Critically Ill, Subacute Adult PatientsNCT06611683
Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit
A study testing Inspiratory muscle training and Routine care in people with Critically Ill, Subacute Adult Patients and Mechanically Ventilation, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn if inspiratory muscle training facilite the liberation of mechanical ventilation. The main questions it aims to answer are: Does inspiratory muscle training facilitate weaning from mechanical ventilation and enhance muscle strength in critically ill, subacute adult patients?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Subacute Adult Patients, Mechanically Ventilation
- What is being tested?
- Inspiratory muscle training and Routine care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 31 Dec 2020
- 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
- requiring invasive mechanical ventilation for 2 days in an ICU
Who cannot join
- hemodynamic instability (heart rate 120 beats/min, unstable blood pressure, vasopressor infusion)
- inadequate oxygenation (PEEP 8 cmH2O, FiO2 50%)
- body temperature 38.5°C
- sepsis
- use of sedative infusion
- steroid administration
- home ventilator use before ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if inspiratory muscle training facilite the liberation of mechanical ventilation. The main questions it aims to answer are:
Does inspiratory muscle training facilitate weaning from mechanical ventilation and enhance muscle strength in critically ill, subacute adult patients?
The main questions it aims to answer are:
Does pulmonary rehabilitation facilitate wwaning form mechanical patients? Does the intervention improve respiratory muscle strength and respiratory patterns?
Participants received:
Inspriatory muscle training twice daily for three consecutive weeks or until the subject no longer required ventilator support.
Read the detailed description
Patients on mechanical ventilation often experience rapid diaphragm atrophy on the second day, resulting in muscle fiber changes, respiratory muscle weakness. Clinical studies have explored enhancing diaphragm and respiratory muscle strength and endurance through inspiratory muscle, expiratory muscle, and combined respiratory muscle training. This study was to determine if inspiratory muscle training significantly facilitates liberation from mechanical ventilation and improves muscle strength when compared to without IMT among subacute critically ill adult patients.
- Being tested
- Inspiratory muscle training, Routine care
- Keywords
- sub-acute critical ill, mechanical ventilation, respiratory muscle training, respiratory muscle strength, rapid shallow breathing index
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingProcedure or surgery
A threshold inspiratory muscule device used a starting resistance set at 30% maximum inspiratory pressure, connecting to subject artificial airway. The subjects were then instructed to perform fast and forceful inspirations against added inspiratory resistance. The inspiratory muscle training was conducted twice daily over five consecutive days, followed by a two-day rest period. This regimen continued for three consecutive weeks or until the subject no longer required ventilator support.
Routine careProcedure or surgery
Subjects received routine care without intervention.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Subjects received inspiratory muscle training twice daily over five consecutive days, followed by a two-day rest period. This regimen was continued for three consecutive weeks or until the subject no longer required ventilator support. Receives: Procedure: Inspiratory muscle training |
| Non-inspiratory muscle training | Sham comparator | Subjects received routine care. Receives: Procedure: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days until liberation from mechanical ventilation
A record of the number of days until liberation from mechanical ventilation.
Measured: Three weeks
Secondary outcomes (5)
Maximum inspiratory pressure
Maximum inspiratory pressure was measured by having each subject exert maximum inspiratory force against a pressure gauge.
Measured: Three weeks
Maximum expiratory pressure
Maximum expiratory pressure was measured by having each subject exert maximum expiratory force against a pressure gauge.
Measured: Three weeks
Peak expiratory flow
The peak expiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.
Measured: Three weeks
Peak inspiratory flow
The peak inspiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.
Measured: Three weeks
Rapid Shallow breathing index
The RSBI was calculated by dividing the respiratory rate by the tidal volume
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically Ill, Subacute Adult PatientsStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Zouying Armed Forces General Hospital, Kaohsiung Chang Gung Memorial Hospital,Taiwan
- Responsible party
- Principal investigator, Hui-Ling Lin, Chang Gung University
- Investigators
- Shu-Jane Wang, MS, Study director, Zouying Armed Forces General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611683
- Sponsor's protocol ID
- KAFGHIRB107-027
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data is available upon request from the principal investigator.
Publications
Wang SJ, Fang TP, Rowley DD, Liu NW, Chen JO, Liu JF, Lin HL. Inspiratory muscle training facilitates liberation from mechanical ventilation in subacute critically ill patients-a randomized controlled trial. Front Med (Lausanne). 2025 Jan 29;11:1503678. doi: 10.3389/fmed.2024.1503678. eCollection 2024.
PubMed 39944819
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06611683
- Acronym / sponsor ID
- KAFGHIRB107-027
- Keywords
- sub-acute critical ill, mechanical ventilation, respiratory muscle training, respiratory muscle strength, rapid shallow breathing index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Zouying Armed Forces General Hospital, Kaohsiung Chang Gung Memorial Hospital,Taiwan
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Sep 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 goal of this clinical trial is to learn if inspiratory muscle training facilite the liberation of mechanical ventilation. The main questions it aims to answer are:
Does inspiratory muscle training facilitate weaning from mechanical ventilation and enhance muscle strength in critically ill, subacute adult patients?
The main questions it aims to answer are:
Does pulmonary rehabilitation facilitate wwaning form mechanical patients? Does the intervention improve respiratory muscle strength and respiratory patterns?
Participants received:
Inspriatory muscle training twice daily for three consecutive weeks or until the subject no longer required ventilator support.
Detailed description
Patients on mechanical ventilation often experience rapid diaphragm atrophy on the second day, resulting in muscle fiber changes, respiratory muscle weakness. Clinical studies have explored enhancing diaphragm and respiratory muscle strength and endurance through inspiratory muscle, expiratory muscle, and combined respiratory muscle training. This study was to determine if inspiratory muscle training significantly facilitates liberation from mechanical ventilation and improves muscle strength when compared to without IMT among subacute critically ill adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Procedure: Inspiratory muscle trainingSubjects received inspiratory muscle training twice daily over five consecutive days, followed by a two-day rest period. This regimen was continued for three consecutive weeks or until the subject no longer required ventilator support. |
| Non-inspiratory muscle training | Sham comparator | Procedure: Routine careSubjects received routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- requiring invasive mechanical ventilation for 2 days in an ICU
Key exclusion criteria (7 listed)
- hemodynamic instability (heart rate 120 beats/min, unstable blood pressure, vasopressor infusion)
- inadequate oxygenation (PEEP 8 cmH2O, FiO2 50%)
- body temperature 38.5°C
- sepsis
- use of sedative infusion
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 trainingA threshold inspiratory muscule device used a starting resistance set at 30% maximum inspiratory pressure, connecting to subject artificial airway. The subjects were then instructed to perform fast and forceful inspirations against added inspiratory resistance. The inspiratory muscle training was conducted twice daily over five consecutive days, followed by a two-day rest period. This regimen continued for three consecutive weeks or until the subject no longer required ventilator support. | Procedure or surgery | Inspiratory Muscle Training |
| Routine careSubjects received routine care without intervention. | Procedure or surgery | Non-inspiratory muscle training |
Primary outcome
Number of days until liberation from mechanical ventilation
Time frame: Three weeks
A record of the number of days until liberation from mechanical ventilation.
5 secondary outcomes
Maximum inspiratory pressure
Time frame: Three weeks
Maximum expiratory pressure
Time frame: Three weeks
Peak expiratory flow
Time frame: Three weeks
Peak inspiratory flow
Time frame: Three weeks
Rapid Shallow breathing index
Time frame: Three weeks
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 3 Oct 2024.
- Derived from this study: PubMed 39944819Wang SJ, Fang TP, Rowley DD, Liu NW, Chen JO, Liu JF, Lin HL. Inspiratory muscle training facilitates liberation from mechanical ventilation in subacute critically ill patients-a randomized controlled trial. Front Med (Lausanne). 2025 Jan 29;11:1503678. doi: 10.3389/fmed.2024.1503678. eCollection 2024.
- Individual participant dataSharing planned: Yes. The data is available upon request from the principal investigator.
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.
Shu-Jane Wang, MS study director
Zouying Armed Forces General 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 Inspiratory muscle training and Routine care in people with Critically Ill, Subacute Adult Patients and Mechanically Ventilation, run by Chang Gung University at 1 site in Taiwan.
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 1 inclusion and 7 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 3 Oct 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 Taiwan. 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?
Number of days until liberation from mechanical ventilation (time frame: Three weeks). 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 NCT06611683, which also lists 1 linked publication.
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 3 Oct 2024.