The Effect of Inpatient Intensive Early Mobilisation Intervention on Length of Hospital Stay, Medical and Functional Recovery and Readmission Rate of Patients After CABG or AVR/MVR: A Randomized Single Blind Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- High cost medical procedures
研究概览
简要总结
The present study will investigate the volume and extent of the expected physiological effects of "early mobilization" on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus if it may speed up hospital discharge.
详细描述
Although the effects of "early mobilization" have been studied mainly in the intensive care unit setting, the findings could be applied to the surgical units' patients too, since they share common physiological and clinical characteristics. In the literature the effectiveness of "early mobilization" in the length of hospital stay and recovery of the patients operated for coronary artery bypass graft and heart valve replacement in the cardiac surgery setting, is unknown.
The term "early mobilization" is not restricted to a time factor procedure but contains the provision of a customized dynamic set of physical therapy techniques which in studies are variably determined in terms of duration, intensity, frequency and content.
The aim of the study is to determine the clinical effectiveness of the intensive early mobilization physical therapy intervention compared with standard care of physical therapy in the cardio-thoracic surgery clinic of Papageorgiou General Hospital of Thessaloniki.
The present study will investigate the volume and extend of the expected physiological effects of "early mobilization" on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion, hospital mortality and readmission rate of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus may speed up hospital discharge. In the first group of the experimental design, patients will be treated with an intensive early mobilization protocol and the patients of the second group will receive a standard care physical therapy treatment. Controlling for the detailed baseline characteristics that will be assessed during medical history at admission, potential bias will be limited from unmeasured confounders of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and outcomes assessor will be blinded to the protocol each patient will be treated with. Both intervention and standard care protocols will be implemented by a third party.
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
- •Elective CABG or AVR or MVR surgery
- •No previous CABG or valve surgery
- •Isolated / multivessel CABG
排除标准
- •Current neurological disorders
- •Previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise
- •Significant limiting comorbidities that would prevent full participation
结局指标
主要结局
High cost medical procedures
时间窗: Up to 6 weeks
The number of high cost medical procedures the patients will undergo during their postoperative stay in the ward.
Severity of complications
时间窗: Up to 6 weeks
Classification of the complications as "minor" or "major" according to the physicians' expert opinion based on published clinical standards.
Length of postoperative hospital stay
时间窗: Up to 6 weeks
The number of postoperative days that the patients stay in the ward after their surgery procedure and ICU discharge.
Number of complications
时间窗: Up to 6 weeks
The total number of medical events the patients will develop during their postoperative stay in the ward.
Readmission rate
时间窗: Up to 6 weeks
The number of discharged patients that will be readmitted in the hospital for a condition of their underlying disease in a 30 days period after surgery.
Two-minute walk test
时间窗: Up to 6 weeks
The distance in meters that a patient can walk under the specific test conditions, at the day of discharge.
Functional recovery
时间窗: Up to 6 weeks
The time in days that is required for the patients to be autonomous in accessing and using the toilet in their ward.
Time to regain hemodynamic stability
时间窗: Up to 6 weeks
The time in days that is required for the patients to be without inotrope or vasodilator drugs and remain normal and stable in arterial blood pressure, heart rate and blood gas rates.
次要结局
- Hospital mortality(Up to 6 weeks)
研究者
Dimitris Chatzitheodorou
Principal Investigator, Senior Physical Therapist
Papageorgiou General Hospital