Early MobilizationNCT07765017
Early Mobilization and Prolonged ICU Stay in Postoperative Patients
An observational study of Early Mobilization and Postoperative Care, run by Ankara Training and Research Hospital.
Trial summary
This prospective observational cohort study aims to evaluate early mobilization in adult postoperative patients admitted to the intensive care unit (ICU) and to investigate its association with short-term clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Mobilization, Postoperative Care
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 May 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult postoperative patients admitted to the intensive care unit of Ankara Training and Research Hospital who meet the predefined eligibility criteria will constitute the study population. Participants will be prospectively evaluated for early mobilization during their ICU stay and followed for the clinical outcomes specified in the study protocol.
Who may be able to join
- Age 18 years or older
- Admission to the intensive care unit for postoperative care
- ICU stay of at least 24 hours
- Ability to assess the patient's mobilization level within the first 24 hours following ICU admission
- Provision of informed consent for participation in the study
Who cannot join
- Age under 18 years
- Pregnancy
- Death within the first 24 hours after ICU admission
- Clinical conditions contraindicating mobilization, including active massive bleeding, significant hemodynamic instability, unstable fracture, open abdomen, or similar conditions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Early Mobilization and Prolonged Intensive Care Unit Stay in Postoperative Patients: A Prospective Observational Study
This prospective observational cohort study aims to evaluate early mobilization in adult postoperative patients admitted to the intensive care unit (ICU) and to investigate its association with short-term clinical outcomes. Early meaningful mobilization is defined as achieving at least sitting at the edge of the bed (mobilization level ≥4) within the first 24 hours after ICU admission. Patients will be classified according to whether early meaningful mobilization is achieved. The primary objective is to evaluate the association between early meaningful mobilization and prolonged ICU stay. Secondary outcomes include mechanical ventilation requirement and duration, hospital length of stay, need for reintubation, development of delirium, complications occurring during mobilization, and ICU mortality.
Read the detailed description
This is a prospective observational cohort study involving adult postoperative patients admitted to the intensive care unit (ICU). The study aims to systematically evaluate early mobilization practices and investigate the association between early mobilization and short-term clinical outcomes in postoperative ICU patients.
Mobilization performed within the first 24 hours after ICU admission will be evaluated according to predefined standardized criteria. Mobilization levels will be recorded using a scale ranging from passive movements to independent mobilization. Early meaningful mobilization is defined as achieving at least sitting at the edge of the bed (mobilization level ≥4) within the first 24 hours after ICU admission. Patients will be classified according to whether early meaningful mobilization is achieved.
The primary objective is to evaluate the association between early meaningful mobilization and prolonged ICU stay. Secondary objectives include evaluating its association with the requirement for and duration of mechanical ventilation, hospital length of stay, need for reintubation, development of delirium, complications occurring during mobilization, ICU mortality, and other early clinical outcomes.
Clinical factors potentially associated with the feasibility of early mobilization will also be evaluated. These include age, comorbidities, preoperative functional capacity, type and duration of surgery, APACHE II and SOFA scores at ICU admission, requirement for mechanical ventilation, vasopressor support, and sedation level. In patients who are not mobilized early, potential barriers to mobilization, including hemodynamic instability, respiratory insufficiency, deep sedation, pain, surgical restrictions, and organizational factors, will be recorded.
Patients will be followed throughout their ICU and hospital stay, and relevant clinical outcomes will be recorded. Demographic characteristics, surgical data, clinical parameters at ICU admission, mobilization status, and clinical outcomes will be collected using a standardized data collection form. All collected data will be anonymized for analysis.
No additional intervention or diagnostic test will be performed as part of the study. All study data will be obtained during routine clinical follow-up, directly from included patients, nursing observation forms, and electronic hospital records.
- Conditions
- Early Mobilization, Postoperative Care
- Keywords
- Early Mobilization, Postoperative Intensive Care, Intensive Care Unit, Prolonged ICU Stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early Meaningful Mobilization | Postoperative ICU patients who achieve a mobilization level of ≥4 within the first 24 hours after ICU admission. | |
| No Early Meaningful Mobilization | Postoperative ICU patients who do not achieve a mobilization level of ≥4 within the first 24 hours after ICU admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Intensive Care Unit Stay
Prolonged ICU stay will be evaluated according to the duration of ICU hospitalization and compared between patients who achieve early meaningful mobilization and those who do not. Early meaningful mobilization is defined as achieving a mobilization level of ≥4 within the first 24 hours after ICU admission.
Measured: Through ICU stay, an expected average of 3 days
Secondary outcomes (5)
Mechanical Ventilation Requirement
Requirement for invasive mechanical ventilation during the ICU stay
Measured: Through ICU stay, an expected average of 3 days
Duration of Mechanical Ventilation
Duration of invasive mechanical ventilation during the ICU stay, recorded in days.
Measured: Through ICU stay, an expected average of 3 days
Hospital Length of Stay
Total duration of hospitalization, recorded in days.
Measured: Through hospitalization, an expected average of 7 days
Reintubation Requirement
Occurrence of reintubation during the ICU stay.
Measured: Through ICU stay, an expected average of 3 days
ICU Mortality
All-cause mortality occurring during the ICU stay
Measured: Through ICU stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MobilizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kuzukiran Kocatas, Ankara Training and Research Hospital
- Investigators
- Dilek Kuzukıran Kocataş, MD, Principal investigator, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765017
- Sponsor's protocol ID
- E-26-954
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because data sharing with external researchers was not included in the approved study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Mobilization and Prolonged Intensive Care Unit Stay in Postoperative Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07765017
- Acronym / sponsor ID
- E-26-954
- Conditions
- Early Mobilization, Postoperative Care
- Keywords
- Early Mobilization, Postoperative Intensive Care, Intensive Care Unit, Prolonged ICU Stay
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 14 Aug 2026 (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.
This prospective observational cohort study aims to evaluate early mobilization in adult postoperative patients admitted to the intensive care unit (ICU) and to investigate its association with short-term clinical outcomes. Early meaningful mobilization is defined as achieving at least sitting at the edge of the bed (mobilization level ≥4) within the first 24 hours after ICU admission. Patients will be classified according to whether early meaningful mobilization is achieved. The primary objective is to evaluate the association between early meaningful mobilization and prolonged ICU stay. Secondary outcomes include mechanical ventilation requirement and duration, hospital length of stay, need for reintubation, development of delirium, complications occurring during mobilization, and ICU mortality.
Detailed description
This is a prospective observational cohort study involving adult postoperative patients admitted to the intensive care unit (ICU). The study aims to systematically evaluate early mobilization practices and investigate the association between early mobilization and short-term clinical outcomes in postoperative ICU patients.
Mobilization performed within the first 24 hours after ICU admission will be evaluated according to predefined standardized criteria. Mobilization levels will be recorded using a scale ranging from passive movements to independent mobilization. Early meaningful mobilization is defined as achieving at least sitting at the edge of the bed (mobilization level ≥4) within the first 24 hours after ICU admission. Patients will be classified according to whether early meaningful mobilization is achieved.
The primary objective is to evaluate the association between early meaningful mobilization and prolonged ICU stay. Secondary objectives include evaluating its association with the requirement for and duration of mechanical ventilation, hospital length of stay, need for reintubation, development of delirium, complications occurring during mobilization, ICU mortality, and other early clinical outcomes.
Clinical factors potentially associated with the feasibility of early mobilization will also be evaluated. These include age, comorbidities, preoperative functional capacity, type and duration of surgery, APACHE II and SOFA scores at ICU admission, requirement for mechanical ventilation, vasopressor support, and sedation level. In patients who are not mobilized early, potential barriers to mobilization, including hemodynamic instability, respiratory insufficiency, deep sedation, pain, surgical restrictions, and organizational factors, will be recorded.
Patients will be followed throughout their ICU and hospital stay, and relevant clinical outcomes will be recorded. Demographic characteristics, surgical data, clinical parameters at ICU admission, mobilization status, and clinical outcomes will be collected using a standardized data collection form. All collected data will be anonymized for analysis.
No additional intervention or diagnostic test will be performed as part of the study. All study data will be obtained during routine clinical follow-up, directly from included patients, nursing observation forms, and electronic hospital records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Meaningful Mobilization | – | –Postoperative ICU patients who achieve a mobilization level of ≥4 within the first 24 hours after ICU admission. |
| No Early Meaningful Mobilization | – | –Postoperative ICU patients who do not achieve a mobilization level of ≥4 within the first 24 hours after ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult postoperative patients admitted to the intensive care unit of Ankara Training and Research Hospital who meet the predefined eligibility criteria will constitute the study population. Participants will be prospectively evaluated for early mobilization during their ICU stay and followed for the clinical outcomes specified in the study protocol.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Admission to the intensive care unit for postoperative care
- ICU stay of at least 24 hours
- Ability to assess the patient's mobilization level within the first 24 hours following ICU admission
- Provision of informed consent for participation in the study
Key exclusion criteria (4 listed)
- Age under 18 years
- Pregnancy
- Death within the first 24 hours after ICU admission
- Clinical conditions contraindicating mobilization, including active massive bleeding, significant hemodynamic instability, unstable fracture, open abdomen, or similar conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prolonged Intensive Care Unit Stay
Time frame: Through ICU stay, an expected average of 3 days
Prolonged ICU stay will be evaluated according to the duration of ICU hospitalization and compared between patients who achieve early meaningful mobilization and those who do not. Early meaningful mobilization is defined as achieving a mobilization level of ≥4 within the first 24 hours after ICU admission.
5 secondary outcomes
Mechanical Ventilation Requirement
Time frame: Through ICU stay, an expected average of 3 days
Duration of Mechanical Ventilation
Time frame: Through ICU stay, an expected average of 3 days
Hospital Length of Stay
Time frame: Through hospitalization, an expected average of 7 days
Reintubation Requirement
Time frame: Through ICU stay, an expected average of 3 days
ICU Mortality
Time frame: Through ICU stay, an expected average of 3 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 14 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because data sharing with external researchers was not included in the approved study protocol.
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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.
Dilek Kuzukıran Kocataş, MD principal investigator
Ankara Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Early Mobilization and Postoperative Care, run by Ankara Training and Research Hospital.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dilek Kuzukıran Kocataş, MD (+905355261001, drdilek06@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Intensive Care Unit Stay (time frame: Through ICU stay, an expected average of 3 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 14 Aug 2026.