Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients
- Conditions
- Muscle WeaknessCritical Illness
- Interventions
- Other: Conventional Physical TherapyOther: Early and progressive mobilization programOther: Respiratory therapy
- Registration Number
- NCT02889146
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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
- transference from other hospital
- diagnosis of neurological disorders
- intensive care unit stay < 4 days
- contraindication to mobilization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protocol group Respiratory therapy 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. Control group Conventional Physical Therapy 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. Control group Respiratory therapy 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. Protocol group Early and progressive mobilization program 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Pulmonary function At the time of discharge from the ICU, at least 4 days after admission. Pulmonary function assessed by a spirometer
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
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
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
Muscle function and mobility At the time of discharge from the ICU, at least 4 days after admission. Test by Time up and Go
ICU mobility Scale Through study completion, an average of 2 weeks Measure of mobility milestones in critically ill patients.
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
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
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
Trial Locations
- Locations (1)
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
🇧🇷Sao Paulo, SP, Brazil