Intensive Care Unit Acquired WeaknessNCT06653998
Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients
An observational study of Intensive Care Unit Acquired Weakness and Intensive Care Unit Patients, run by Claudia Aristizábal at 4 sites in Colombia.
Trial summary
Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Intensive Care Unit Patients
- What is being tested?
- Early mobilization and rehabilitation
- How many people
- 220 participants
- Where
- 4 sitesColombia
- Study dates
- 10 May 2024to Apr 2025
- Phase
- Observational
- 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
Study population: Patients ≥ 18 years of age admitted to the intensive care units of Clínica Reina Sofía, Clínica Universitaria Colombia, Clínica Reina Sofia and Clínica Santa María del Lago in Bogotá.
Who may be able to join
- Patients ≥ 18 years of age admitted to the intensive care units.
Who cannot join
- Patients requiring extracorporeal membrane oxygenation (ECMO).
- Patients without indication for early mobilisation in the ICU (severe hemodynamic instability, acute brain or spinal injury with rest orders, anaemia (Hb \<8 mg/dl), thrombocytopenia (platelets \<50,000), active systemic inflammatory response according to institutional protocols).
- Patients in the postoperative period of cardiac transplantation.
Trial locations and contacts
4 sites in 1 country.
Colombia4 sites, 4 recruiting
- Recruiting
Clínica Reina Sofia Pediátrica y Mujer
Bogotá, Bogota D.C., 110111
Janneth Avendaño, MSc., +57 6017455100, jannethluna2023@gmail.com
- Recruiting
Clinica Univesitaria Colombia
Bogotá, Bogota D.C.
Johana Melo, Specialization, +57 6017058333 ext. 5715069, johanaemv91@gmail.com
- Recruiting
Clínica Infantil Santa María del Lago
Bogotá, Bogota D.C.
Pilar Mogollón, MSc., +57 6014306767, pilarmogollon@hotmail.com
- Recruiting
Clínica Reina Sofia
Bogotá, Bogota D.C.
Mauricio Parada, MSc., +57 6017436767, maoparada1606@gmail.com
About this study
Official title: Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients. A Prospective, Multicenter Study
Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration.
The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.
Read the detailed description
Prolonged immobilisation, mechanical ventilation, and sedation during critical illness have been associated with generalized muscle weakness, restricted joint mobility, pressure ulcers, critical illness neuropathies or acquired weakness, deep vein thrombosis (DVT), prolonged mechanical ventilation, psychological disorders, and cognitive impairment. Barriers to early mobilisation have been identified, including patient-related, institution-related, and physician-related barriers, and various strategies have been used to overcome these barriers and facilitate the smooth practice of early mobilisation.
Early mobilisation, initiated within 24-48 hours of Intensive Care Unit (ICU) admission, has been shown to be the best strategy for reducing ICU-acquired weakness (ICUAW). It includes a variety of interventions: passive for non-cooperative patients (e.g., positioning, passive joint mobilisation) and active-assisted or active for less or fully cooperative patients (e.g., active or active-assisted joint mobilisation, sitting on bed or chair, transfers, standing, ambulation). Several studies have provided evidence that progressive early mobilisation of adult ICU patients is feasible, safe, and can yield benefits including improved functional outcomes and reduced ICU and hospital stay durations.
Successful implementation of an early physical rehabilitation program in most ICUs requires a structured process to promote quality improvement. This involves a multidisciplinary approach including hospital administrators, ICU and rehabilitation leaders who support the program and promote a culture change within the ICU. It also requires assembling a multidisciplinary team including intensivists, nursing, clinical nutrition, physical medicine, and rehabilitation; establishing a common goal and shared expectation of early rehabilitation for all patients with focused efforts to identify and overcome barriers to achieving this goal; and obtaining basic equipment to facilitate early rehabilitation.
- Being tested
- Early mobilization and rehabilitation
- Keywords
- Intensive Care Units, Muscle Weakness, Early Mobilization, Rehabilitation
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilization and rehabilitationOther
In the initial assessment will be applied the ICU Mobility Scale, with the objective of establishing the patient\'s current level of function and determining the most appropriate type, intensity and duration of activity.
The sessions, which will be conducted by a physiotherapist, will include therapeutic strategies such as bed exercises (both active and passive), electrical stimulation, use of an in-bed cycloergometer (for upper and lower limbs), sitting on the edge of the bed, bed transfers, bedside transfers from bed to chair, out-of-bed exercises, standing, and walking. The latter two activities are considered to be the most complex. Each session will last approximately 20 to 30 minutes and will be conducted once a day, on a daily basis throughout the patient\'s ICU stay. The last session wil be prior to discharge of the patient.
During each session, the Borg Perception of Exertion Scale will be assessed in order to adjust the intensity of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care unit patients | Patients aged ≥ 18 years admitted to intensive care units and receiving the institutional early mobilisation protocol. Receives: Other: Early mobilization and rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viability
This is the number of sessions performed by the patient.
Measured: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Safety event
This is the number of safety events related with the intervention. The following safety events will be measured: Accidental removal of central venous catheter, accidental removal of endotracheal tube, accidental removal of arterial line, accidental removal of nasogastric or orogastric tube, accidental removal of bladder catheter, high or low blood pressure, tachycardia, bradycardia, arrhythmia, y polypnoea.
Measured: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Secondary outcomes (1)
Degree of ability achieved
It will be assessed using the ICU Mobility Scale.
Measured: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start10 May 2024
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653998
- Sponsor's protocol ID
- Motionlife Study
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parada-Gereda HM, Merchan-Chaverra R, Medina-Parra J, Benavides-Cruz J, Gaitan-Duarte H. Safety of early mobilisation in the intensive care unit: a prospective and multicentre cohort study protocol. BMJ Open. 2025 Aug 26;15(8):e101772. doi: 10.1136/bmjopen-2025-101772.
PubMed 40858383
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients. A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT06653998
- Acronym / sponsor ID
- Motionlife Study
- Keywords
- Intensive Care Units, Muscle Weakness, Early Mobilization, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Oct 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.
Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration.
The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.
Detailed description
Prolonged immobilisation, mechanical ventilation, and sedation during critical illness have been associated with generalized muscle weakness, restricted joint mobility, pressure ulcers, critical illness neuropathies or acquired weakness, deep vein thrombosis (DVT), prolonged mechanical ventilation, psychological disorders, and cognitive impairment. Barriers to early mobilisation have been identified, including patient-related, institution-related, and physician-related barriers, and various strategies have been used to overcome these barriers and facilitate the smooth practice of early mobilisation.
Early mobilisation, initiated within 24-48 hours of Intensive Care Unit (ICU) admission, has been shown to be the best strategy for reducing ICU-acquired weakness (ICUAW). It includes a variety of interventions: passive for non-cooperative patients (e.g., positioning, passive joint mobilisation) and active-assisted or active for less or fully cooperative patients (e.g., active or active-assisted joint mobilisation, sitting on bed or chair, transfers, standing, ambulation). Several studies have provided evidence that progressive early mobilisation of adult ICU patients is feasible, safe, and can yield benefits including improved functional outcomes and reduced ICU and hospital stay durations.
Successful implementation of an early physical rehabilitation program in most ICUs requires a structured process to promote quality improvement. This involves a multidisciplinary approach including hospital administrators, ICU and rehabilitation leaders who support the program and promote a culture change within the ICU. It also requires assembling a multidisciplinary team including intensivists, nursing, clinical nutrition, physical medicine, and rehabilitation; establishing a common goal and shared expectation of early rehabilitation for all patients with focused efforts to identify and overcome barriers to achieving this goal; and obtaining basic equipment to facilitate early rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit patients | – | Other: Early mobilization and rehabilitationPatients aged ≥ 18 years admitted to intensive care units and receiving the institutional early mobilisation protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years of age admitted to the intensive care units of Clínica Reina Sofía, Clínica Universitaria Colombia, Clínica Reina Sofia and Clínica Santa María del Lago in Bogotá.
Key inclusion criteria (1 listed)
- Patients ≥ 18 years of age admitted to the intensive care units.
Key exclusion criteria (3 listed)
- Patients requiring extracorporeal membrane oxygenation (ECMO).
- Patients without indication for early mobilisation in the ICU (severe hemodynamic instability, acute brain or spinal injury with rest orders, anaemia (Hb \<8 mg/dl), thrombocytopenia (platelets \<50,000), active systemic inflammatory response according to institutional protocols).
- Patients in the postoperative period of cardiac transplantation.
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 |
|---|---|---|
| Early mobilization and rehabilitationIn the initial assessment will be applied the ICU Mobility Scale, with the objective of establishing the patient\'s current level of function and determining the most appropriate type, intensity and duration of activity. The sessions, which will be conducted by a physiotherapist, will include therapeutic strategies such as bed exercises (both active and passive), electrical stimulation, use of an in-bed cycloergometer (for upper and lower limbs), sitting on the edge of the bed, bed transfers, bedside transfers from bed to chair, out-of-bed exercises, standing, and walking. The latter two activities are considered to be the most complex. Each session will last approximately 20 to 30 minutes and will be conducted once a day, on a daily basis throughout the patient\'s ICU stay. The last session wil be prior to discharge of the patient. During each session, the Borg Perception of Exertion Scale will be assessed in order to adjust the intensity of physical activity. | Other | Intensive care unit patients |
Primary outcome
Viability
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
This is the number of sessions performed by the patient.
Safety event
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
This is the number of safety events related with the intervention. The following safety events will be measured: Accidental removal of central venous catheter, accidental removal of endotracheal tube, accidental removal of arterial line, accidental removal of nasogastric or orogastric tube, accidental removal of bladder catheter, high or low blood pressure, tachycardia, bradycardia, arrhythmia, y polypnoea.
1 secondary outcome
Degree of ability achieved
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 40858383Parada-Gereda HM, Merchan-Chaverra R, Medina-Parra J, Benavides-Cruz J, Gaitan-Duarte H. Safety of early mobilisation in the intensive care unit: a prospective and multicentre cohort study protocol. BMJ Open. 2025 Aug 26;15(8):e101772. doi: 10.1136/bmjopen-2025-101772.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Acquired Weakness and Intensive Care Unit Patients, run by Claudia Aristizábal at 4 sites in Colombia.
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 3 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: status not confirmed, as of the sponsor's last update on 23 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 4 sites in Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability (time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.). The study lists 2 primary outcomes in all. 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 NCT06653998, 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 23 Oct 2024.