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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Physiotherapy Techniques group | Experimental | Pulmonary physiotherapy techniques, 6 sessions during 3 days and incentive spirometer. |
|
| Control group | No Intervention | Incentive spirometer only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Physiotherapy Techniques | Other | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Javaherian, Ph.D. cand. | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam Khomeini Hospital Complex | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31978945 | Background | Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. | |
| 34053269 |
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Individual participant data that underline the results reported in this article, after de-identification
Beginning 3 months and ending 12 months following article publication
Researchers who provide an approved methodologically proposal in the same purpose
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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All the enrolled participants will be allocated to the intervention of control groups using blocked-balanced randomization method.
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|
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 |
| 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 |
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| 36719885 | Derived | Javaherian M, Shadmehr A, Keshtkar A, Beigmohammadi MT, Dabbaghipour N, Syed A, Attarbashi Moghadam B. Safety and efficacy of pulmonary physiotherapy in hospitalized patients with severe COVID-19 pneumonia (PPTCOVID study): A prospective, randomised, single-blind, controlled trial. PLoS One. 2023 Jan 31;18(1):e0268428. doi: 10.1371/journal.pone.0268428. eCollection 2023. |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |