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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Functional status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •transference from other hospital
- •diagnosis of neurological disorders
- •intensive care unit stay < 4 days
- •contraindication to mobilization
研究组 & 干预措施
Control group
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.
干预措施: Conventional Physical Therapy (Other)
Control group
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.
干预措施: Respiratory therapy (Other)
Protocol group
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.
干预措施: Early and progressive mobilization program (Other)
Protocol group
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.
干预措施: Respiratory therapy (Other)
结局指标
主要结局
Functional status
时间窗: At the time of discharge from the ICU, at least 4 days after admission.
Ability to perform daily living activities assessed by Barthel Index
次要结局
- 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.)
- Electromyography muscle activity(At the time of discharge from the ICU, at least 4 days after admission.)
- Pulmonary function(At the time of discharge from the ICU, at least 4 days after admission.)
- Intensive care unit length of stay(At the time of discharge from the ICU, at least 4 days after admission.)
- Maximum inspiratory pressure(At the time of discharge from the ICU, at least 4 days after admission.)
- Peripheral muscle strength(At the time of discharge from the ICU, at least 4 days after admission.)
- Muscle function and mobility(At the time of discharge from the ICU, at least 4 days after admission.)
- ICU mobility Scale(Through study completion, an average of 2 weeks)
- Long term follow up(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)
- Correlation between physiological variables and the level of physical activity(At the time of discharge from the ICU, at least 4 days after admission.)