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

Study Overview
=================
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.

Official Title
-----------------
Using a Progressive Mobility Program and Technology to Increase the Level of Physical Activity and Its Benefits in Respiratory, Muscular System and Functionality of ICU Patients: a Randomized Clinical Trial

Conditions
-----------------
Critical Illness, Muscle Weakness

Intervention / Treatment
-----------------
* Other: Conventional Physical Therapy
* Other: Early and progressive mobilization program
* Other: Respiratory therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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. | Other: Conventional Physical Therapy<br>* 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.<br>Other: Respiratory therapy<br>* Respiratory therapy according to the service routine.<br>|
| Experimental: Protocol group<br>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. | Other: Early and progressive mobilization program<br>* 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.<br>Other: Respiratory therapy<br>* Respiratory therapy according to the service routine.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status | Ability to perform daily living activities assessed by Barthel Index | At the time of discharge from the ICU, at least 4 days after admission. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of physical activity during the whole intensive care unit stay | Level of physical activity measured by an accelerometer | At the time of discharge from the ICU, at least 4 days after admission. | 
| Pulmonary function | Pulmonary function assessed by a spirometer | 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 | At the time of discharge from the ICU, at least 4 days after admission. | 
| Peripheral muscle strength | Muscle strength assessed by hand grip dynamometer | 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 | At the time of discharge from the ICU, at least 4 days after admission. | 
| Muscle function and mobility | Test by Time up and Go | At the time of discharge from the ICU, at least 4 days after admission. | 
| Intensive care unit length of stay | Count of the number of days spent at the intensive care unit | 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 | 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. | 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 | 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 | approximately 40 minutes after therapy, immediately after the end of the protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive Care Units, Physical Therapy Specialty, Critical illness, Muscle weakness, Bed rest