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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
98
Control group will receive respiratory therapy according to the service routine and conventional physical therapy. Conventional physical therapy will be offered by the hospital physical therapists, according to their own criteria. Consists of passive, assisted and resisted mobilization, positioning in bed, transferring to bedside or chair, orthostatism and deambulation, however without a definition of a protocol. The physical therapist will be responsible for the choice of the techniques employed in each session. There will be no previous definition of the next sessions. No technology equipment will be used in this group, since they are not available in the routine care.
Protocol group will receive respiratory therapy according to the service routine and motor physical therapy according to the program of early and progressive mobilization. Patients will receive the program once daily during the intensive care unit stay, offered by a trained physical therapist, at the adequate level according to the level of consciousness and muscle strength. The program contains by techniques for muscle length and muscle strength maintenance or gain, aerobic exercises, exercises for gait rehabilitation and cognitive components. Patient will progress to the next level of the protocol completing the previous level. Technology equipment available: functional electrical stimulation device, dumbbells, cycle ergometer, fixed walker, ambulation assistive device and video game.
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
São Paulo, São Paulo, Brazil
Functional status
Ability to perform daily living activities assessed by Barthel Index
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Level of physical activity during the whole intensive care unit stay
Level of physical activity measured by an accelerometer
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Pulmonary function
Pulmonary function assessed by a spirometer
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Maximum inspiratory pressure
Maximum inspiratory pressure measured by an specific equipment
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Peripheral muscle strength
Muscle strength assessed by hand grip dynamometer
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Electromyography muscle activity
Quadriceps femoris electric activity assessed by surface electromyography
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Muscle function and mobility
Test by Time up and Go
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Intensive care unit length of stay
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Respiratory therapy according to the service routine.
Count of the number of days spent at the intensive care unit
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Correlation between physiological variables and the level of physical activity
Correlation between the physiological variables collected during the study and the level of physical activity measured by the accelerometer
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
ICU mobility Scale
Measure of mobility milestones in critically ill patients.
Time frame: Through study completion, an average of 2 weeks
Long term follow up
Longer-term follow-up for functional status by Barthel Index after three months and one year of discharge
Time frame: After three months and one year of discharge
Level of activity by Perceived Exertion
Level of exercise by Perceived Exertion by Borg Rating of Perceived Exertion Scale
Time frame: approximately 40 minutes after therapy, immediately after the end of the protocol