Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Three minute walk test
研究概览
简要总结
The aim of this study is to evaluate the efficacy of pulmonary physiotherapy on respiratory functions in hospitalized patients with Novel Coronavirus 2019 pneumonia. Patients will be randomized into 1) intervention group: receiving pulmonary physiotherapy technique to improve pulmonary function and walking training or 2) control group: Usual medical care. Patients in both groups will receive therapeutic incentive spirometer. Various outcome measurements of pulmonary functions will be evaluated before and after of interventions. Mortality rate, hospitalization duration and re-admission will be followed until one month after end of intervention. Also, patient's quality of life will be measured after one month.
详细描述
In late December 2019, the new coronavirus (COVID-19) emerged in Wuhan, China and it has been confirmed as the cause of pneumonia in a large number of Chinese patients. The virus, also known as SARS-CoV-2, has since then spread to more than 200 countries worldwide.
The most common symptoms of COVID-19 are fever, dry cough, shortness of breath and tiredness. In severe cases, the infection could cause pneumonia, acute respiratory distress syndrome (ARDS) and sometimes leads to death. Pulmonary physiotherapy is a comprehensive, effective and safe treatment method which is aimed at improving patient's respiratory symptoms, train effective coughing, clear the airway secretion, eliminate exacerbation and so on. It seems that pulmonary physiotherapy interventions can effectively decrease hospitalization, reduce the risk of complications and improve the patient's medical condition.
The aim of this study is to evaluate the effectiveness of the hold breathing technique, chest expansion exercise, postural drainage procedure and Cough techniques carried out during pulmonary physiotherapy sessions.
The researchers will invite 40 hospitalized patients in Imam Khomeini Hospital Complex, Tehran, Iran. All patients will be enrolled after taking informed consent. All of the procedure will be performed with the coordination of the patient's physicians. Patients will be randomized to the intervention or control group. Primary outcome measurements will be evaluated immediately before and after the interventions (with three days period). Also, patient's condition (including process of disease progression, mortality, hospital stay duration and re-admission) will be followed until one month using medical records review and interviewing with the patient or his/her family. Patient's health related quality of life will be measured using short form-36 quality of life assessment tool one month after the end of interventions. Intention-to-treat analysis will be performed in the patients that dropped out of the study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COVID-19 pneumonia confirmed by RT-PCR test and diagnostic radiology.
- •Non-intubated patients
- •Patients with full consciousness
- •Be able to walking and performing exercises.
- •O2 Saturation < 88% when free air breathing.
- •be able to write and read in Farsi
排除标准
- •Any type of musculoskeletal disorder disabling patient to participate to study.
- •Intubation during the period of intervention
- •Patients' dissatisfaction to continue the study for any reason.
结局指标
主要结局
Three minute walk test
时间窗: Day 3
The distance a patient can walk during three minute
Mixed venous O2 pressure (PVO2)
时间窗: Day 3
Partial pressure of oxygen in mixed venous blood.
Mixed venous CO2 pressure (PVCO2)
时间窗: Day 3
Partial pressure of carbon dioxide in mixed venous blood.
PH
时间窗: Day 3
Measure of the venous blood acidity or alkalinity
HCO3
时间窗: Day 3
The amount of bicarbonate ion in the venous blood
Oxygen saturation (O2 Sat) from VBG
时间窗: Day 3
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
O2 Sat after one minute walking
时间窗: Day 3
O2 Sat after two minutes use of Partial Rebreather
时间窗: Day 3
O2 Sat after two minutes free air breathing
时间窗: Day 3
O2 sat/ Fio2
时间窗: Day 3
次要结局
- Mortality rate(until one month)
- Number of participants with Rehospitalization(until one moth)
- The Health-Related Quality of Life (HRQOL)(One month after end of intervention)
- breathlessness(Day 3)
研究者
Mohammad Javaherian
PhD. Candidate of Phyiotherapy
Tehran University of Medical Sciences