The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Pneumonia With Confirmed COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Vital capacity (Voldyne 5000)
研究概览
简要总结
The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to pneumonia with confirmed COVID-19.
详细描述
The planned group size is 60 patients diagnosed with pneumonia and confirmed COVID-19. The given population was calculated based on the sampling calculator, considering the following parameters: fraction size, confidence level, and maximum error. Eligible patients will be randomly divided into two groups: a study group (30 patients) undergoing pulmonary rehabilitation supplemented with an education program, and a control group (30 patients) undergoing conventional pulmonary rehabilitation. Patients of both groups will be included in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of three hours daily. The program will be applied individually to each patient and include in-bed assisted exercises, airway clearance techniques, effective cough exercises, pursed-lips breathing, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises. Patients from the study group will additionally undergo daily education using an original brochure containing information about self management during the treatment process, the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise. The test will be performed two times: before the start of rehabilitation and after completing the rehabilitation program. The patients' condition and the rehabilitation effects will be assessed using the following measures:
- Vital capacity (Voldyne 5000)
- Oxygen saturation (pulse oximeter)
- Acid-base balance (gasometry)
- Fatigue (modified Borg scale)
- Physical performance (Sit-to-Stand Test)
- Dyspnea assessment (MRC dyspnea scale)
- Anxiety and depression (HADS scale)
- Activities of daily living (Barthel scale)
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization due to pneumonia due to COVID-19
- •Positive SARS-COV-2 PCR test
- •Independence in in-bed sitting position with lower extremities placed on the floor
- •Age 40 y.o. to 70 y.o.
- •No additional respiratory support (e.a. cardiopulmonary bypass machine, ventilator)
- •Informed, voluntary consent to participate in research.
排除标准
- •Hospitalization due to pneumonia with negative SARS-COV-2 PCR test
- •Unstable medical condition hindering performing the examination
- •Age under 40 y.o. and over 70 y.o.
- •Cognitive deficits impairing the ability to understand and execute commands
- •Concomitant oncological, neurological, orthopedic, and psychiatric diseases may affect the examined persons' circulatory and respiratory functions, functional efficiency, quality of life, and emotional state.
- •Failure to complete a 14-day rehabilitation program
- •Lack of informed, voluntary consent to participate in research
结局指标
主要结局
Vital capacity (Voldyne 5000)
时间窗: Second examination- at the end of the 14-day rehabilitation program
Measurements will be performed with certified motivational spirometer, Voldyne 5000. Patient, in a sitting position, will inhale as much air as possible starting from residual volume (RV) level and approach to vital capacity (VC) level. The result will be read from the scale placed on the wall of the device.
Oxygen saturation
时间窗: Second examination- at the end of the 14-day rehabilitation program
Measurements will be performed with pulse oximeter and the parameter analyzed will be SpO2 (oxygen saturation by pulse oximetry; percentage of oxygen in patients' blood).
Acid-base balance
时间窗: Second examination- at the end of the 14-day rehabilitation program
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
次要结局
- Activities of daily living assesment using Barthel scale(Second examination- at the end of the 14-day rehabilitation program)
- Fatigue assessment using modified Borg scale(Second examination- at the end of the 14-day rehabilitation program)
- Physical performance assessment by Sit-to-Stand Test (STS)(Second examination- at the end of the 14-day rehabilitation program)
- Dyspnea assessment with Medical Research Council dyspnea scale(Second examination- at the end of the 14-day rehabilitation program)
- Anxiety and depression assessment using HADS scale(Second examination- at the end of the 14-day rehabilitation program)
研究者
Renata Borys
MSc
University of Rzeszow