Rehabilitation of Patients From the ICU to the Post-hospital Phase

NCT ID: NCT06405529

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-01-31

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.

Conditions

Early Mobilization; Physiotherapy; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

During hospitalization in the ICU and ward, this group will perform a maximum of 10 minutes of exercises of the casual care per day.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type: EXPERIMENTAL

Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge

Intervention Type: OTHER

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.

Guidance Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Rehabilitation Group

After hospital discharge, this group will participate in a supervised exercise program twice a week for 8 weeks at the Rehabilitation Center.

Group Type: EXPERIMENTAL

Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge

Intervention Type: OTHER

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.

Interventions

Early and intensive mobilization protocol at the ICU and Rehabilitation post-hospital discharge

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ada Clarice Gastaldi

Professor, PhD Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

USP-2024

Identifier Type: -

Identifier Source: org_study_id