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NCT Number: NCT06653998

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

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.

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Key information

Conditions

Intensive Care Unit Acquired Weakness Intensive Care Unit Patients Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Univesitaria Colombia, Bogotá, Bogota D.C., Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early mobilization and rehabilitation

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Claudia Aristizábal

Other

Registry information

Official study title

Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients. A Prospective, Multicenter Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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