Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients

University of Sao Paulo General Hospital

Status: Completed

Conditions: Critical Illness; Muscle Weakness

Treatments: Other: Conventional Physical Therapy; Other: Respiratory therapy; Other: Early and progressive mobilization program

Study type: Interventional

Funder types: Other

Identifiers

NCT02889146

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Details and patient eligibility

About

The purpose of this study is to verify if a protocol of early and progressive mobility which includes the use of technology is able to increase the level of physical activity and improve functionality and respiratory and muscular function of Intensive Care Unit patients compared with conventional Physical Therapy.

Full description

The evolution of treatment in the Intensive Care Unit (ICU) has increased the survival and morbidity post hospital. Functional disability in these patients has its main factor in the weakness and loss of muscle mass, which is the major complications reported by these patients. The most negative result in long-term post ICU is the impact on quality of life and functional decline due to muscle disorders and fitness. This is achieved by the period of inactivity and prolonged rest, leading to losses and changes in various body systems. Given these facts, interventions for greater mobility in bed and out of it are very important. Early mobility programs has proved beneficial, however, as in other types of rehabilitation, the exercises should be prescribed with its specific characteristics, including the intensity. However, little has been described in the researches abut the activity level in the ICU, and using a quantitative measure. The use of technology seems to facilitate the offering of this type of therapy, supplying the limitations. Therefore, there are little evidences about these topics and randomized controlled studies to investigate these factors.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• admitted to the Emergency Intensive Care Unit of Clinical Hospital, Medical School, University os Sao Paulo
• inspired oxygen fraction ≤ 60%
• positive end expiratory pressure ≤ 10 points
• peripheral oxygen saturation ≥ 90%
• respiratory rate ≤ 35
• without cardiac arrhythmia or acute ischaemia
• heart rate > 50 bpm and < 140 bpm
• without high or raising dose of vasoactive drugs
• mean body pressure > 60 mmHg and < 120 mmHg
• without active bleeding
• without prescribed bedrest

Exclusion criteria

• transference from other hospital
• diagnosis of neurological disorders
• intensive care unit stay < 4 days
• contraindication to mobilization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 2 patient groups

Control group

Active Comparator group

Description:

Conventional Physical Therapy: motor physical therapy delivered by the intensive care unit physical therapists, according to his own criteria, without following any protocol. Respiratory therapy.

Treatment:

Other: Conventional Physical Therapy

Other: Respiratory therapy

Protocol group

Experimental group

Description:

Early and progressive mobilization program: motor physical therapy delivered by a trained physical therapist according to the mobilization protocol, in which patient progress according to his performance. Respiratory therapy.

Treatment:

Other: Respiratory therapy

Other: Early and progressive mobilization program