The Impact of Early Mobilization Protocol in Patients in the ICU

NCT01769846 | Completed

• 1 other identifier: 07201712.8.0000.5346
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged immobilization. Patients in the intensive care unit (ICU) are often confined to their beds, which results in inactivity, immobility, and severe osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength, perceived functional status, gait speed, quality of life, duration of mechanical ventilation, ICU length of stay of the critically ill patient. The purpose of this study is to evaluate the effects of implementation an early mobilization protocol in critically ill patients in the Intensive Care Unit of the University Hospital of Santa Maria.

Conditions

Muscle Weakness; Quality of Life; Weaning Acceleration; ICU Length of Stay; Muscle Thickness of the Quadriceps Femoris

Outcome Measures

Primary Outcomes (2)

• Muscle thickness (MT) of the quadriceps femoris.

  MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).

  Change from baseline at 14 day of ICU admission, an average of 1 month.

• Muscle thickness (MT) of the diaphragm.

  MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).

  Change from baseline at 14 day of ICU admission, an average of 1 month.

Secondary Outcomes (12)

• Rectus femoris cross-sectional area

  Change from baseline at 14 day of ICU admission, an average of 1 month.

• Vastus intermedius, rectus femoris and diaphragm echo intensity.

  Change from baseline at 14 day of ICU admission, an average of 1 month.

• Rectus femoris and vastus intermedius thickness.

  Change from baseline at 14 day of ICU admission, an average of 1 month.

• Muscle strength

  First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.

• Gait speed

  Study completion, an average of 2 months (hospital discharge)

Study Arms (2)

Early Mobilization protocol

EXPERIMENTAL

Early Mobilization protocol: Patients in the treatment group additionally received a progressive cycling exercise session 7 days a week, until the last day of ICU stay, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH \& Co. KG, Betzenweiler, Germany). Cycling exercise will be realized during 30 consecutive minutes, initially in continuos and passive (classified patients with RASS - 4) exercise, at a fixed pedaling rate of 20 cycles/min and after in actively (classified patients with RASS 0), with an exercise intensity of 3-5 on the Borg rate of perceived exertion scale.

Other: Early mobilization protocol

Control group

NO INTERVENTION

Group will undergo usual mobilization per standard ICU care. Conventional physical and respiratory therapy were provided by the ICU physical therapists twice daily, for approximately 30 min, 7 days per week. The protocol included vibrocompression maneuvers; lung hyperinflation by the mechanical ventilator; and tracheal aspiration, when necessary; as well as passive and active-assisted motor exercises for arms and legs, depending on the clinical course of patients.

Interventions

Early mobilization protocol OTHER

Patients in the treatment group additionally received a cycling exercise session 7 days a week, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH \& Co. KG, Betzenweiler, Germany). The device offers the possibility to conduct passive or active cycling at six levels of increasing resistance. The aim of each session was to have the patient cycle for 30 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position.

Early Mobilization protocol

Eligibility Criteria

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

You may qualify if:

• Adults (18 years of age or greater)
• Patients in the first 24 hours of mechanical ventilation.
• Patients in the deep sedation will be evaluated by the Richmond Agitation-Sedation Scale (score -4).
• Hemodynamically stable.

You may not qualify if:

• Rapidly developing neuromuscular disease
• Evolution of brain death
• Cardiopulmonary arrest
• Elevated intracranial pressure
• Ruptured/leaking aortic aneurysm
• Acute MI before peak troponin has been reached
• Absent lower limb
• Pregnancy
• Unstable fractures contributing to likely immobility
• Hospitalization prior to ICU admission \>5 days
• Enrollment in another clinical trial

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

University Hospital of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Location

Related Publications (1)

• Machado ADS, Pires-Neto RC, Carvalho MTX, Soares JC, Cardoso DM, Albuquerque IM. Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial. J Bras Pneumol. 2017 Mar-Apr;43(2):134-139. doi: 10.1590/S1806-37562016000000170.

  PMID: 28538781 DERIVED

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabella Albuquerque, DSc.

  Universidade Federal de Santa Maria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor DSc.

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 17, 2013
• Study Start: March 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

BR (1)