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The Impact of Early Mobilization Protocol in Patients in the ICU

U

Universidade Federal de Santa Maria

Status

Completed

Conditions

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

Treatments

Other: Early mobilization protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT01769846
07201712.8.0000.5346

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 2 patient groups

Early Mobilization protocol
Experimental group
Description:
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.
Treatment:
Other: Early mobilization protocol
Control group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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