Critical Illness, Muscle Weakness
Conditions
Keywords
Intensive Care Units, Physical Therapy Specialty, Critical illness, Muscle weakness, Bed rest
Brief summary
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.
Detailed 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.
Interventions
OTHERConventional Physical Therapy
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.
OTHEREarly and progressive mobilization program
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.
OTHERRespiratory therapy
Respiratory therapy according to the service routine.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional status | At the time of discharge from the ICU, at least 4 days after admission. | Ability to perform daily living activities assessed by Barthel Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | At the time of discharge from the ICU, at least 4 days after admission. | Pulmonary function assessed by a spirometer |
| ICU mobility Scale | Through study completion, an average of 2 weeks | Measure of mobility milestones in critically ill patients. |
| Maximum inspiratory pressure | At the time of discharge from the ICU, at least 4 days after admission. | Maximum inspiratory pressure measured by an specific equipment |
| Peripheral muscle strength | At the time of discharge from the ICU, at least 4 days after admission. | Muscle strength assessed by hand grip dynamometer |
| Electromyography muscle activity | At the time of discharge from the ICU, at least 4 days after admission. | Quadriceps femoris electric activity assessed by surface electromyography |
| Level of physical activity during the whole intensive care unit stay | At the time of discharge from the ICU, at least 4 days after admission. | Level of physical activity measured by an accelerometer |
| Long term follow up | After three months and one year of discharge | Longer-term follow-up for functional status by Barthel Index after three months and one year of discharge |
| Intensive care unit length of stay | At the time of discharge from the ICU, at least 4 days after admission. | Count of the number of days spent at the intensive care unit |
| Correlation between physiological variables and the level of physical activity | At the time of discharge from the ICU, at least 4 days after admission. | Correlation between the physiological variables collected during the study and the level of physical activity measured by the accelerometer |
| Level of activity by Perceived Exertion | approximately 40 minutes after therapy, immediately after the end of the protocol | Level of exercise by Perceived Exertion by Borg Rating of Perceived Exertion Scale |
| Muscle function and mobility | At the time of discharge from the ICU, at least 4 days after admission. | Test by Time up and Go |
Countries
Brazil
Outcome results
None listed