilaterally. The tests were performed in the ICU. All muscle groups were scored between 0 and 5 (0 = no visible/palpable contraction; 1 = visible/palpable contraction without movement of the limb; 2 = movement of the limb but not against gravity; 3 = movement against gravity (almost full passive range of motion) but not against resistance; 4 = movement against gravity and resistance, arbitrarily judged to be submaximal for gender and age; 5 = normal).
Acute Care Index of Function (ACIF)
Time frame: Change from baseline Acute Care Index of Function (ACIF) 5th day
Sub-components of the ACIF include 'Mental Status,' 'Bed Mobility,' 'Transfers' and 'Mobility.'20 total item instrument with activities to measure cognition and functional mobility.
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 2 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Barış Yılmaz, Specialist study chair
Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy, Conventional Physiotherapy+ inspiratory muscle training and inspiratory muscle training in people with Intensive Care Unit Acquired Weakness, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Mar 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 Turkey (Türkiye). 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?
Maximal inspiratory and expiratory pressure (time frame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day). The study lists 6 primary outcomes in all. 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 2 Mar 2023.