Early MobilizationNCT06405529
Rehabilitation of Patients From the ICU to the Post-hospital Phase
A study testing Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge in people with Early Mobilization and Physiotherapy, run by University of Sao Paulo.
Trial summary
Introduction: Advances in knowledge have contributed to the increase in the number of patients who survive prolonged hospitalization in an Intensive Care Unit (ICU), and, among them, critically ill patients who develop acute respiratory failure and need for mechanical ventilation. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Mobilization, Physiotherapy, Rehabilitation
- What is being tested?
- Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Jan 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both sexes
- Age greater than or equal to 21 years
- Be on invasive mechanical ventilation (IMV) for at least 48 hours
- Sufficient cardiovascular stability for mobilization
- Absence of bradyarrhythmia (< 50 bpm);
- Heart rate ≥ 150 bpm;
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- Most recent lactate measurement ≤ 4.0mmol/L;
- Combined adrenaline/noradrenaline infusion rate ≤ 0.2mcg/Kg/min, OR if the adrenaline/noradrenaline infusion was increased by more than 25% in the last 6 hours;
- Cardiac index ≥ 2.0L/min/m2; when evaluated
- Respiratory stability sufficient for mobilization f) Respiratory rate ≤ 45rpm; g) FiO2 ≤ 0.6; h) PEEP ≤ 16 cmH2O; i) No need for NO (nitric oxide), prone position, neuromuscular blocker, ECMO (extracorporeal membrane oxygenation) or HFOV (high frequency ventilation).
Who cannot join
- Dependent for ADLs in the month prior to ICU admission;
- Diagnosed cognitive deficit;
- Diagnosis OR suspicion of acute primary brain disease (TBI, stroke);
- Diagnosis OR suspected spinal cord injury OR other neuromuscular disease that may result in prolonged or permanent muscle weakness (except muscle weakness acquired in the ICU);
- Need OR instructions to remain in bed OR not to bear weight on the lower limbs bilaterally;
- Life expectancy of less than 180 days due to acute or chronic clinical conditions;
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- Death considered inevitable due to current clinical condition or if the patient/clinical guardian is not committed to complete active treatment (e.g. brain death);
- Inability to communicate in Portuguese;
- Readmission to the ICU of the same hospital service;
- Pregnant women;
- Patients with a permanent pacemaker.
About this study
Official title: Rehabilitation of Patients Submitted to Mechanical Ventilation, From the ICU to the Post-hospital Phase: Blinded Randomized Controlled Clinical Trial, With Economic and Multicenter Evaluation
Introduction: Advances in knowledge have contributed to the increase in the number of patients who survive prolonged hospitalization in an Intensive Care Unit (ICU), and, among them, critically ill patients who develop acute respiratory failure and need for mechanical ventilation. These individuals have their mobility restricted to bed, and may suffer from pulmonary and systemic complications, such as ICU-Acquired Muscle Weakness, which increases the chances of resulting in reduced functional capacity or death. Early mobilization in the ICU has demonstrated benefits, but still with a low level of evidence. However, the type and intensity of exercise still need to be better defined, and previous protocols did not offer continuous monitoring from the ICU to the ward and subsequent outpatient rehabilitation for these patients, which is considered a limitation in some studies.
Objective: To investigate the effects of an early and intensive hospital mobilization and post-hospital rehabilitation program on indicators of functionality, inflammation, cost-effectiveness, and mortality in critically ill patients undergoing invasive mechanical ventilation.
Methods: This is a Blind Randomized Controlled Clinical Trial that will be conducted in the ICUs of the Hospital das Clinicas and the Emergency Unit of the Faculty of Medicine of Ribeirao Preto of the University of São Paulo. Patients of both sexes over 21 years of age who have been under invasive mechanical ventilation for at least 24 hours will be recruited. Patients will be randomized into the Intervention Group (IG), with 30 to 60 minutes of exercise per day, and the Control Group (CG), with 10 minutes of exercise per day, both with the same protocol and based on the ICU Mobility Scale - IMS, with continuity in the ward. After hospital discharge, participants will be allocated to the Guidance Group (GIor and GCor) and the Outpatient Rehabilitation Group (GIreab and GCreab), with functional exercise capacity as the main outcome, assessed by the six-minute walk test (6MWT). Volunteers will be monitored one, three, and six months after hospital discharge. The sample calculation was based on the results of the 6MWT , with a power of 80% for the assessments carried out at the proposing institution (n=206), and with a power of 90% for the multicenter project (n=275), considering a sample loss of 30%. The following will be evaluated: clinical parameters, severity indexes, functionality, lung function and mechanics, functional exercise capacity, mortality, inflammatory markers, energy expenditure, activities of daily living, quality of life, muscle assessment, adherence, barriers and facilitators and cost-effectiveness.
- Conditions
- Early Mobilization, Physiotherapy, Rehabilitation
- Being tested
- Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge
- Keywords
- Mechanical ventilation, Physiotherapy, Respiratory function, Functional capacity, Rehabilitation, Cost-effectiveness
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital dischargeOther
During hospitalization in the ICU and ward, you will perform 30 to 60 minutes of exercises per day, according to the IMS scale.
After hospital discharge, participation in a supervised exercise program twice a week for 8 weeks at the Rehabilitation Center - CER of the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | During hospitalization in the ICU and ward, this group will perform a maximum of 10 minutes of exercises of the casual care per day. |
| Intervention Group | Experimental | During hospitalization in the ICU and ward, this group will perform 30 to 60 minutes of exercises per day, according to the IMS scale and the intensive mobilization protocol. Receives: Other: Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge |
| Guidance Group | No intervention | After hospital discharge, this group will not participate in any supervised exercise session, they will only be instructed by the therapists and receive the exercise booklet from the Rehabilitation Center. |
| Rehabilitation Group | Experimental | After hospital discharge, this group will participate in a supervised exercise program twice a week for 8 weeks at the Rehabilitation Center. Receives: Other: Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Assessed by the 6-minute walk test
Measured: Through study completion, an average of 5 year
Secondary outcomes (12)
Clinical parameters
Hemodynamic data will be evaluated beafore and after the mobilization protocol
Measured: Through study completion, an average of 5 year
Clinical parameters
Level of sedation evaluated by the Richmond Agitation-Sedation Scale (RASS). The scale ranges from -4 to +5, from the highest level of agitation to coma.
Measured: Through study completion, an average of 5 year
Clinical parameters
Length of stay in the ICU (tICU) and Length of hospital stay (LoS)
Measured: Through study completion, an average of 5 year
Clinical parameters
Time on mechanical ventilation (tMV)
Measured: Through study completion, an average of 5 year
Severity indexes
Acute Physiologic and Chronic Health Evaluation II Score (APACHE II). This tool assesses the severity of the disease and mortality of patients admitted to the ICU, consisting of 12 variables that include: age, past medical history, as well as clinical and physiological indices.
Measured: Through study completion, an average of 5 year
Severity indexes
Sequential Organ Failure Assessment Score (SOFA Score). This tool calculates both the number and severity of organic dysfunction in six organic systems (respiratory, coagulation, hepatic, cardiovascular, renal and neurological).
Measured: Through study completion, an average of 5 year
Pulmonary function
Spirometry will be used as a tool to assess the lung function. The test will be performed by every volunteer and the measurement will be done by guidelines of the Brazilian Society of Pulmonology and Phthisiology for lung function tests.
Measured: Through study completion, an average of 5 year
Pulmonary function
Impulse oscillometry system (IOS). This test will be perfomed to evaluate the resistance of the respiratory system in accordance with that proposed by Oosteveen (2003).
Measured: Through study completion, an average of 5 year
Pulmonary function
Diffusing capacity of the lungs for carbon monoxide (DLCO). This is a pulmonary function test used to assess the lungs' ability to transfer gas from inspired air to the bloodstream. Normal severity slassification is up to 75% of the predicted value.
Measured: Through study completion, an average of 5 year
Pulmonary function
Computed tomography (CT). The high-resolution CT technique with low dose of radiation will be used, without the administration of iodinated contrast medium, scanning the entire chest in the caudocranial direction, with volumetric acquisition of 1 mm in thickness during complete inspiration. Quantitative analysis of HRCT images will be performed using the scientific program Yacta version 2.8 (Heussel et al., 2009).
Measured: Through study completion, an average of 5 year
Mortality
Measured: Through study completion, an average of 5 year
Cost-effectiveness
Economic evaluation - Patient and Institution costs
Measured: 12 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 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 Early MobilizationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ada Clarice Gastaldi, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405529
- Sponsor's protocol ID
- USP-2024
- Status last verified
- May 2024
- First submitted
- 7 Jan 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gastaldi AC, Biazon TMPC, Basile-Filho A, Dos Santos DO, Tambascio J, Perossi J, Silveira JM, da Silva MG, Wilches-Lunae EC, Usmani O, de Oliveira AS. A protocol for the rehabilitation of patients undergoing mechanical ventilation from the ICU to the post-hospital phase: the MOVE-ICUtoHOME, a multicentre randomised controlled trial. BMJ Open Respir Res. 2026 Aug 20;13(1):e004039. doi: 10.1136/bmjresp-2025-004039.
PubMed 42624643
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Patients Submitted to Mechanical Ventilation, From the ICU to the Post-hospital Phase: Blinded Randomized Controlled Clinical Trial, With Economic and Multicenter Evaluation
- ClinicalTrials.gov ID
- NCT06405529
- Acronym / sponsor ID
- USP-2024
- Conditions
- Early Mobilization, Physiotherapy, Rehabilitation
- Keywords
- Mechanical ventilation, Physiotherapy, Respiratory function, Functional capacity, Rehabilitation, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 May 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.
Introduction: Advances in knowledge have contributed to the increase in the number of patients who survive prolonged hospitalization in an Intensive Care Unit (ICU), and, among them, critically ill patients who develop acute respiratory failure and need for mechanical ventilation. These individuals have their mobility restricted to bed, and may suffer from pulmonary and systemic complications, such as ICU-Acquired Muscle Weakness, which increases the chances of resulting in reduced functional capacity or death. Early mobilization in the ICU has demonstrated benefits, but still with a low level of evidence. However, the type and intensity of exercise still need to be better defined, and previous protocols did not offer continuous monitoring from the ICU to the ward and subsequent outpatient rehabilitation for these patients, which is considered a limitation in some studies.
Objective: To investigate the effects of an early and intensive hospital mobilization and post-hospital rehabilitation program on indicators of functionality, inflammation, cost-effectiveness, and mortality in critically ill patients undergoing invasive mechanical ventilation.
Methods: This is a Blind Randomized Controlled Clinical Trial that will be conducted in the ICUs of the Hospital das Clinicas and the Emergency Unit of the Faculty of Medicine of Ribeirao Preto of the University of São Paulo. Patients of both sexes over 21 years of age who have been under invasive mechanical ventilation for at least 24 hours will be recruited. Patients will be randomized into the Intervention Group (IG), with 30 to 60 minutes of exercise per day, and the Control Group (CG), with 10 minutes of exercise per day, both with the same protocol and based on the ICU Mobility Scale - IMS, with continuity in the ward. After hospital discharge, participants will be allocated to the Guidance Group (GIor and GCor) and the Outpatient Rehabilitation Group (GIreab and GCreab), with functional exercise capacity as the main outcome, assessed by the six-minute walk test (6MWT). Volunteers will be monitored one, three, and six months after hospital discharge. The sample calculation was based on the results of the 6MWT , with a power of 80% for the assessments carried out at the proposing institution (n=206), and with a power of 90% for the multicenter project (n=275), considering a sample loss of 30%. The following will be evaluated: clinical parameters, severity indexes, functionality, lung function and mechanics, functional exercise capacity, mortality, inflammatory markers, energy expenditure, activities of daily living, quality of life, muscle assessment, adherence, barriers and facilitators and cost-effectiveness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –During hospitalization in the ICU and ward, this group will perform a maximum of 10 minutes of exercises of the casual care per day. |
| Intervention Group | Experimental | Other: Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital dischargeDuring hospitalization in the ICU and ward, this group will perform 30 to 60 minutes of exercises per day, according to the IMS scale and the intensive mobilization protocol. |
| Guidance Group | No intervention | –After hospital discharge, this group will not participate in any supervised exercise session, they will only be instructed by the therapists and receive the exercise booklet from the Rehabilitation Center. |
| Rehabilitation Group | Experimental | Other: Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital dischargeAfter hospital discharge, this group will participate in a supervised exercise program twice a week for 8 weeks at the Rehabilitation Center. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Both sexes
- Age greater than or equal to 21 years
- Be on invasive mechanical ventilation (IMV) for at least 48 hours
- Sufficient cardiovascular stability for mobilization
- Respiratory stability sufficient for mobilization f) Respiratory rate ≤ 45rpm; g) FiO2 ≤ 0.6; h) PEEP ≤ 16 cmH2O; i) No need for NO (nitric oxide), prone position, neuromuscular blocker, ECMO (extracorporeal membrane oxygenation) or HFOV (high frequency ventilation).
Key exclusion criteria (11 listed)
- Dependent for ADLs in the month prior to ICU admission;
- Diagnosed cognitive deficit;
- Diagnosis OR suspicion of acute primary brain disease (TBI, stroke);
- Diagnosis OR suspected spinal cord injury OR other neuromuscular disease that may result in prolonged or permanent muscle weakness (except muscle weakness acquired in the ICU);
- Need OR instructions to remain in bed OR not to bear weight on the lower limbs bilaterally;
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 and intensive mobilization protocol at the ICU and Rehabilitation post-hospital dischargeDuring hospitalization in the ICU and ward, you will perform 30 to 60 minutes of exercises per day, according to the IMS scale. After hospital discharge, participation in a supervised exercise program twice a week for 8 weeks at the Rehabilitation Center - CER of the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto. | Other | Intervention Group, Rehabilitation Group |
Primary outcome
Functional exercise capacity
Time frame: Through study completion, an average of 5 year
Assessed by the 6-minute walk test
12 secondary outcomes
Clinical parameters
Time frame: Through study completion, an average of 5 year
Clinical parameters
Time frame: Through study completion, an average of 5 year
Clinical parameters
Time frame: Through study completion, an average of 5 year
Clinical parameters
Time frame: Through study completion, an average of 5 year
Severity indexes
Time frame: Through study completion, an average of 5 year
Severity indexes
Time frame: Through study completion, an average of 5 year
Pulmonary function
Time frame: Through study completion, an average of 5 year
Pulmonary function
Time frame: Through study completion, an average of 5 year
Pulmonary function
Time frame: Through study completion, an average of 5 year
Pulmonary function
Time frame: Through study completion, an average of 5 year
Mortality
Time frame: Through study completion, an average of 5 year
Cost-effectiveness
Time frame: 12 months after study completion
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 8 May 2024.
- Derived from this study: PubMed 42624643Gastaldi AC, Biazon TMPC, Basile-Filho A, Dos Santos DO, Tambascio J, Perossi J, Silveira JM, da Silva MG, Wilches-Lunae EC, Usmani O, de Oliveira AS. A protocol for the rehabilitation of patients undergoing mechanical ventilation from the ICU to the post-hospital phase: the MOVE-ICUtoHOME, a multicentre randomised controlled trial. BMJ Open Respir Res. 2026 Aug 20;13(1):e004039. doi: 10.1136/bmjresp-2025-004039.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge in people with Early Mobilization and Physiotherapy, run by University of Sao Paulo.
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 10 inclusion and 11 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 8 May 2024. 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?
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?
Functional exercise capacity (time frame: Through study completion, an average of 5 year). 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 NCT06405529, 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 8 May 2024.