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

NCT06653998 | Recruiting DMC

• 1 other identifier: Motionlife Study
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Intensive Care Unit Acquired Weakness; Intensive Care Unit Patients

Keywords

Intensive Care Units; Muscle Weakness; Early Mobilization; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Viability

  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

  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 Outcomes (1)

• Degree of ability achieved

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

Other Outcomes (2)

• Heart rate

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

• Respiratory rate

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

Study Arms (1)

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

Interventions

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.

Intensive care unit patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claudia Aristizábal: lead

Study Sites (4)

Clínica Reina Sofia Pediátrica y Mujer

Bogotá, Bogota D.C., 110111, Colombia

RECRUITING

Clinica Univesitaria Colombia

Bogotá, Bogota D.C., Colombia

RECRUITING

Clínica Infantil Santa María del Lago

Bogotá, Bogota D.C., Colombia

RECRUITING

Clínica Reina Sofia

Bogotá, Bogota D.C., Colombia

RECRUITING

Related Publications (1)

• Parada-Gereda HM, Merchan-Chaverra R, Medina-Parra J, Benavides-Cruz J, Gaitan-Duarte H. Safety of early mobilisation in the intensive care unit: a prospective and multicentre cohort study protocol. BMJ Open. 2025 Aug 26;15(8):e101772. doi: 10.1136/bmjopen-2025-101772.

  PMID: 40858383 DERIVED

MeSH Terms

Conditions

Muscle Weakness

Interventions

Early Ambulation; Rehabilitation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 23, 2024
• Study Start: May 10, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

CO (4)