Intensive Care Unit SyndromeNCT06251791
Inspiratory Muscle Training and Expiratory Muscle Thickness
A study testing conventional physiotherapy+ IMT and conventional physiotherapy in people with Intensive Care Unit Syndrome and Muscle Weakness, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial summary
the specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in… 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 Syndrome, Muscle Weakness, Rehabilitation
- What is being tested?
- conventional physiotherapy+ IMT and conventional physiotherapy
- 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 1 Nov 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Body Mass Index <40 m2/cm,
- FiO2 of 0.5 or less,
- Absence of myocardial ischemia.
Who cannot join
- 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.
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- 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: Exploring The Impact Of Inspiratory Muscle Training on Expiratory Muscle Thickness During Intensive Care Patients
the specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in respiratory ICU patients. On the other hand the investigators established reference values for ultrasonographic measurements in healthy control subjects as a comparative arm. To the best of our knowledge, this is the first study to examine the ultrasonographic effects of IMT on the expiratory muscle thickness after extubation. The investigators believe that our study may contribute to related literature in this context and guide future research as a pioneer with its unique value.
Read the detailed description
the specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in respiratory ICU patients. On the other hand the investigators established reference values for ultrasonographic measurements in healthy control subjects as a comparative arm. To the best of our knowledge, this is the first study to examine the ultrasonographic effects of IMT on the expiratory muscle thickness after extubation. The investigators believe that our study may contribute to related literature in this context and guide future research as a pioneer with its unique value. In this single-blind randomized controlled study, 20 patients were divided into two groups: IMT and conventional physiotherapy(CP). In order to establish normative data for abdominal muscle thickness, ten healthy controls were included in the study. The CP group received CP and the IMT group received CP+IMT for five days following extubation. The thicknesses of the external oblique abdominal(EOA),internal oblique sbdominal(IOA), transversus abdominus (TRA) and rectus abdominis (RA) muscleswere evaluated The maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were recorded.
- Being tested
- conventional physiotherapy+ IMT, conventional physiotherapy
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapy+ IMTOther
Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. 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.
conventional physiotherapyOther
Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental: Conventional Physiotherapy In the intensive care unit and who had mechanical ventilation for more than 48 hours and who were extubated. 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. Receives: Other: conventional physiotherapy+ IMT |
| Conventional | Experimental | 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 |
| Healthy controls | No intervention | There is no intervention in this group. Baseline measurements are to compare with experimental groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Muscle Thickness
Eksternal Oblique, Internal Oblique, Transverses Abdominus and rectus abdominus Ultrasonografic mesasurements
Measured: Change from baseline Maximal inspiratory and expiratory pressure at 5th day]
Secondary outcomes (1)
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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Sep 2021
- Primary completion1 Dec 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies 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 Parallel Assignment Randomized Healthy participants
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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, MD, Study chair, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251791
- Sponsor's protocol ID
- IMT on abdominal muscle
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring The Impact Of Inspiratory Muscle Training on Expiratory Muscle Thickness During Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06251791
- Acronym / sponsor ID
- IMT on abdominal muscle
- 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
- 1 Dec 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 9 Feb 2024 (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 specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in respiratory ICU patients. On the other hand the investigators established reference values for ultrasonographic measurements in healthy control subjects as a comparative arm. To the best of our knowledge, this is the first study to examine the ultrasonographic effects of IMT on the expiratory muscle thickness after extubation. The investigators believe that our study may contribute to related literature in this context and guide future research as a pioneer with its unique value.
Detailed description
the specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in respiratory ICU patients. On the other hand the investigators established reference values for ultrasonographic measurements in healthy control subjects as a comparative arm. To the best of our knowledge, this is the first study to examine the ultrasonographic effects of IMT on the expiratory muscle thickness after extubation. The investigators believe that our study may contribute to related literature in this context and guide future research as a pioneer with its unique value. In this single-blind randomized controlled study, 20 patients were divided into two groups: IMT and conventional physiotherapy(CP). In order to establish normative data for abdominal muscle thickness, ten healthy controls were included in the study. The CP group received CP and the IMT group received CP+IMT for five days following extubation. The thicknesses of the external oblique abdominal(EOA),internal oblique sbdominal(IOA), transversus abdominus (TRA) and rectus abdominis (RA) muscleswere evaluated The maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Parallel Assignment Parallel Assignment Randomized Healthy participants
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: conventional physiotherapy+ IMTExperimental: Conventional Physiotherapy In the intensive care unit and who had mechanical ventilation for more than 48 hours and who were extubated. 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. |
| Conventional | Experimental | Other: conventional physiotherapyIn 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. |
| Healthy controls | No intervention | –There is no intervention in this group. Baseline measurements are to compare with experimental groups. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For Patients Group Inclusion Criteria:
Key exclusion criteria (14 listed)
- For Patients Group Exclusion 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
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 physiotherapy+ IMTConventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. 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. | Other | Experimental |
| conventional physiotherapyConventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. | Other | Conventional |
Primary outcome
Abdominal Muscle Thickness
Time frame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day]
Eksternal Oblique, Internal Oblique, Transverses Abdominus and rectus abdominus Ultrasonografic mesasurements
1 secondary outcome
Maximal inspiratory and expiratory pressure
Time frame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day]
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 13 Feb 2024.
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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, MD 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+ IMT and conventional physiotherapy in people with Intensive Care Unit Syndrome and Muscle 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?
The sponsor lists 9 inclusion and 14 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 13 Feb 2024. 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?
Abdominal Muscle Thickness (time frame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day]). 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 13 Feb 2024.