Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients

October 21, 2024 updated by: Claudia Aristizábal

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Bogota
      • Bogotá, Bogota, Colombia, 110111
        • Recruiting
        • Clínica Reina Sofia Pediátrica y Mujer
        • Contact:
    • Bogotá D.C.
      • Bogotá, Bogotá D.C., Colombia
        • Recruiting
        • Clinica Univesitaria Colombia
        • Contact:
      • Bogotá, Bogotá D.C., Colombia
        • Recruiting
        • Clínica Infantil Santa María del Lago
        • Contact:
      • Bogotá, Bogotá D.C., Colombia
        • Recruiting
        • Clínica Reina Sofia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients ≥ 18 years of age admitted to the intensive care units.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intensive care unit patients
Patients aged ≥ 18 years admitted to intensive care units and receiving the institutional early mobilisation protocol.
Other: Early mobilization and rehabilitation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
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.
During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
It will be assessed using the ICU Mobility Scale.
During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
It will be measured with pulse oximeter.
During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Respiratory rate
Time Frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
It will be measured with pulse oximeter.
During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claudia Aristizábal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Motionlife Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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