Respiratory InsufficiencyNCT06912308
Effect of Physiotherapy Methods on Functional and Respiratory Outcomes in ICU Patients With Respiratory Failure
A study testing Active Physiotherapy and Passive Physiotherapy in people with Respiratory Insufficiency, run by Laura Rutkauskienė at 1 site in Lithuania.
Trial summary
The aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Active Physiotherapy and Passive Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 30 Sep 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age)
- Hospitalized in the Department of Reanimation and Intensive Therapy at LSMU Kaunas Clinics
- Diagnosis of respiratory failure (KFN) based on the following TLK-10-AM codes: J96.00, J96.01, J96.9, J96.10, J96.11, J96.19, J96.90, J96.91, J96.99
- Signed informed consent obtained from the patient or their legal representative
Who cannot join
- Conscious patients who refuse to participate in the study
- Unconscious patients whose legal representative does not consent
- Recent episode of myocardial ischemia
- Pregnancy
- Heart rate < 40 bpm or > 130 bpm
- Mean arterial pressure < 60 mmHg or > 110 mmHg
- Oxygen saturation (SpO₂) ≤ 85%
- Body temperature ≥ 38.5°C or ≤ 36.0°C
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Functional and Qualitative Indicators of Critically Ill Patients With Respiratory Failure Using Different Physiotherapy Methods
The aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. By conducting this study and developing the "Physiotherapy Protocol for Critically Ill Patients Treated in the ICU," physiotherapists worldwide could be encouraged to work using a unified and adapted method.
It is expected that the results, conclusions, and practical clinical recommendations derived from this study will be beneficial not only for rehabilitation specialists and intensivists in Lithuania but also for medical professionals working with respiratory diseases, including COVID-19 patients, at various stages of their treatment and consultation.
Implementing an appropriate physiotherapy procedure protocol is anticipated to bring economic benefits, as early physiotherapy is safe and can reduce the incidence of delirium, decrease the duration of patient sedation, shorten the number of days on mechanical ventilation, and minimize hospital stay duration. Additionally, it aims to restore or improve patients' functional and independence levels, help prevent ICU-acquired weakness, and can be easily implemented in intensive care units.
- Conditions
- Respiratory Insufficiency
- Being tested
- Active Physiotherapy, Passive Physiotherapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PhysiotherapyOther
Involves patient-driven exercises such as verticalization, sitting on the edge of the bed, and active breathing exercises.
Passive PhysiotherapyOther
Employs methods like passive movements and electrostimulation of the diaphragm, providing therapeutic benefits without requiring active patient engagement.
| Study group | Role | What they receive |
|---|---|---|
| Active Physiotherapy Intervention Arm (n=75) | Experimental | The subjects of one group will receive active physiotherapy (eg: verticalization, sitting on the edge of the bed, active breathing exercises). Receives: Other: Active Physiotherapy |
| Passive Physiotherapy Intervention Arm (n=75) | Experimental | The other group will receive passive physiotherapy methods (eg: passive movements, electrostimulation of the diaphragm). Receives: Other: Passive Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge
Pulmonary function will be assessed using spirometry. The following parameters will be measured in liters and as percentages of predicted values: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1). Measurements will be taken on Day 1 (baseline) and at ICU discharge. The mean change in FVC and FEV1 will be calculated to assess respiratory improvement.
Measured: From Day 1 of ICU admission to ICU discharge (up to 50 days)
Secondary outcomes (3)
Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay
Arterial blood gas analysis will be performed to monitor oxygenation. The following parameters will be recorded daily: arterial oxygen partial pressure (PaO₂, mmHg), inspired oxygen fraction (FiO₂), and their ratio (PaO₂/FiO₂). These values will be used to assess the progression of respiratory function and severity of respiratory failure. Mean changes from baseline to ICU discharge will be analyzed.
Measured: From Day 1 of ICU admission to ICU discharge (up to 50 days)
Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session
Heart rate (beats per minute) and arterial blood pressure (systolic and diastolic, mmHg) will be measured immediately before and after each physiotherapy session to evaluate acute cardiovascular responses. Data will be recorded daily throughout the ICU stay (up to 50 days). Mean changes will be analyzed.
Measured: Immediately before and immediately after each physiotherapy session, up to 50 days during ICU stay
Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay
Patient mobility will be evaluated using the Intensive Care Unit Mobility Scale (ICUMS), which scores mobility from 0 (passive movements only) to 10 (independent ambulation). The scale will be administered at the beginning of each physiotherapy session. Mean score progression over time will be used to assess functional mobility changes.
Measured: From Day 1 of physiotherapy to ICU discharge (up to 50 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start30 Sep 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
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 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Rutkauskienė
- Sponsor type
- University, hospital or other
- Collaborators
- Lithuanian University of Health Sciences
- Responsible party
- Sponsor-investigator, Laura Rutkauskienė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912308
- Sponsor's protocol ID
- Protocol number 1 • Version 3
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For now, we do not have enough human and financial resources to share IPD, but if our circumstances change, we are open to reconsidering this decision.
Publications
Rutkauskiene L, Kubilius R, Tamosuitis T. Early mobilization, breathing exercises and chest wall oscillation in patients with bilateral pneumonia disease in the intensive care unit: a randomized clinical trial. BMC Pulm Med. 2025 Nov 25;26(1):20. doi: 10.1186/s12890-025-04028-7.
PubMed 41286729
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Functional and Qualitative Indicators of Critically Ill Patients With Respiratory Failure Using Different Physiotherapy Methods
- ClinicalTrials.gov ID
- NCT06912308
- Acronym / sponsor ID
- Protocol number 1 • Version 3
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Laura RutkauskienėUniversity, hospital or other
- Collaborators
- Lithuanian University of Health Sciences
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 4 Apr 2025 (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 aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. By conducting this study and developing the "Physiotherapy Protocol for Critically Ill Patients Treated in the ICU," physiotherapists worldwide could be encouraged to work using a unified and adapted method.
It is expected that the results, conclusions, and practical clinical recommendations derived from this study will be beneficial not only for rehabilitation specialists and intensivists in Lithuania but also for medical professionals working with respiratory diseases, including COVID-19 patients, at various stages of their treatment and consultation.
Implementing an appropriate physiotherapy procedure protocol is anticipated to bring economic benefits, as early physiotherapy is safe and can reduce the incidence of delirium, decrease the duration of patient sedation, shorten the number of days on mechanical ventilation, and minimize hospital stay duration. Additionally, it aims to restore or improve patients' functional and independence levels, help prevent ICU-acquired weakness, and can be easily implemented in intensive care units.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Physiotherapy Intervention Arm (n=75) | Experimental | Other: Active PhysiotherapyThe subjects of one group will receive active physiotherapy (eg: verticalization, sitting on the edge of the bed, active breathing exercises). |
| Passive Physiotherapy Intervention Arm (n=75) | Experimental | Other: Passive PhysiotherapyThe other group will receive passive physiotherapy methods (eg: passive movements, electrostimulation of the diaphragm). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years of age)
- Hospitalized in the Department of Reanimation and Intensive Therapy at LSMU Kaunas Clinics
- Diagnosis of respiratory failure (KFN) based on the following TLK-10-AM codes: J96.00, J96.01, J96.9, J96.10, J96.11, J96.19, J96.90, J96.91, J96.99
- Signed informed consent obtained from the patient or their legal representative
Key exclusion criteria (8 listed)
- Conscious patients who refuse to participate in the study
- Unconscious patients whose legal representative does not consent
- Recent episode of myocardial ischemia
- Pregnancy
- Heart rate < 40 bpm or > 130 bpm
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 |
|---|---|---|
| Active PhysiotherapyInvolves patient-driven exercises such as verticalization, sitting on the edge of the bed, and active breathing exercises. | Other | Active Physiotherapy Intervention Arm (n=75) |
| Passive PhysiotherapyEmploys methods like passive movements and electrostimulation of the diaphragm, providing therapeutic benefits without requiring active patient engagement. | Other | Passive Physiotherapy Intervention Arm (n=75) |
Primary outcome
Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge
Time frame: From Day 1 of ICU admission to ICU discharge (up to 50 days)
Pulmonary function will be assessed using spirometry. The following parameters will be measured in liters and as percentages of predicted values: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1). Measurements will be taken on Day 1 (baseline) and at ICU discharge. The mean change in FVC and FEV1 will be calculated to assess respiratory improvement.
3 secondary outcomes
Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay
Time frame: From Day 1 of ICU admission to ICU discharge (up to 50 days)
Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session
Time frame: Immediately before and immediately after each physiotherapy session, up to 50 days during ICU stay
Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay
Time frame: From Day 1 of physiotherapy to ICU discharge (up to 50 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 41286729Rutkauskiene L, Kubilius R, Tamosuitis T. Early mobilization, breathing exercises and chest wall oscillation in patients with bilateral pneumonia disease in the intensive care unit: a randomized clinical trial. BMC Pulm Med. 2025 Nov 25;26(1):20. doi: 10.1186/s12890-025-04028-7.
- Individual participant dataSharing planned: No. For now, we do not have enough human and financial resources to share IPD, but if our circumstances change, we are open to reconsidering this decision.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Physiotherapy and Passive Physiotherapy in people with Respiratory Insufficiency, run by Laura Rutkauskienė at 1 site in Lithuania.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. 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 Lithuania. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge (time frame: From Day 1 of ICU admission to ICU discharge (up to 50 days)). 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 NCT06912308, 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 9 Apr 2025.