The Impact of Early Mobilization Protocol in Patients in the ICU

NCT ID: NCT01769846

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Mobilization protocol

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.

Group Type: EXPERIMENTAL

Early mobilization protocol

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early mobilization protocol

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Isabella Martins de Albuquerque

Professor DSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabella Albuquerque, DSc.

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Maria

Locations

University Hospital of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28538781 (View on PubMed)

Other Identifiers

07201712.8.0000.5346

Identifier Type: -

Identifier Source: org_study_id