Clinical trial NCT06405529: Rehabilitation of Patients From the ICU to the Post-hospital Phase
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Mobilization
Physiotherapy
Rehabilitation
Keywords: Mechanical ventilation
Physiotherapy
Respiratory function
Functional capacity
Rehabilitation
Cost-effectiveness
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 206
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

  1. Absence of bradyarrhythmia (\< 50 bpm);
  2. Heart rate ≥ 150 bpm;
  3. Most recent lactate measurement ≤ 4.0mmol/L;
  4. 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;
  5. 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).

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Functional exercise capacity
timeFrame: Through study completion, an average of 5 year
Secondary outcomes:
measure: Clinical parameters
timeFrame: Through study completion, an average of 5 year
measure: Clinical parameters
timeFrame: Through study completion, an average of 5 year
measure: Clinical parameters
timeFrame: Through study completion, an average of 5 year
measure: Clinical parameters
timeFrame: Through study completion, an average of 5 year
measure: Severity indexes
timeFrame: Through study completion, an average of 5 year
measure: Severity indexes
timeFrame: Through study completion, an average of 5 year
measure: Pulmonary function
timeFrame: Through study completion, an average of 5 year
measure: Pulmonary function
timeFrame: Through study completion, an average of 5 year
measure: Pulmonary function
timeFrame: Through study completion, an average of 5 year
measure: Pulmonary function
timeFrame: Through study completion, an average of 5 year
measure: Mortality
timeFrame: Through study completion, an average of 5 year
measure: Cost-effectiveness
timeFrame: 12 months after study completion
Other outcomes:
Locations:
Study officials:
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