The Effects of Pulmonary Physiotherapy Treatments on Patients With COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Pulmonary Physiotherapy on Hospitalized Patients With Novel Coronavirus 2019 Pneumonia

Conditions
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Covid-19, Pneumonia, SARS Pneumonia

Intervention / Treatment
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* Other: Pulmonary Physiotherapy Techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary Physiotherapy Techniques group<br>Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer. | Other: Pulmonary Physiotherapy Techniques<br>* Participants will receive pulmonary physiotherapy techniques in six session during three days (twice daily). Four distinguished interventions will be provided for the patients: 1) Chest expansion exercises (for prevention and treatment of potential atelectasis); 2) Techniques to Mobilize or loosen the pulmonary secretions (Active cycle breathing, Coughing techniques, Vibration and Postural drainage); 3) Hold breathing exercise (3 sets, 10 repetition) and; 4) Walking training (based on patient's tolerance until 6 minute).<br>|
| No Intervention: Control group<br>Incentive spirometer only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mixed venous O2 pressure (PVO2) | Partial pressure of oxygen in mixed venous blood. | Baseline | 
| Mixed venous O2 pressure (PVO2) | Partial pressure of oxygen in mixed venous blood. | Day 3 | 
| Mixed venous CO2 pressure (PVCO2) | Partial pressure of carbon dioxide in mixed venous blood. | Baseline | 
| Mixed venous CO2 pressure (PVCO2) | Partial pressure of carbon dioxide in mixed venous blood. | Day 3 | 
| PH | Measure of the venous blood acidity or alkalinity | Baseline | 
| PH | Measure of the venous blood acidity or alkalinity | Day 3 | 
| HCO3 | The amount of bicarbonate ion in the venous blood | Baseline | 
| HCO3 | The amount of bicarbonate ion in the venous blood | Day 3 | 
| Oxygen saturation (O2 Sat) from VBG | The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood | Baseline | 
| Oxygen saturation (O2 Sat) from VBG | The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood | Day 3 | 
| Three minute walk test | The distance a patient can walk during three minute | Baseline | 
| Three minute walk test | The distance a patient can walk during three minute | Day 3 | 
| O2 Sat after one minute walking |  | Baseline | 
| O2 Sat after one minute walking |  | Day 3 | 
| O2 Sat after two minutes use of Partial Rebreather |  | Baseline | 
| O2 Sat after two minutes use of Partial Rebreather |  | Day 3 | 
| O2 Sat after two minutes free air breathing |  | Baseline | 
| O2 Sat after two minutes free air breathing |  | Day 3 | 
| O2 sat/ Fio2 |  | Baseline | 
| O2 sat/ Fio2 |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | The number of dead subjects compared to total patients | until one month | 
| Number of participants with Rehospitalization | Patients' hospitalization after discharge due to any reason | until one moth | 
| The Health-Related Quality of Life (HRQOL) | Using Short-form 36 questionnaire. The minimum score is 0 and the maximum score is 100. Higher scores mean patient's better quality of life. | One month after end of intervention | 
| breathlessness | The amount of shortness of breath using Visual Analogue Scale (VAS). The minimum score is 0 and maximum is 10. The 0 score means no breathlessness and the 10 score is the maximum breathlessness. | Baseline | 
| breathlessness | The amount of shortness of breath using Visual Analogue Scale (VAS). The minimum score is 0 and maximum is 10. The 0 score means no breathlessness and the 10 score is the maximum breathlessness. | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Physiotherapy, 2019 novel coronavirus disease, COVID-19, Rehabilitation