An interventional study of Pulmonary Physiotherapy Techniques in Covid-19, Pneumonia and SARS Pneumonia, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-02.
Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer.
Other: Pulmonary Physiotherapy Techniques
Incentive spirometer only
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).
Mixed venous O2 pressure (PVO2)
Partial pressure of oxygen in mixed venous blood.
Time frame: Baseline
Mixed venous O2 pressure (PVO2)
Partial pressure of oxygen in mixed venous blood.
Time frame: Day 3
Mixed venous CO2 pressure (PVCO2)
Partial pressure of carbon dioxide in mixed venous blood.
Time frame: Baseline
Mixed venous CO2 pressure (PVCO2)
Partial pressure of carbon dioxide in mixed venous blood.
Time frame: Day 3
PH
Measure of the venous blood acidity or alkalinity
Time frame: Baseline
PH
Measure of the venous blood acidity or alkalinity
Time frame: Day 3
HCO3
The amount of bicarbonate ion in the venous blood
Time frame: Baseline
HCO3
The amount of bicarbonate ion in the venous blood
Time frame: Day 3
Oxygen saturation (O2 Sat) from VBG
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Time frame: Baseline
Oxygen saturation (O2 Sat) from VBG
The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood
Time frame: Day 3
Three minute walk test
The distance a patient can walk during three minute
Time frame: Baseline
Three minute walk test
The distance a patient can walk during three minute
Time frame: Day 3
O2 Sat after one minute walking
Time frame: Baseline
O2 Sat after one minute walking
Time frame: Day 3
O2 Sat after two minutes use of Partial Rebreather
Time frame: Baseline
O2 Sat after two minutes use of Partial Rebreather
Time frame: Day 3
O2 Sat after two minutes free air breathing
Time frame: Baseline
O2 Sat after two minutes free air breathing
Time frame: Day 3
O2 sat/ Fio2
Time frame: Baseline
O2 sat/ Fio2
Time frame: Day 3
Mortality rate
The number of dead subjects compared to total patients
Time frame: until one month
Number of participants with Rehospitalization
Patients' hospitalization after discharge due to any reason
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 3
Plan to share: Yes — Individual participant data that underline the results reported in this article, after de-identification
Supporting information: Study protocol, Sap, Icf, Csr
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Tehran University of Medical Sciences